Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.

Official Title
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Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Hydrogen peroxide-based contact lens solution
* Device: Habitual contact lens solution
* Device: Habitual contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only). Symptoms of contact lens discomfort as defined by the protocol. Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1. Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Extended (over-night) contact lens wearer. Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment. Other protocol-specified 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clear Care<br>Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days | Device: Hydrogen peroxide-based contact lens solution<br> <br> * Other names: Clear Care®;Device: Habitual contact lenses<br>* Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule<br>|
| Active Comparator: Habitual MPS<br>Habitual contact lens solution used with habitual contact lenses for 90 days | Device: Habitual contact lens solution<br>* Biguanide-preserved<br>Device: Habitual contact lenses<br>* Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90 | Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae. | Baseline (Day 0), Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Top 2 Box Percentage Agreement for My Lenses Feel Like New at Day 90 | As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses. | Day 90 | 
| Mean Frequency Score for Symptoms of Grittiness at Day 90 | As interpreted and reported by the subject on a questionnaire. The subject was asked, During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses? and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly). | Day 90 | 
| Mean Frequency Score for Symptoms of Dryness at Day 90 | As reported and interpreted by the subject on a questionnaire. The subject was asked During a typical day in the past 2 weeks, how often did your eyes feel dry? and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly). | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silicone hydrogel contact lenses, Multi-purpose solution, Lid Papillae, Palpebral Roughness