A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.

Official Title
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A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

Conditions
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Myopia

Intervention / Treatment
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* Device: B&L Investigational Contact Lens
* Device: B&L PureVision Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have clear central corneas and be free of any anterior segment disorders. Subjects must be myopic, and wear contact lenses in each eye. Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months. Exclusion Criteria: Subjects who are older than age 40 on the date the informed consent (ICF) is signed. Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. Subjects with an active ocular disease or who are using any ocular medication. Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible. Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Subjects who are allergic to any component in the study care products.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B&L Investigational Contact Lens<br>The Bausch + Lomb investigational silicone hydrogel contact lens | Device: B&L Investigational Contact Lens<br>* Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.<br>|
| Active Comparator: B&L PureVision Contact Lens<br>The Bausch + Lomb PureVision silicone hydrogel contact lens | Device: B&L PureVision Contact Lens<br>* Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity (VA) | Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months. | 4 visits over 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp > Grade 2 | Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses. | 3 months | 

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