The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility

Study Overview
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Brief Summary
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The purpose of this study is to more objectively evaluate potential lens-material/care solution bio-incompatibilities. We will do this by measuring corneal staining and the amount of fluorescein dye diffusion into the eye.

Official Title
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The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility

Conditions
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Contact Lens Solution Toxicity

Intervention / Treatment
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* Device: PureVision lenses soaked in ReNu Multiplus
* Device: PureVision lenses soaked in OptiFree RePlenish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age. Best correctable vision to 20/40 in each eye. Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and fluorometry measurement period. No known ocular or systemic allergies, which may interfere with contact lens wear. No known systemic disease, or need for medication that may interfere with contact les wear (i.e. antihistamines, beta-blockers, steroids, ect.). Exclusion Criteria: Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study. Eye (ocular) or systemic allergies that may interfere with contact lens wear. Clinically significant corneal swelling (greater than 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear. Are taking part in any other study or have taken part in a study within the last 14 days. Are pregnant, or anticipating to become pregnant during the course of the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ReNu Multiplus<br>Purevision lenses will be soaked in ReNu Multiplus | Device: PureVision lenses soaked in ReNu Multiplus<br>* Purevision silicone hydrogel lenses<br>|
| Active Comparator: OptiFree RePlenish<br>PureVision lenses will be soaked in OptiFree RePlenish | Device: PureVision lenses soaked in OptiFree RePlenish<br>* Purevision silicone hydrogel lenses soaked in OptiFree RePlenish<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints |  | On day of experiment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining level post lens wear |  | On day of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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staining, toxicity, fluorometry, dye diffusion, anterior chamber