N/A
N=66
Effect of FID 114675A on Lens Wettability
Contact Lens Wettability
Bottom Line
View on ClinicalTrials.gov: NCT01342107 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Lens Wettability — 95.5; 97.0 percentage of lenses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID 114675A multi-purpose disinfecting solution (MPDS) (Device); Soft contact lens (Device); Blister pack solution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Wettability |
95.5; 97.0 | — |
Summary
The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.
Eligibility Criteria
Inclusion Criteria
- 18 years or age or older with normal eyes, other than correction for refractive error.
- At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
- Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
- Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
- Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
- Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
- History or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- Participation in any investigational study within the past 30 days.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01342107). 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.