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NCT06069609 Clinical Trial

Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses

Astigmatism Clinical Trial

Official title:
Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06069609
Other study ID # ROC2-23-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 11, 2023
Est. completion date August 15, 2023

Study information
Verified date September 2023
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double-masked (subject and investigator), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria, subjects will be dispensed study lenses according to unique randomization tables that will be provided to each Investigator. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 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: The subject is not eligible to participate in the study if the subject is: 1. Participating in a conflicting study in the opinion of the Investigator. 2. Considered by the Investigator to not be a suitable candidate for participation.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Kalifilcon a Contact Lens for Astigmatism
Kalifilcon A Daily Disposable Toric Contact Lens for Astigmatism
• Acuvue Oasys 1-Day for Astigmatism
Commercially available contact lenses: Acuvue Oasys 1-Day for Astigmatism

Locations
Country Name City State
United States Bausch & Lomb, Incorporated Rochester New York

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary gaze orientation for 5 minutes 5 minutes
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