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

Not Applicable

Completed

• Conditions: Contact Lens Wear
• Interventions: Device: OPTI-FREE RepleniSH multipurpose disinfecting solution; Device: Clear Care contact lens care system; Device: Contact lenses

• Registration Number: NCT01164865
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to assess comfort in soft contact lens wearers.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-19
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-09
• Results First Submitted: 2012-09-13
• Results First Submitted QC: 2012-09-13
• Last Update Submitted: 2012-09-13
• Results First Posted: 2012-10-12
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPTI-FREE RepleniSH	OPTI-FREE RepleniSH multipurpose disinfecting solution	OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
OPTI-FREE RepleniSH	Contact lenses	OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
Clear Care	Contact lenses	Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Clear Care	Clear Care contact lens care system	Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Ocular Comfort Rating at 2 Weeks	Baseline (Day 0), 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."
Likert Questionnaire Scores at 2 Weeks	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.