Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.

Official Title
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Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

Conditions
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Myopia, Astigmatism, Refractive Error

Intervention / Treatment
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* Device: OPTI-FREE RepleniSH multipurpose solution
* Device: ReNu Biotrue multipurpose solution
* Device: Silicone hydrogel contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently wearing silicone hydrogel contact lenses on a daily wear basis; Currently using OPTI-FREE RepleniSH contact lens solution; Generally healthy; Normal ocular health; Willing to follow study procedures and visit schedule; Sign Informed Consent and privacy document; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Use of additional lens cleaners; Known sensitivities to any ingredient in either test article; Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study; History of ocular surgery/trauma within the last 6 months; Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study; Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent; 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPTI-FREE RepleniSH<br>OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days | Device: OPTI-FREE RepleniSH multipurpose solution<br>* FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days<br>* Other names: OPTI-FREE® RepleniSH®;Device: Silicone hydrogel contact lenses<br>* Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care<br>|
| Active Comparator: ReNu Biotrue<br>ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days | Device: ReNu Biotrue multipurpose solution<br>* FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days<br>* Other names: ReNu Biotrue™;Device: Silicone hydrogel contact lenses<br>* Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, how your eyes feel right now. A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort. | Baseline (Day 0), Day 14 | 

 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