Feasibility of a New Silicone Hydrogel Lens

Study Overview
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Brief Summary
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: Investigational contact lens
* Device: Acuvue Oasys Contact Lens
* Device: Air Optix Aqua


Participation Criteria
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Eligibility Criteria
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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.

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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No

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 |
| --- | --- |
| Experimental: Investigational contact lens<br>Bausch & Lomb | Device: Investigational contact lens<br>* After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.<br>|
| Active Comparator: Acuvue Oasys Contact Lens<br>Johnson & Johnson Lens | Device: Acuvue Oasys Contact Lens<br>* After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.<br>|
| Active Comparator: Air Optix Aqua<br>Ciba Vision | Device: Air Optix Aqua<br>* After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens | Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable. | 7 days | 
| Comfort Throughout the Day - Test Lens vs. Acuvue Oasys | Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Wettability, Test Lens vs. Acuvue Oasys | Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size). | 7 days | 
| Lens Wettability, Test Lens vs. Air Optix Aqua | Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size). | 7 days | 

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