A Study to Evaluate the Product Feasibility 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: Bausch & Lomb Test lens
* Device: Ciba Vision soft contact 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 (greater than grade 1 and/or presence of infiltrates). Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye. Exclusion Criteria: An active ocular disease, any corneal infiltrative response or are using any ocular medications. Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months. Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Any scar or neovascularization within the central 4mm of the cornea. Have had any corneal surgery. Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Any systemic disease affecting ocular health. Using any systemic or topical medications that will affect ocular physiology or lens performance. Currently wear monovision, multifocal, or toric contact lenses. 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

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bausch & Lomb Test Lens<br>Bausch + Lomb investigational soft contact lens | Device: Bausch & Lomb Test lens<br>* Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.<br>|
| Active Comparator: Ciba Vision soft contact lens<br>Ciba Vision Air Optix Aqua soft contact lens | Device: Ciba Vision soft contact lens<br>* Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups. | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score. | One week |