N/A
N=175
Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01484938 ↗Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 — -5.04 Percentage of corneal staining
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OPTI-FREE PureMoist (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 |
-5.04 | — |
| PRIMARY Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 |
-0.82 | — |
Summary
The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Soft contact lens wear on a daily wear basis
- Able to wear contact lenses for at least 8 hours
- Generally healthy and have normal ocular health
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- No use of additional lens cleaners
- No known sensitivities to any ingredient in the test article
- No history of ocular surgery/trauma within the last six months
- Other protocol-defined exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01484938). 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.