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

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: Presbyopia
• Intervention / Treatment: Device: kalifilcon A Daily Disposable Multifocal; Device: samfilcon A for Presbyopia

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: kalifilcon A Daily Disposable Multifocal; kalifilcon A Daily Disposable Multifocal Low Add Power (LA) and High Add Power (HA)	Device: kalifilcon A Daily Disposable Multifocal; kalifilcon A Daily Disposable Multifocal low add and high
ACTIVE_COMPARATOR: samfilcon A for Presbyopia; B+L ULTRA for Presbyopia Low Add Power (LA) and High Add Power (HA)	Device: samfilcon A for Presbyopia; Ultra for Presbyopia Low and High Add Contact Lenses

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

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): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• 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