Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
Not Applicable
Completed
- Conditions
- Myopia
- Registration Number
- NCT00929487
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.
- Detailed Description
This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
Inclusion Criteria
- Have read, understood, signed, and dated the written Informed Consent.
- Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
- Vision correctable to at least 20/30 Snellen.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Topical ocular medication use.
- History of hypersensitivity to any component of the study contact lens care systems.
- Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
- Pregnant, lactating, or planning a pregnancy.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Corneal Staining 2 hours
- Secondary Outcome Measures
Name Time Method Subjective Comfort 2 hours
Trial Locations
- Locations (1)
Visioncare Research, Ltd.
🇬🇧Farnham, Surrey, United Kingdom
Visioncare Research, Ltd.🇬🇧Farnham, Surrey, United Kingdom