N/A
N=68
Effect of an Investigational Multi-Purpose Solution on Lens Moisture
Contact Lens Moisture
Bottom Line
View on ClinicalTrials.gov: NCT01341990 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Mean Ex-Vivo Advancing Contact Angle — 56.7; 59.2 Degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS) (Device); ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS) (Device); Silicone Hydrogel Contact Lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ex-Vivo Advancing Contact Angle |
59.5; 63.4 | — |
| PRIMARY Mean Ex-Vivo Advancing Contact Angle |
59.5; 63.4 | — |
Summary
The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older.
- Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).
- Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.
- Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Known sensitivity or intolerance to contact lens multi-purpose solutions.
- Use of any topical ocular OTC or prescribed topical ocular medications.
- History or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- Medical condition or use of medication that cause ocular side effects.
- Participation in any investigational study within the past 30 days.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01341990). 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.