Evaluation of the Feasibility 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 an investigational contact lens.

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 in each eye. 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: 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

Primary Purpose: Other
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 lens | Device: Investigational lens<br>* Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.<br>|
| Active Comparator: Air Optix Aqua lens<br>Ciba Vision Air Optix Aqua contact lens | Device: Air Optix Aqua lens<br>* Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 1 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities. | At 1 week follow up | 
| Symptoms and Complaints | At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score. | At 1 week follow up |