Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
NCT ID: NCT05129124
Last Updated: 2025-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-11-30
2022-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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T01: +6.00 -2.75 x 180
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
T02: +6.00-2.75 x 090
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
T03: -3.00-2.75 x180
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
T04: -3.00 -2.75 x 090
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
T05: -9.00 -2.75 x 180
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
T06: -9.00 -2.75 x 090
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
T07: -12.00 -2.75 x 180
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
T08: -12.00-2.75 x 090
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
C01: +6.00 -2.75 x 180
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
C02: +6.00-2.75 x 090
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
C03: -3.00-2.75 x180
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
C04: -3.00 -2.75 x 090
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
C05: -9.00 -2.75 x 180
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
C06: -9.00 -2.75 x 090
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Interventions
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kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Eligibility Criteria
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Inclusion Criteria
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.
Exclusion Criteria
2. Considered by the Investigator to not be a suitable candidate for participation.
18 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffery Schafer, OD
Role: PRINCIPAL_INVESTIGATOR
Bausch & Lomb Incorporated
Locations
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Bausch and Lomb Site 01
Rochester, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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21-012
Identifier Type: -
Identifier Source: org_study_id
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