NCT01131130
Completed
Not Applicable
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Lens
ConditionsMyopia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must have clear central corneas and be free of any anterior segment disorders.
- •Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- •Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.
Exclusion Criteria
- •Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- •Participants with any systemic disease affecting ocular health.
- •Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Participants with an active ocular disease or are using any ocular medication.
- •Participants who have had any corneal surgery (eg, refractive surgery).
- •Participants who are allergic to any component in the study care products.
Outcomes
Primary Outcomes
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
Time Frame: 7 days
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Comfort Throughout the Day - Test Lens vs. Acuvue Oasys
Time Frame: 7 days
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Secondary Outcomes
- Lens Wettability, Test Lens vs. Acuvue Oasys(7 days)
- Lens Wettability, Test Lens vs. Air Optix Aqua(7 days)
Study Sites (1)
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