Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Product Feasibility of a New Silicone Hydrogel Contact Lens

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: NCT01309100
Recruitment Status : Completed
First Posted : March 4, 2011
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant)
Condition Myopia
Interventions Device: Investigational Lens
Device: Acuvue Oasys Lens
Device: Air Optix Aqua Lens
Enrollment 144
Recruitment Details This was a randomized, bilateral, three-way crossover, subject-masked study conducted at six sites in the United States. The first participant was enrolled 11/8/2010 and last participant exited on 12/23/2010.
Pre-assignment Details 144 participants were equally randomized to one of six treatment sequences. 142 participants completed the study.
Arm/Group Title Overall Study
Hide Arm/Group Description Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
Period Title: Overall Study
Started 144
Completed 142
Not Completed 2
Reason Not Completed
Protocol Violation             1
Positive Slit lamp finding             1
Arm/Group Title Overall Study
Hide Arm/Group Description Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
Overall Number of Baseline Participants 144
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 144 participants
30.6  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants
Female
96
  66.7%
Male
48
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 144 participants
144
1.Primary Outcome
Title Visual Acuity (Investigational vs Air Optix Aqua Lens)
Hide Description The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible, dispensed eyes
Arm/Group Title Investigational Lens Air Optix Aqua Lens
Hide Arm/Group Description:

Bausch & Lomb investigational silicone hydrogel lens (RD2117-01).

Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.

Ciba Vision Air Optix Aqua contact lens.

Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.

Overall Number of Participants Analyzed 143 143
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
286 286
Least Squares Mean (Standard Deviation)
Unit of Measure: LogMAR
Baseline -0.050  (0.116) -0.060  (0.116)
1 Week follow-up -0.034  (0.111) -0.039  (0.111)
2.Primary Outcome
Title Visual Acuity (Investigational vs Acuvue Oasys Lens)
Hide Description The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible, dispensed eyes
Arm/Group Title Investigational Lens Acuvue Oasys Lens
Hide Arm/Group Description:

Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).

Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.

Johnson & Johnson Acuvue Oasys contact lens.

Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.

Overall Number of Participants Analyzed 143 143
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
286 286
Least Squares Mean (Standard Deviation)
Unit of Measure: LogMAR
Baseline -0.050  (0.113) -0.048  (0.113)
1-week follow-up -0.034  (0.109) -0.033  (0.109)
3.Secondary Outcome
Title Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)
Hide Description The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
1-Week Follow-up, All Eligible, Dispensed Eyes
Arm/Group Title Investigational Lens Acuvue Oasys Lens
Hide Arm/Group Description:

Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).

Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.

Johnson & Johnson Acuvue Oasys contact lens.

Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.

Overall Number of Participants Analyzed 143 143
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
286 286
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
80.9  (21.4) 86.5  (21.4)
4.Secondary Outcome
Title Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)
Hide Description The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible, dispensed eyes
Arm/Group Title Investigational Lens Air Optix Aqua Lens
Hide Arm/Group Description:

Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).

Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.

Ciba Vision Air Optix Aqua contact lens.

Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.

Overall Number of Participants Analyzed 143 142
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
286 284
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
80.9  (21.4) 82.1  (21.4)
Time Frame 3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   0/144 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall Study
Affected / at Risk (%)
Total   0/144 (0.00%) 
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Steffen
Organization: Bausch & Lomb
Phone: 585 338 6399
EMail: robert.steffen@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01309100    
Other Study ID Numbers: 672E
First Submitted: March 3, 2011
First Posted: March 4, 2011
Results First Submitted: March 27, 2014
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014