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

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Acuvue Oasys 1-Day for Astigmatism; Device: Kalifilcon a Contact Lens for Astigmatism

• Registration Number: NCT06069609
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-11
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Status Verified: 2023-09
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Commercially available contact lenses: Acuvue Oasys 1-Day for Astigmatism	Acuvue Oasys 1-Day for Astigmatism	-
Kalifilcon A Contact Lens for Astigmatism	Kalifilcon a Contact Lens for Astigmatism	-

Primary Outcome Measures

Name	Time	Method
Primary gaze orientation for 5 minutes	5 minutes

Trial Locations

Locations (1)

Bausch & Lomb, Incorporated; 🇺🇸 Rochester, New York, United States