1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: samfilcon A for Presbyopia; Device: kalifilcon A Daily Disposable Multifocal

• Registration Number: NCT05325931
• 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/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-25
• Primary Completion: 2022-03-28
• Study Completion: 2022-03-28
• Status Verified: 2022-04
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-12
• Last Update Submitted: 2022-04-12
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

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

Inclusion Criteria

• Be 40 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.
• 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.
• 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
samfilcon A for Presbyopia	samfilcon A for Presbyopia	B+L ULTRA for Presbyopia Low Add Power (LA) and High Add Power (HA)
kalifilcon A Daily Disposable Multifocal	kalifilcon A Daily Disposable Multifocal	kalifilcon A Daily Disposable Multifocal Low Add Power (LA) and High Add Power (HA)

Primary Outcome Measures

Name	Time	Method
Near Visual Acuity	One week	Mean Binocular logMAR Visual Acuity at Near (40cm)
Visual Acuity	One week	Mean Binocular logMAR Visual Acuity at Distance (6m)

Trial Locations

Locations (1)

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