Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens 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 comfort in soft contact lens wearers.

Official Title
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The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

Conditions
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Contact Lens Wear

Intervention / Treatment
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* Device: OPTI-FREE RepleniSH multipurpose disinfecting solution
* Device: Clear Care contact lens care system
* Device: Contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wear silicone hydrogel contact lenses on a daily wear basis; Currently using OPTI-FREE RepleniSH contact lens solution; Report comfort above 75 on a Visual Analog Scale at the Baseline Visit; Read, sign, and date IRB-approved informed consent and the privacy document; Be generally healthy and have normal ocular health; Be be willing to follow the study procedures and visit schedule; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Use of additional lens cleaners; Known sensitivity to any ingredient in either of the test articles; Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study; Prior (within 7 days of enrollment) or current ocular infections; Clinically significant lash or lid abnormality; History of ocular surgery/trauma within the last 6 months; Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment; Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment; 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 disinfecting solution used with study contact lenses on a daily basis for 2 weeks. | Device: OPTI-FREE RepleniSH multipurpose disinfecting solution<br>* FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.<br>* Other names: OPTI-FREE® RepleniSH®;Device: Contact lenses<br>* Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.<br>|
| Active Comparator: Clear Care<br>Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks. | Device: Clear Care contact lens care system<br>* FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.<br>* Other names: Clear Care®;Device: Contact lenses<br>* Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Ocular Comfort Rating at 2 Weeks | 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. | Baseline (Day 0), 2 weeks | 
| Likert Questionnaire Scores at 2 Weeks | The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft Contact lens, Multi-Purpose Solution, Hydrogen Peroxide