N/A
N=110
7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers
Contact Lens Care
Bottom Line
View on ClinicalTrials.gov: NCT00884806 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Solution-Related Corneal Staining — 0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS) (Device); Etafilcon A contact lens (ACUVUE® 2™) (Device); Senofilcon A contact lens (ACUVUE® OASYS™) (Device); Lotrafilcon B contact lens (O2 OPTIX®) (Device); Balafilcon A contact lens (PureVision®) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Solution-Related Corneal Staining |
— | — |
| SECONDARY Mean Lens Comfort |
4.4 | — |
Summary
The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older.
- Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit).
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit 1.
- Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit).
- Other protocol-specified 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 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 (NCT00884806). 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.