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

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

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Hydrogen peroxide-based contact lens solution; Device: Habitual contact lenses; Device: Habitual contact lens solution

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Lisa Zoota, MPH, Alcon Research

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Silicone hydrogel contact lenses; Multi-purpose solution; Lid Papillae; Palpebral Roughness
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Pharmaceutical Solutions; Hydrogen Peroxide; Contact Lens Solutions
• Other Study ID Numbers: A01337