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

August 4, 2026 updated by: Bausch & Lomb Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14609
        • Bausch and Lomb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kalifilcon A First, Then samfilcon A for Presbyopia
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
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.
Device: samfilcon A for Presbyopia
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.
Experimental: samfilcon A for Presbyopia First, Then kalifilcon A
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
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.
Device: samfilcon A for Presbyopia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity (Distance)
Time Frame: One week (follow-up visit)
Mean Binocular logMAR Visual Acuity at Distance (6m)
One week (follow-up visit)
Visual Acuity (Near)
Time Frame: One week (follow-up)
Mean Binocular logMAR Visual Acuity at Near (40cm)
One week (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Jeffery Schafer, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2022

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

March 28, 2022

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROC2-22-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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