N/A
N=40
Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution
Contact Lens Care
Bottom Line
View on ClinicalTrials.gov: NCT00885092 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Mean Ex-Vivo Wetting Angle — 52.1; 59.6 Degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS) (Device); RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®) (Device); Senofilcon A contact lens (ACUVUE® Oasys™) (Device); Balafilcon A contact lens (PureVision®) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ex-Vivo Wetting Angle |
52.1; 59.6 | — |
| SECONDARY Mean Lens Comfort |
4.1; 3.8 | — |
| SECONDARY Percentage of Participants With Solution-Related Corneal Staining |
0; 0 | — |
Summary
The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older.
- Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening).
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening).
- Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline).
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
- Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
- Monocular vision (only one eye with functional vision) or fit with only one contact lens.
- Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
- Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
- Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
- Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
- Corneal staining area assessment ≥ 20% in any corneal region in either eye at screening or baseline visit.
- Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
- Participation in any investigational clinical study within 30 days of baseline visit.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00885092). 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.