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

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

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

Study Overview

• Status: Completed
• Conditions: Contact Lens Wear
• Intervention / Treatment: Device: OPTI-FREE RepleniSH multipurpose disinfecting solution; Device: Contact lenses; Device: Clear Care contact lens care system

• Study Type: Interventional
• Enrollment (Actual): 78
• 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:

• 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.

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPTI-FREE RepleniSH; OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Device: OPTI-FREE RepleniSH multipurpose disinfecting solution; FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.; Other Names: OPTI-FREE® RepleniSH®; Device: Contact lenses; Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.
Active Comparator: Clear Care; Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.	Device: Contact lenses; Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.; Device: Clear Care contact lens care system; FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.; Other Names: Clear Care®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Ocular Comfort Rating at 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."	Baseline (Day 0), 2 weeks
Likert Questionnaire Scores at 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.	2 weeks

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 15, 2010
• First Submitted That Met QC Criteria: July 16, 2010
• First Posted (Estimate): July 19, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2012
• Last Update Submitted That Met QC Criteria: September 13, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Hydrogen Peroxide; Soft Contact lens; Multi-Purpose Solution
• Other Study ID Numbers: SMA-09-58