1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism

Not Applicable

Completed

• Conditions: Myopia; Astigmatism
• Interventions: Device: Ultra for Astigmatism Contact Lenses; Device: kalifilcon A Daily Disposable Toric

• Registration Number: NCT05320042
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Baseline Visit at which informed consent will be obtained and eligibility will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-14
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-11
• Primary Completion: 2022-05-10
• Study Completion: 2022-05-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have the 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.
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
Ultra for Astigmatism Contact Lenses	Ultra for Astigmatism Contact Lenses	Ultra for Astigmatism Contact Lenses
kalifilcon A Daily Disposable Toric	kalifilcon A Daily Disposable Toric	kalifilcon A Daily Disposable Toric

Primary Outcome Measures

Name	Time	Method
Visual Acuity	One week	Mean Binocular logMAR Visual Acuity

Trial Locations

Locations (1)

Bausch site 1; 🇺🇸 Rochester, New York, United States