NCT05129072CompletedNot Applicable
Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses
Bausch & Lomb Incorporated1 site in 1 country75 target enrollmentStarted: August 25, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Spherical Aberration Measurement
Study Overview
Brief Summary
This objective of this clinical study aims to confirm whether multiple kalifilcon A daily disposable toric contact lenses are providing the intended level of spherical aberration correction when worn.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 in the opinion of the Investigator.
- •Considered by the Investigator to not be a suitable candidate for participation.
- •A women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: she is currently pregnant, she plans to become pregnant during the study, she is breastfeeding.
Arms & Interventions
kalifilcon A Daily Disposable Toric LD213001 lens
Experimental
kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D
Intervention: kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D (Device)
Outcomes
Primary Outcomes
Spherical Aberration Measurement
Time Frame: 60 minutes
Spherical aberration (SA) occurs when light rays entering at different points of a spherical lens are not focused to the same point of the optical axis.
Secondary Outcomes
- Visibility of Toric Etch Mark by the Investigator(60 minutes)
Investigators
Study Sites (1)
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