Study of A New Contact Lens Cleaning and Disinfecting Solution

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 investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.

Official Title
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Study of A New Contact Lens Cleaning and Disinfecting Solution

Conditions
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Vision Disorders

Intervention / Treatment
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* Device: Investigational Cleaning & Disinfecting Solution
* Device: Clear Care Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be habitual wearers of one of the protocol specified lenses. Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses. Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand. Subjects must agree to wear their lenses on a daily wear basis for approximately three months. Exclusion Criteria: Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution. Subjects who currently wear Opaque Cosmetic Tint Contact Lenses. Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months. Subjects with any systemic disease currently affecting ocular health or which in the Investigators 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 Investigators opinion, affect ocular physiology or lens performance. Subjects with any Present finding during the slit lamp examination that, in the Investigators judgment, interferes with contact lens wear. Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects who are 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Solution<br>Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses. | Device: Investigational Cleaning & Disinfecting Solution<br>* Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution<br>|
| Active Comparator: Clear Care Solution<br>Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses | Device: Clear Care Solution<br>* Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens, Cleaning solution