Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

Study Overview
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Brief Summary
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The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.

Official Title
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A Study to Evaluate the Product Performance of Two Different Designs of Bausch & Lomb PureVision® Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Redesigned Purevision Contact Lens
* Device: 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 adapted wearers of one of the listed contact lenses Subjects must be myopic Subjects must use a lens care system on a regular basis. Exclusion Criteria: Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months. Subjects with any systemic disease affecting ocular health. 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 are using any ocular medication. Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Subjects who have had any corneal surgery (eg, refractive surgery). Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Redesigned Purevision Contact Lens<br>Redesigned Bausch & Lomb PureVision contact lens | Device: Redesigned Purevision Contact Lens<br>* Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.<br>|
| Active Comparator: PureVision Contact Lens<br>Bausch & Lomb PureVision contact lens | Device: PureVision Contact Lens<br>* Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms and Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated. | 1 month | 

Secondary 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). | 1 month | 
| 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. | 1 month | 

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