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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT05325931
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
1
Actual Duration (Months)
29.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: kalifilcon A Daily Disposable Multifocal
  • Device: samfilcon A for Presbyopia
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Contact Lenses Compared to Ultra for Presbyopia Contact Lenses
Actual Study Start Date :
Feb 25, 2022
Actual Primary Completion Date :
Mar 28, 2022
Actual Study Completion Date :
Mar 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity [One week]

    Mean Binocular logMAR Visual Acuity at Distance (6m)

  2. Near Visual Acuity [One week]

    Mean Binocular logMAR Visual Acuity at Near (40cm)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bausch site 1 Rochester New York United States 14609

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Robert Steffen, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT05325931
Other Study ID Numbers:
  • ROC2-22-005
First Posted:
Apr 13, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Presbyopia

Study Results

No Results Posted as of Apr 13, 2022