N/A
N=78
Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers
Contact Lens Wear
Bottom Line
View on ClinicalTrials.gov: NCT01164865 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Change From Baseline in Ocular Comfort Rating at 2 Weeks — -8.20; -7.14 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OPTI-FREE RepleniSH multipurpose disinfecting solution (Device); Clear Care contact lens care system (Device); Contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Comfort Rating at 2 Weeks |
-8.20; -7.14 | — |
| PRIMARY Likert Questionnaire Scores at 2 Weeks |
4.20; 4.24; 3.60; 3.69; 4.00; 3.66 | — |
Summary
The purpose of this study was to assess comfort in soft contact lens wearers.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01164865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.