Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).

Official Title
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Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

Conditions
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Refractive Error

Intervention / Treatment
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* Device: OPTI-FREE PureMoist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Soft contact lens wear on a daily wear basis Able to wear contact lenses for at least 8 hours Generally healthy and have normal ocular health Other protocol-defined inclusion criteria may apply Exclusion Criteria: No use of additional lens cleaners No known sensitivities to any ingredient in the test article No history of ocular surgery/trauma within the last six months Other protocol-defined exclusion criteria may apply

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPTI-FREE<br>OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen | Device: OPTI-FREE PureMoist<br>* Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 | Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together. | Baseline (Day 0), Day 30 | 
| Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 | Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20. | Baseline (Day 0), Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft contact lenses, Multi-purpose solution, Corneal staining