N/A
N=89
Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
Contact Lens Fit · Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01240135 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Lens Fit — 100; 100 percentage of acceptable fit
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID 114675A multi-purpose disinfecting solution (MPDS) (Device); renu fresh Multi-Purpose Solution (MPS) (Device); Galyfilcon A contact lenses (Acuvue Advance) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit |
100; 100 | — |
| SECONDARY Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score |
0.6; 1.4 | — |
Summary
The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older.
- History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
- Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- 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 to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
- History of intolerance or known sensitivity to any component of the treatments.
- Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01240135). 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.