Evaluation of a New Silicone Hydrogel Contact Lens

Study Overview
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Brief Summary
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The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.

Official Title
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A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Test lens
* Device: Air Optix Aqua


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. Exclusion Criteria: Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months. Any systemic disease affecting ocular health. Using any systemic or topical medications that will affect ocular physiology or lens performance. An active ocular disease, any corneal infiltrative response or are using any ocular medications. Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Allergic to any component in the study care products.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Air Optix Aqua<br>Ciba Vision daily wear contact lens | Device: Air Optix Aqua<br>* Air Optix Aqua contact lens worn on a daily wear basis<br>|
| Experimental: Test Lens<br>Investigational silicone hydrogel contact lens | Device: Test lens<br>* Investigational silicone hydrogel contact lens worn on a daily wear basis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up. | Dispensing & 1-week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings | Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates. | 1 week | 
| Comfort | At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score. | 1 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens