Clinical trial NCT00885092: Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution
Official title: Wettability of Silicone Hydrogel Lenses With SiH MPDS FID 114675A vs. A Marketed Multi-Purpose Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Care
Keywords: Contact lenses
Disinfecting solutions
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Primary outcomes:
measure: Mean Ex-Vivo Wetting Angle
timeFrame: Day 7, Hour 14
Secondary outcomes:
measure: Mean Lens Comfort
timeFrame: Day 7, Hour 14
measure: Percentage of Participants With Solution-Related Corneal Staining
timeFrame: Day 7, Hour 14
Other outcomes:
Locations:
Study officials:
References: