Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
Not Applicable
Completed
- Conditions
- Astigmatism
- Interventions
- Device: verofilcon A toric contact lenses
- Registration Number
- NCT04464044
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.
- Detailed Description
This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Able to understand and sign an informed consent form;
- Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
- Willing to NOT use rewetting/lubricating drops at any time during the study;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
- History of eye surgery within the previous 12 months, as specified in the protocol;
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- Other protocol-specified exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DDT2 Toric verofilcon A toric contact lenses Verofilcon A toric contact lenses worn in both eyes
- Primary Outcome Measures
Name Time Method Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion Day 1, 10 minutes after lens insertion Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Contact Alcon Call Center for Trial Locations
🇺🇸Fort Worth, Texas, United States