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

Bausch + Lomb

Status: Completed

Conditions: Presbyopia

Treatments: Device: kalifilcon A Daily Disposable Multifocal; Device: samfilcon A for Presbyopia

Study type: Interventional

Funder types: Industry

Identifiers

NCT05325931

ROC2-22-005

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

kalifilcon A Daily Disposable Multifocal

Experimental group

Description:

kalifilcon A Daily Disposable Multifocal Low Add Power (LA) and High Add Power (HA)

Treatment:

Device: kalifilcon A Daily Disposable Multifocal

samfilcon A for Presbyopia

Active Comparator group

Description:

B+L ULTRA for Presbyopia Low Add Power (LA) and High Add Power (HA)

Treatment:

Device: samfilcon A for Presbyopia