Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Not Applicable
Completed
- Conditions
- Astigmatism
- Interventions
- Device: kalifilcon A Daily Disposable Toric LD213001 Contact LensesDevice: Commercially available Ultra for Astigmatism Contact Lenses
- Registration Number
- NCT05129124
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Have no active ocular disease or allergic conjunctivitis.
- Not be using any topical ocular medications.
- Be willing and able to follow instructions.
- Have signed a statement of informed consent.
Exclusion Criteria
- Participating in a conflicting study.
- Considered by the Investigator to not be a suitable candidate for participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T03: -3.00-2.75 x180 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses T04: -3.00 -2.75 x 090 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses T06: -9.00 -2.75 x 090 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses T01: +6.00 -2.75 x 180 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses T08: -12.00-2.75 x 090 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses C02: +6.00-2.75 x 090 Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses C04: -3.00 -2.75 x 090 Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses C06: -9.00 -2.75 x 090 Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses C03: -3.00-2.75 x180 Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses C01: +6.00 -2.75 x 180 Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses T02: +6.00-2.75 x 090 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses T05: -9.00 -2.75 x 180 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses T07: -12.00 -2.75 x 180 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses C05: -9.00 -2.75 x 180 Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses
- Primary Outcome Measures
Name Time Method Mean Absolute Primary Gaze Orientation at 3 minutes for the lenses inserted at 90 degrees 3 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bausch and Lomb Site 01
🇺🇸Rochester, New York, United States