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

Not Applicable

Completed

Interventions: Device: Hydrogen peroxide-based contact lens solution
Device: Habitual contact lens solution
Device: Habitual contact lenses

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Clear Care	Hydrogen peroxide-based contact lens solution	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
Clear Care	Habitual contact lenses	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
Habitual MPS	Habitual contact lens solution	Habitual contact lens solution used with habitual contact lenses for 90 days
Habitual MPS	Habitual contact lenses	Habitual contact lens solution used with habitual contact lenses for 90 days

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90	Baseline (Day 0), 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.

Secondary Outcome Measures

Name	Time	Method
Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90	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.
Mean Frequency Score for Symptoms of Grittiness at Day 90	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).
Mean Frequency Score for Symptoms of Dryness at Day 90	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).