N/A
N=104
Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
Myopia · Astigmatism · Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01211535 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 — 87.40; 88.79; 81.75; 83.18 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OPTI-FREE RepleniSH multipurpose solution (Device); ReNu Biotrue multipurpose solution (Device); Silicone hydrogel contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 |
87.40; 88.79; 81.75; 83.18; -5.65; -5.61 | — |
Summary
The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.
Eligibility Criteria
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.
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.
Data sourced from ClinicalTrials.gov (NCT01211535). 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.