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

N/ACompletedNCT01996709

Alcon Research142 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

142

Conditions

Refractive Error

Interventions

Hydrogen peroxide-based contact lens solutionDEVICE

Habitual contact lens solutionDEVICE

Biguanide-preserved

Habitual contact lensesDEVICE

Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Day 0), Day 90

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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).

Time frame: Day 90

Data from ClinicalTrials.gov

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