NCT05325931

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	kalifilcon A Daily Disposable Multifocal	kalifilcon A Daily Disposable Multifocal low add and high
DEVICE	samfilcon A for Presbyopia	Ultra for Presbyopia Low and High Add Contact Lenses

Timeline

• Start date: 2022-02-25
• Primary completion: 2022-03-28
• Completion: 2022-03-28
• First posted: 2022-04-13
• Last updated: 2022-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study