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Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens

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ClinicalTrials.gov Identifier: NCT01354223
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : March 21, 2014
Last Update Posted : March 21, 2014
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: stenfilcon A contact lens
Device: ocufilcon B contact lens
Enrollment 90
Recruitment Details  
Pre-assignment Details Ninety-three subjects evaluated, 3 subjects found to be ineligible and not randomized or dispensed. 90 adapted single-vision contact lens wearers with myopia were randomized and dispensed on a 2 to 1 ratio within each site and across entire study. Subjects used that same assigned product throughout study duration
Arm/Group Title Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Hide Arm/Group Description Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Period Title: Overall Study
Started 60 30
Completed 57 29
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             3             1
Arm/Group Title Stenfilcon A Contact Lens Ocufilcon B Contact Lens Total
Hide Arm/Group Description Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode Total of all reporting groups
Overall Number of Baseline Participants 60 30 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 30 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
 100.0%
30
 100.0%
90
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 30 participants 90 participants
32.6  (8.884) 29.8  (8.550) 31.7  (8.822)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 30 participants 90 participants
Female
38
  63.3%
21
  70.0%
59
  65.6%
Male
22
  36.7%
9
  30.0%
31
  34.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 30 participants 90 participants
60 30 90
1.Primary Outcome
Title Objective Assessment: Ocular Response - Biomicroscopy
Hide Description

The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses.

The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.

Time Frame Change from baseline visit and all follow-ups visits
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings
Arm/Group Title Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Hide Arm/Group Description:
Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Overall Number of Participants Analyzed 57 29
Overall Number of Units Analyzed
Type of Units Analyzed: Unique eyes
114 58
Mean (Full Range)
Unit of Measure: units on a scale
Neovascularization, Baseline
1.00
(1 to 1)
1.00
(1 to 1)
Neovascularization, All Follow-up
1.00
(1 to 1)
1.10
(1 to 2)
Corneal Staining, Baseline
1.00
(1 to 1)
1.00
(1 to 1)
Corneal Staining, All Follow-up
1.09
(1 to 2)
1.18
(1 to 2)
Limbal Hyperemia, Baseline
1.00
(1 to 1)
1.00
(1 to 1)
Limbal Hyperemia, All Follow-up
1.03
(1 to 2)
1.05
(1 to 2)
Bulbar Hyperemia, Baseline
1.00
(1 to 1)
1.00
(1 to 1)
Bulbar Hyperemia, All Follow-up
1.05
(1 to 2)
1.02
(1 to 2)
Palperbral Conjunctiva, Baseline
1.10
(1 to 2)
1.00
(1 to 1)
Palpebral Conjunctiva, All Follow-up
1.38
(1 to 2)
1.00
(1 to 1)
2.Primary Outcome
Title Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
Hide Description

The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses.

The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).

Time Frame Any occurrence from dispensing to month 3 visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Unique eyes are defined as each individual eye in the study.
Arm/Group Title Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Hide Arm/Group Description:
Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Overall Number of Participants Analyzed 57 29
Overall Number of Units Analyzed
Type of Units Analyzed: Unique eyes
114 58
Measure Type: Number
Unit of Measure: number of adverse events
7 1
3.Primary Outcome
Title Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better
Hide Description

The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B.

Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.

Time Frame week 1 visit, week 2 visit, month 1 visit, month 2 visit combined
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For the completed study subjects, contact lens VA was collected at 562 of the possible 564 examinations (99.6%) for the Test cohort eyes and at 288 of the possible 288 examinations (100%) for the Control cohort eyes.
Arm/Group Title Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Hide Arm/Group Description:
Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Overall Number of Participants Analyzed 57 29
Overall Number of Units Analyzed
Type of Units Analyzed: Possible examinations
562 288
Measure Type: Number
Unit of Measure: percentage of possible examinations
99.3 100
4.Secondary Outcome
Title Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort
Hide Description

The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens.

Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3).

Time Frame Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Unique eyes reporting no symptoms of discomfort/Pain, excessive tearing, photophobia, halos, itching/burning, dryness, variable vision, blurred vision, other symptoms.
Arm/Group Title Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Hide Arm/Group Description:
Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Overall Number of Participants Analyzed 57 29
Overall Number of Units Analyzed
Type of Units Analyzed: Unique eyes
114 58
Measure Type: Number
Unit of Measure: percentage of eyes
Baseline 73.6 70.4
Week 1 43.9 50.0
Week 2 60.9 55.2
Month 1 55.4 60.3
Month 2 59.6 55.2
Month 3 55.3 58.6
5.Secondary Outcome
Title Evaluation of Average Lens Wearing Time - Average Daily Hours Worn
Hide Description The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.
Time Frame Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Hide Arm/Group Description:
Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Overall Number of Participants Analyzed 57 29
Mean (Standard Deviation)
Unit of Measure: hours
Baseline 15.04  (3.846) 13.74  (4.182)
Week 1 13.71  (2.281) 13.18  (2.539)
Week 2 13.69  (2.235) 13.31  (2.523)
Month 1 13.67  (2.520) 12.81  (2.640)
Month 2 13.81  (2.774) 13.41  (2.693)
Month 3 14.00  (2.440) 13.28  (2.576)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Hide Arm/Group Description Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
All-Cause Mortality
Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stenfilcon A Contact Lens Ocufilcon B Contact Lens
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/60 (5.00%)      0/30 (0.00%)    
Eye disorders     
Papillary Conjunctivitis   3/60 (5.00%)  6 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Release of this data (through presentation, publication or other written or oral communication) to other than listed personnel (listed in protocol) requires the prior written permission from the study Sponsor. Study investigators and all office personnel are prohibited from acknowledging participation in the study to individuals and organizations except those listed.
Results Point of Contact
Name/Title: William J. Gleason, O.D.
Organization: Foresight Regulatory Strategies, Inc.
Phone: 978-658-6888 ext 151
Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01354223     History of Changes
Other Study ID Numbers: FC100239
First Submitted: January 10, 2011
First Posted: May 16, 2011
Results First Submitted: October 23, 2013
Results First Posted: March 21, 2014
Last Update Posted: March 21, 2014