A Study to Evaluate 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.

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: Investigational Lens
* Device: Air Optix Aqua lens


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 myopic and require lens correction from -0.50 D to -5.50 D in each eye. Exclusion Criteria: 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 |
| --- | --- |
| Experimental: Investigational Lens<br>Bausch & Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week. | Device: Investigational Lens<br>* Lenses worn on a daily wear basis for one week<br>Device: Air Optix Aqua lens<br>* Lenses worn on a daily wear basis for one week<br>|
| Active Comparator: Air Optix Aqua Lens<br>Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week. | Device: Investigational Lens<br>* Lenses worn on a daily wear basis for one week<br>Device: Air Optix Aqua lens<br>* Lenses worn on a daily wear basis for one week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance High Contrast logMAR Visual Acuity at 1 Week | Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week | Baseline & 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings ≥ Grade 2 | Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea. | 1 week | 
| Overall Comfort | Comfort measured by participant on a scale of 0-100 with 100 being the most favorable. | 1 week | 

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