Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
- Conditions
- Refractive Errors
- Registration Number
- NCT04789382
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.
- Detailed Description
Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Understand and sign an Informed Consent;
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Manifest cylinder of less than or equal to 1.50 diopter (D) in each eye;
- Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;
- Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.
- Other protocol-specified inclusion criteria may apply.
Key
- Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Eye surgery, as specified in the protocol;
- Dry eye; use of artificial tears, as specified in the protocol;
- Other protocol-specified exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Average Percent Area of Corneal Staining Hour 2 (each wear period) A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alcon Investigator 6565
🇺🇸Maitland, Florida, United States
Alcon Investigator 6565🇺🇸Maitland, Florida, United States