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

NCT05325931 | Completed Results FDA Device

• 1 other identifier: ROC2-22-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

• Visual Acuity (Distance)

  Mean Binocular logMAR Visual Acuity at Distance (6m)

  One week (follow-up visit)

• Visual Acuity (Near)

  Mean Binocular logMAR Visual Acuity at Near (40cm)

  One week (follow-up)

Study Arms (2)

kalifilcon A First, Then samfilcon A for Presbyopia

EXPERIMENTAL

Participants wore kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable, for approximately 1 week.

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

samfilcon A for Presbyopia First, Then kalifilcon A

EXPERIMENTAL

Participants wore Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable, for approximately 1 week.

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

Interventions

kalifilcon A Daily Disposable Multifocal DEVICE

kalifilcon A Daily Disposable Multifocal contact lenses (Low Add \[LD191001\] and High Add \[LD191002\] designs), worn bilaterally on a daily-disposable, single-use basis (≥8 hours/day) for approximately 1 week.

kalifilcon A First, Then samfilcon A for Presbyopia; samfilcon A for Presbyopia First, Then kalifilcon A

samfilcon A for Presbyopia DEVICE

Ultra for Presbyopia (samfilcon A) Low and High Add contact lenses, worn bilaterally on a daily-disposable, single-use basis (≥8 hours/day) for approximately 1 week.

kalifilcon A First, Then samfilcon A for Presbyopia; samfilcon A for Presbyopia First, Then kalifilcon A

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participating in a conflicting study.
• Considered by the Investigator to not be a suitable candidate for participation.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch and Lomb

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

single-site

Results Point of Contact

• Title: Jeffery Schafer, Director Clinical Research
• Organization: Bausch + Lomb

jeffery.schafer@bausch.com

5856032402

Study Officials

• Jeffery Schafer

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants wore each type of contact lens in a random order for approximately 1 week.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 13, 2022
• Study Start: February 25, 2022
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: August 6, 2026
• Results First Posted: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)