Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

Not Applicable

Completed

• Conditions: Refractive Error; Myopia; Astigmatism
• Interventions: Device: OPTI-FREE RepleniSH multipurpose solution; Device: ReNu Biotrue multipurpose solution; Device: Silicone hydrogel contact lenses

• Registration Number: NCT01211535
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-10
• Results First Submitted: 2012-10-15
• Results First Submitted QC: 2012-10-15
• Last Update Submitted: 2012-10-15
• Results First Posted: 2012-11-12
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Currently wearing silicone hydrogel contact lenses on a daily wear basis;
• Currently using OPTI-FREE RepleniSH contact lens solution;
• Generally healthy;
• Normal ocular health;
• Willing to follow study procedures and visit schedule;
• Sign Informed Consent and privacy document;
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Use of additional lens cleaners;
• Known sensitivities to any ingredient in either test article;
• Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
• History of ocular surgery/trauma within the last 6 months;
• Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
• 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 solution	OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
OPTI-FREE RepleniSH	Silicone hydrogel contact lenses	OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
ReNu Biotrue	ReNu Biotrue multipurpose solution	ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
ReNu Biotrue	Silicone hydrogel contact lenses	ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14	Baseline (Day 0), Day 14	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." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.

Trial Locations

Locations (1)

Contact Alcon Trial Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States