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Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01965288
Recruitment Status : Completed
First Posted : October 18, 2013
Results First Posted : November 10, 2014
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Astigmatism
Interventions Device: comfilcon A
Device: lotrafilcon B
Enrollment 60
Recruitment Details

Of the 60 subjects enrolled, 60 were fitted with the study lenses and completed the trial (i.e.

no discontinuations).This study design considered a single-center, (Optometry Research Group), located at the University of Valencia Spain (target 60 subjects).

Pre-assignment Details All subjects were habitual lens wearers.
Arm/Group Title Comfilcon A Then Lotrafilcon B Lotrafilcon B Then Comfilcon A
Hide Arm/Group Description All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Comfilcon A Then Lotrafilcon B Lotrafilcon B Then Comfilcon A Total
Hide Arm/Group Description All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
The subject sample consisted of sixty (60) habitual toric contact lens wearers.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
16
  53.3%
21
  70.0%
37
  61.7%
Male
14
  46.7%
9
  30.0%
23
  38.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Daily and Comfortable Wearing Time
Hide Description Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: hours
Average comfortable wearing time 8.8  (2.5)
Average daily wearing time 9.2  (2.6)
2.Primary Outcome
Title Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
Hide Description Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
Comfort on Insertion 8.0  (1.3)
Comfort prior to Removal 7.7  (1.6)
Comfort Overall 8.0  (1.6)
Dryness during the Day 8.0  (1.6)
Dryness prior to Removal 7.9  (1.6)
Dryness Overall 7.9  (1.6)
Handling 8.4  (1.1)
Overall Lens Fit 8.2  (1.1)
Overall Vision Satisfaction 8.1  (1.2)
3.Primary Outcome
Title Vision Quality Insertion, During Day, End Day
Hide Description Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
On Insertion 78.5  (12.4)
During the Day 82.7  (13.2)
End of Day 80.2  (14.3)
4.Primary Outcome
Title Vision Stability Insertion, During Day, End Day
Hide Description Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
On Insertion 78.5  (12.0)
During the Day 83.8  (13.4)
End of Day 82.9  (13.3)
5.Primary Outcome
Title Overall Sensation of Moistness
Hide Description Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of subjects
Excellent 23
Good 25
Average 50
Below Average 0
Poor 2
6.Primary Outcome
Title Overall Sensation of Smoothness
Hide Description Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
Excellent 27
Good 33
Average 40
Below Average 0
Poor 0
7.Primary Outcome
Title Comfort Satisfaction
Hide Description Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 37
Somewhat Satisfied 55
Somewhat Dissatisfied 7
Completely Dissatisfied 2
8.Primary Outcome
Title Dryness Satisfaction
Hide Description Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 33
Somewhat Satisfied 53
Somewhat Dissatisfied 12
Completely Dissatisfied 2
9.Primary Outcome
Title Handling Satisfaction
Hide Description Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 57
Somewhat Satisfied 37
Somewhat Dissatisfied 5
Completely Dissatisfied 2
10.Primary Outcome
Title Lens Fit Satisfaction
Hide Description Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 42
Somewhat Satisfied 50
Somewhat Dissatisfied 8
Completely Dissatisfied 0
11.Primary Outcome
Title Vision Satisfaction
Hide Description Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 48
Somewhat Satisfied 45
Somewhat Dissatisfied 7
Completely Dissatisfied 0
12.Primary Outcome
Title Overall Satisfaction
Hide Description Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects wearing habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 40
Somewhat Satisfied 53
Somewhat Dissatisfied 7
Completely Dissatisfied 0
13.Primary Outcome
Title Comfort Upon Contact Lens Insertion
Hide Description Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.0  (0.8) 7.8  (1.2)
14.Primary Outcome
Title Vision Satisfaction Upon Contact Lens Insertion
Hide Description Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.8  (1.1) 8.2  (1.3)
15.Primary Outcome
Title Vision Quality With Contact Lens Prescription
Hide Description Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
88  (9.3) 82  (11.9)
16.Primary Outcome
Title Vision Stability Upon Contact Lens Insertion
Hide Description Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
87  (11.9) 82  (11.7)
17.Primary Outcome
Title Visual Acuity logMAR
Hide Description Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Log Mean (Standard Deviation)
Unit of Measure: logMAR
MHCVA (OU Average) -0.02  (0.05) -0.01  (0.06)
MLCVA (OU Average) 0.18  (0.05) 0.19  (0.07)
BHCVA -0.04  (0.06) -0.02  (0.05)
BLCVA 0.17  (0.07) 0.18  (0.05)
18.Primary Outcome
Title Centration
Hide Description Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
centered 94 79
slightly decentered 6 21
19.Primary Outcome
Title Corneal Coverage
Hide Description Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
100 100
20.Primary Outcome
Title Post Blink Movement
Hide Description Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.09  (0.30) 0.19  (0.42)
21.Primary Outcome
Title Lens Orientation Primary Gaze
Hide Description Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: degrees
0.71  (1.75) 1.06  (1.90)
22.Primary Outcome
Title Lens Marking Visibility
Hide Description Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
Excellent 89 42
Average 11 42
Poor 0 16
23.Primary Outcome
Title Lens Stability on Blink
Hide Description Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
No rotation 100 98
5-10 degrees 0 2
24.Primary Outcome
Title Lens Stability 5-10 Min
Hide Description Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
100 100
25.Primary Outcome
Title Lens Overall Stability
Hide Description Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
Excellent 80 50
Good 20 50
26.Primary Outcome
Title Rotational Recovery 30/45 Deg
Hide Description Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: degrees
30 deg/ 10 blinks 0.542  (1.56) 0.833  (1.98)
45 deg/ 60 sec 0.625  (1.66) 0.875  (2.01)
27.Primary Outcome
Title Overall Fit Acceptance
Hide Description Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)
Time Frame Dispense
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses fitted
Perfect 82 57
Not Perfect 18 43
28.Primary Outcome
Title Daily and Comfortable Wearing Time
Hide Description Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: hours
average comfortable wearing time 9.8  (2.3) 8.3  (3.0)
average daily wearing time 10.1  (2.0) 10.1  (1.8)
29.Primary Outcome
Title Daily and Comfortable Wearing Time
Hide Description Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: hours
average comfortable wearing time 9.5  (2.1) 7.8  (2.8)
average daily wearing time 9.9  (1.7) 9.8  (1.7)
30.Primary Outcome
Title Participants Use of Rewetting Drops
Hide Description Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
7 50
31.Primary Outcome
Title Participants Use of Rewetting Drops
Hide Description Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
15 58
32.Primary Outcome
Title Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
Hide Description Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
Comfort on Insertion 8.7  (1.1) 7.7  (1.3)
Comfort prior to Removal 8.7  (1.1) 7.4  (1.4)
Comfort Overall 8.8  (1.1) 7.6  (1.3)
Dryness during the Day 8.7  (1.3) 7.6  (1.4)
Dryness prior to Removal 8.6  (1.5) 7.5  (1.5)
Dryness Overall 8.7  (1.3) 7.5  (1.5)
Handling 8.3  (1.1) 8.0  (1.6)
Lens Fit Stability 8.8  (1.2) 8.0  (1.5)
Vision Satisfaction 8.7  (1.1) 8.0  (1.5)
33.Primary Outcome
Title Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
Hide Description Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
Comfort on Insertion 8.6  (1.0) 7.1  (1.5)
Comfort prior to Removal 8.5  (1.1) 6.7  (1.6)
Comfort Overall 8.6  (1.1) 6.9  (1.6)
Dryness during the Day 8.5  (1.1) 7.0  (1.6)
Dryness prior to Removal 8.5  (1.1) 7.0  (1.5)
Dryness Overall 8.6  (1.1) 7.0  (1.6)
Handling 8.2  (1.1) 7.8  (1.7)
Lens Fit Stability 8.6  (1.1) 7.6  (1.6)
Vision Satisfaction 8.5  (1.0) 7.6  (1.6)
34.Primary Outcome
Title Vision Quality Insertion, During Day, End Day, Night
Hide Description Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
On Insertion 88  (8) 84  (9)
During the Day 89  (9) 85  (10)
End of Day 87  (9) 83  (11)
Night 84  (9) 80  (12)
35.Primary Outcome
Title Vision Quality Insertion, During Day, End Day, Night
Hide Description Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
On Insertion 85  (10) 79  (11)
During the Day 88  (10) 82  (13)
End of Day 86  (11) 80  (13)
Night 83  (10) 76  (12)
36.Primary Outcome
Title Vision Stability on Insertion, During Day, End Day
Hide Description Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
On Insertion 87  (9) 83  (11)
During the Day 91  (9) 85  (13)
End of Day 89  (10) 84  (12)
37.Primary Outcome
Title Vision Stability on Insertion, During Day, End Day
Hide Description Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
On Insertion 85  (10) 80  (13)
During the Day 87  (11) 82  (14)
End of Day 86  (9) 80  (13)
38.Primary Outcome
Title Overall Sensation of Moistness
Hide Description Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Excellent 57 20
Good 30 30
Average 13 33
Below Average 0 12
Poor 0 5
39.Primary Outcome
Title Overall Sensation of Moistness
Hide Description Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Excellent 60 18
Good 27 23
Average 12 30
Below Average 2 25
Poor 0 3
40.Primary Outcome
Title Overall Sensation of Smoothness
Hide Description Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Excellent 48 27
Good 38 30
Average 13 30
Below Average 0 12
Poor 0 2
41.Primary Outcome
Title Overall Sensation of Smoothness
Hide Description Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Excellent 47 13
Good 42 38
Average 10 28
Below Average 2 17
Poor 0 3
42.Primary Outcome
Title Comfort Satisfaction
Hide Description Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 72 25
Somewhat Satisfied 23 45
Somewhat Dissatisfied 5 28
Completely Dissatisfied 0 2
43.Primary Outcome
Title Comfort Satisfaction
Hide Description Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 72 27
Somewhat Satisfied 23 37
Somewhat Dissatisfied 5 27
Completely Dissatisfied 0 10
44.Primary Outcome
Title Dryness Satisfaction
Hide Description Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 73 32
Somewhat Satisfied 27 42
Somewhat Dissatisfied 0 25
Completely Dissatisfied 0 1.7
45.Primary Outcome
Title Dryness Satisfaction
Hide Description Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 77 23
Somewhat Satisfied 13 35
Somewhat Dissatisfied 10 32
Completely Dissatisfied 0 10
46.Primary Outcome
Title Handling Satisfaction
Hide Description Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 47 45
Somewhat Satisfied 42 43
Somewhat Dissatisfied 12 10
Completely Dissatisfied 0 1.7
47.Primary Outcome
Title Handling Satisfaction
Hide Description Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 42 40
Somewhat Satisfied 48 48
Somewhat Dissatisfied 10 12
Completely Dissatisfied 0 0
48.Primary Outcome
Title Vision Satisfaction
Hide Description Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 70 43
Somewhat Satisfied 30 48
Somewhat Dissatisfied 0 7
Completely Dissatisfied 0 2
49.Primary Outcome
Title Vision Satisfaction
Hide Description Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 63 35
Somewhat Satisfied 32 53
Somewhat Dissatisfied 5 12
Completely Dissatisfied 0 0
50.Primary Outcome
Title Lens Fit Satisfaction
Hide Description Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 70 45
Somewhat Satisfied 27 47
Somewhat Dissatisfied 3 7
Completely Dissatisfied 0 2
51.Primary Outcome
Title Lens Fit Satisfaction
Hide Description Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 70 35
Somewhat Satisfied 25 55
Somewhat Dissatisfied 5 10
Completely Dissatisfied 0 0
52.Primary Outcome
Title Overall Satisfaction
Hide Description Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 68 30
Somewhat Satisfied 30 45
Somewhat Dissatisfied 2 23
Completely Dissatisfied 0 2
53.Primary Outcome
Title Overall Satisfaction
Hide Description Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Completely Satisfied 65 22
Somewhat Satisfied 28 45
Somewhat Dissatisfied 7 27
Completely Dissatisfied 0 7
54.Primary Outcome
Title Wavefront Aberrations Root Mean Square (RMS) (3mm)
Hide Description Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: microns
HOA 0.065  (0.061) 0.07  (0.066)
Third Order 0.043  (0.054) 0.046  (0.041)
Fourth Order 0.034  (0.049) 0.029  (0.051)
55.Primary Outcome
Title Wavefront Aberrations RMS (3mm)
Hide Description Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: microns
HOA 0.071  (0.052) 0.075  (0.063)
Third Order 0.047  (0.051) 0.05  (0.048)
Fourth Order 0.033  (0.061) 0.03  (0.059)
56.Primary Outcome
Title Wavefront Aberrations RMS (5mm)
Hide Description Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: microns
HOA 0.214  (0.052) 0.223  (0.063)
Third Order 0.156  (0.041) 0.161  (0.052)
Fourth Order 0.071  (0.031) 0.075  (0.032)
57.Primary Outcome
Title Wavefront Aberrations RMS (5mm)
Hide Description Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Mean (Standard Deviation)
Unit of Measure: microns
HOA 0.261  (0.065) 0.287  (0.075)
Third Order 0.161  (0.042) 0.167  (0.055)
Fourth Order 0.075  (0.0291) 0.081  (0.034)
58.Primary Outcome
Title Visual Acuity logMAR
Hide Description

Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA).

Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)

Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Log Mean (Standard Deviation)
Unit of Measure: logMAR
MHCVA (both eyes Average) -0.01  (0.05) -0.01  (0.05)
MLCVA (both eyes Average) 0.19  (0.05) 0.19  (0.05)
BHCVA -0.04  (0.05) -0.03  (0.05)
BLCVA 0.17  (0.05) 0.18  (0.05)
59.Primary Outcome
Title Visual Acuity logMAR
Hide Description

Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA).

Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)

Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Log Mean (Standard Deviation)
Unit of Measure: logMAR
MHCVA (both eyes Average) -0.01  (0.05) -0.01  (0.05)
MLCVA (both eyes Average) 0.19  (0.05) 0.19  (0.05)
BHCVA -0.03  (0.05) -0.03  (0.05)
BLCVA 0.18  (0.05) 0.18  (0.05)
60.Primary Outcome
Title Lens Orientation Primary Gaze
Hide Description Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: degrees
0.67  (1.71) 1.17  (2.22)
61.Primary Outcome
Title Lens Orientation Primary Gaze
Hide Description Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: degrees
0.87  (2.01) 1.08  (2.17)
62.Primary Outcome
Title Rotational Recovery 30/45 Deg
Hide Description Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: degrees
30 deg/ 10 blinks 0.25  (1.09) 0.83  (1.98)
45 deg/ 60 sec 0.58  (1.61) 0.96  (2.08)
63.Primary Outcome
Title Rotational Recovery 30/45 Deg
Hide Description Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: degrees
30 deg/ 10 blinks 0.33  (1.25) 0.66  (1.82)
45 deg/ 60 sec 0.45  (1.45) 0.63  (1.78)
64.Primary Outcome
Title Lens Surface Deposits
Hide Description Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.26  (0.31) 0.41  (0.36)
65.Primary Outcome
Title Lens Surface Deposits
Hide Description Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.41  (0.34) 0.71  (0.41)
66.Primary Outcome
Title Centration
Hide Description Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
centered 94 78
slightly decentered 6 22
67.Primary Outcome
Title Centration
Hide Description Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
centered 93 81
slightly decentered 7 19
68.Primary Outcome
Title Corneal Coverage
Hide Description Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
100 100
69.Primary Outcome
Title Corneal Coverage
Hide Description Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
100 100
70.Primary Outcome
Title Post Blink Movement
Hide Description Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0  (0) 0.05  (0.22)
71.Primary Outcome
Title Post Blink Movement
Hide Description Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.01  (0.09) 0.05  (0.22)
72.Primary Outcome
Title Lens Marking Visibility
Hide Description Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
Excellent 88 27
Average 12 49
Poor 0 24
73.Primary Outcome
Title Lens Marking Visibility
Hide Description Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
Excellent 84 20
Average 16 50
Poor 0 30
74.Primary Outcome
Title Lens Stability on Blink
Hide Description Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
No rotation 98 99
5-10 degrees 2 1
75.Primary Outcome
Title Lens Stability on Blink
Hide Description Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
No rotation 100 99
5-10 degrees 0 1
76.Primary Outcome
Title Lens Stability 5-10 Min
Hide Description Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
100 100
77.Primary Outcome
Title Lens Stability 5-10 Min
Hide Description Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
100 100
78.Primary Outcome
Title Overall Stability
Hide Description Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
Excellent 74 38
Good 26 62
79.Primary Outcome
Title Overall Stability
Hide Description Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
Excellent 72 36
Good 28 64
80.Primary Outcome
Title Overall Fit Acceptance
Hide Description Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
Perfect 76 49
Not Perfect 24 51
81.Primary Outcome
Title Overall Fit Acceptance
Hide Description Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
120 120
Measure Type: Number
Unit of Measure: percentage of lenses
Perfect 73 44
Not Perfect 27 56
82.Secondary Outcome
Title Limbal Hyperaemia
Hide Description Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects after removal of habitual lens and prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 97.5
Grade 1/2 2.5
Grade 1 0.0
83.Secondary Outcome
Title Limbal Hyperaemia
Hide Description Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 99 100
Grade 1/2 1 0
Grade 1 0 0
84.Secondary Outcome
Title Limbal Hyperaemia
Hide Description Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 98 98
Grade 1/2 2 2
Grade 1 0 0
85.Secondary Outcome
Title Bulbar Hyperaemia
Hide Description Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects with habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 98.4
Grade 1/2 1.6
Grade 1 0.0
86.Secondary Outcome
Title Bulbar Hyperaemia
Hide Description Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100 95
Grade 1/2 0 5
Grade 1 0 0
87.Secondary Outcome
Title Bulbar Hyperaemia
Hide Description Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100 94
Grade 1/2 0 6
Grade 1 0 0
88.Secondary Outcome
Title Lower Palpebral Hyperaemia
Hide Description Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects with habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 92.5
Grade 1/2 7.5
Grade 1 0.0
89.Secondary Outcome
Title Lower Palpebral Hyperaemia
Hide Description Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 96 82
Grade 1/2 4 18
Grade 1 0 0
90.Secondary Outcome
Title Lower Palpebral Hyperaemia
Hide Description Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 93 78
Grade 1/2 7 20
Grade 1 0 2
91.Secondary Outcome
Title Corneal Stromal Haze
Hide Description Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects with habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100
Grade 1/2 0.0
Grade 1 0.0
92.Secondary Outcome
Title Corneal Stromal Haze
Hide Description Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100 100
Grade 1/2 0 0
Grade 1 0 0
93.Secondary Outcome
Title Corneal Stromal Haze
Hide Description Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100 100
Grade 1/2 0 0
Grade 1 0 0
94.Secondary Outcome
Title Corneal Neovascularization
Hide Description Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects with habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 96.7
Grade 1/2 3.3
Grade 1 0.0
95.Secondary Outcome
Title Corneal Neovascularization
Hide Description Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100 96
Grade 1/2 0 4
Grade 1 0 0
96.Secondary Outcome
Title Corneal Neovascularization
Hide Description Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100 97
Grade 1/2 0 3
Grade 1 0 0
97.Secondary Outcome
Title Corneal Infiltrates
Hide Description Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
All 60 subjects with habitual lens prior to dispense of study lens.
Overall Number of Participants Analyzed 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100
Grade 1/2 0.0
Grade 1 0.0
98.Secondary Outcome
Title Corneal Infiltrates
Hide Description Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100 100
Grade 1/2 0 0
Grade 1 0 0
99.Secondary Outcome
Title Corneal Infiltrates
Hide Description Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Grade 0 100 100
Grade 1/2 0 0
Grade 1 0 0
100.Secondary Outcome
Title Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)
Hide Description Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.
Arm/Group Title Habitual Lenses Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of patients
Comfort 55 45
Dryness 57 43
Handling 55 45
Vision 47 53
Lens Fit 43 57
Overall 53 47
101.Secondary Outcome
Title Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)
Hide Description Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.
Arm/Group Title Habitual Lenses Comfilcon A
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of patients
Comfort 20 80
Dryness 18 82
Handling 55 45
Vision 25 75
Lens Fit 30 70
Overall 25 75
102.Secondary Outcome
Title Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)
Hide Description Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.
Arm/Group Title Habitual Lenses Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Comfort 62 38
Dryness 58 42
Handling 57 43
Vision 45 55
Lens Fit 52 48
Overall 55 45
103.Secondary Outcome
Title Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)
Hide Description Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.
Arm/Group Title Habitual Lenses Comfilcon A
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Comfort 20 80
Dryness 22 78
Handling 52 48
Vision 27 73
Lens Fit 27 73
Overall 23 77
104.Secondary Outcome
Title Participants Likelihood of Switching From Habitual Lenses to the Study Lenses
Hide Description Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses?" Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of particpants
Very Likely 45 10
Likely 32 32
Unlikely 22 42
Very Unlikely 2 17
105.Secondary Outcome
Title Participants Likelihood of Continuing to Wear the Study Lenses.
Hide Description Participants likelihood of continuing to wear either of the pairs of study lenses when asked; "How likely are they to continue to wearing either the first study lenses or the second study lenses?" Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Very Likely 45 12
Likely 32 30
Unlikely 22 42
Very Unlikely 2 17
106.Secondary Outcome
Title Participant Recommendation of a Study Lens to Friends, Family or Colleagues
Hide Description Percentage of participants that answer the question, "What study lens they will most likely recommend to friends, family or colleagues?" Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
77 23
107.Secondary Outcome
Title Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.
Hide Description Percentage of participants that answer the question, "How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues?" Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects randomized to both sets of lenses.
Arm/Group Title Comfilcon A Lotrafilcon B
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Very Likely 52 15
Likely 35 40
Unlikely 11 35
Very Unlikely 2 10
108.Secondary Outcome
Title Participant Preference for Their Habitual Lenses or Either of the Study Lenses
Hide Description Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects wore habitual lenses prior to randomization of study lenses.
Arm/Group Title Comfilcon A Lotrafilcon B Habitual
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Comfort 72 15 13
Dryness 68 17 15
Handling 27 42 31
Lens Fit 47 42 11
Vision 60 30 10
Overall 65 23 12
109.Secondary Outcome
Title Participant Preference for Either of the Study Lenses
Hide Description Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; first study lenses, second study lenses, neither)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 60 subjects wore habitual lenses prior to randomization of study lenses.
Arm/Group Title Comfilcon A Lotrafilcon B Neither
Hide Arm/Group Description:
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Number of Participants Analyzed 60 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Comfort 80 20 0
Dryness 80 20 0
Handling 40 55 5
Lens Fit 58 38 4