Status:
COMPLETED
Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
Lead Sponsor:
Alcon Research
Conditions:
Refractive Errors
Eligibility:
All Genders
18+ years
Phase:
NA
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 Biofini...
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 participati...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04789382
Start Date
April 7 2021
End Date
May 7 2021
Last Update
May 25 2022
Active Locations (1)
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1
Alcon Investigator 6565
Maitland, Florida, United States, 32751