Kalifilcon A Toric Compared to Commercially Available Lenses

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Precision1 for Astigmatism; Device: Kalifilcon Toric Lens; Device: MyDay Toric; Device: Total1 for Astigmatism

• Registration Number: NCT06098937
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.

Detailed Description

Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), 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 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.

Study Timeline

• Study Start: 2023-09-05
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-27
• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-25
• Results First Submitted: 2024-10-01
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Results First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

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.

Exclusion Criteria

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Precision1 for Astigmatism	Precision1 for Astigmatism	Precision1 for Astigmatism
Kalifilcon A Daily Disposable Toric	Kalifilcon Toric Lens	Kalifilcon A Daily Disposable Toric
MyDay Toric	MyDay Toric	MyDay Toric
Total1 for Astigmatism	Total1 for Astigmatism	Total1 for Astigmatism

Primary Outcome Measures

Name	Time	Method
Primary Gaze Orientation for 5 Minutes	5 minutes after lens insertion	Primary gaze orientation is measured in degrees using a slit lamp and reticule.

Trial Locations

Locations (1)

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