The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 78
- Primary Endpoint
- Change From Baseline in Ocular Comfort Rating at 2 Weeks
Study Overview
Brief Summary
The purpose of this study was to assess comfort in soft contact lens wearers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Clear Care
Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Intervention: Clear Care contact lens care system (Device)
Clear Care
Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Intervention: Contact lenses (Device)
OPTI-FREE RepleniSH
OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
Intervention: OPTI-FREE RepleniSH multipurpose disinfecting solution (Device)
OPTI-FREE RepleniSH
OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
Intervention: Contact lenses (Device)
Outcomes
Primary Outcomes
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."
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.
Secondary Outcomes
No secondary outcomes reported