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

• ClinicalTrials.gov Identifier: NCT01164865
• Recruitment Status: Completed
• First Posted: July 19, 2010
• Results First Posted: October 12, 2012
• Last Update Posted: October 12, 2012
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Contact Lens Wear	Device: OPTI-FREE RepleniSH multipurpose disinfecting solution; Device: Clear Care contact lens care system; Device: Contact lenses	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers
• Study Start Date: June 2010
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

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 Name: 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: 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 Name: Clear Care®; 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.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Ocular Comfort Rating at 2 Weeks [ Time Frame: 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."
2. Likert Questionnaire Scores at 2 Weeks [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01164865
• Other Study ID Numbers: SMA-09-58
• First Posted: July 19, 2010
• Results First Posted: October 12, 2012
• Last Update Posted: October 12, 2012
• Last Verified: September 2012

Keywords provided by Alcon Research:

Soft Contact lens; Multi-Purpose Solution; Hydrogen Peroxide