Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
Not Applicable
Completed
- Conditions
- Refractive Errors
- Registration Number
- NCT04254003
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.
- Detailed Description
This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
- Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
- Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
- Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any anterior segment infection, inflammation, or abnormality 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.
- History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
- Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion Day 1, 10 minutes after lens insertion, each product A slit lamp will be used to observe axis orientation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Alcon Investigative Site CT-11
🇺🇸Maitland, Florida, United States
Alcon Investigative Site CT-27
🇺🇸Eden Prairie, Minnesota, United States
Alcon Investigative Site CT-11🇺🇸Maitland, Florida, United States