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1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05320042
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
4.5
Anticipated Duration (Months)
9
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/Baseline Visit at which informed consent will be obtained and eligibility will be assessed.

Condition or Disease Intervention/Treatment Phase
  • Device: kalifilcon A Daily Disposable Toric
  • Device: Ultra for Astigmatism Contact Lenses
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Ultra for Astigmatism Contact Lenses
Actual Study Start Date :
Feb 14, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: kalifilcon A Daily Disposable Toric

kalifilcon A Daily Disposable Toric

Device: kalifilcon A Daily Disposable Toric
kalifilcon A Daily Disposable Toric
Active Comparator: Ultra for Astigmatism Contact Lenses

Ultra for Astigmatism Contact Lenses

Device: Ultra for Astigmatism Contact Lenses
Ultra for Astigmatism Contact Lenses

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity [One week]

    Mean Binocular logMAR Visual Acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Be 18 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.

  2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.

  3. Have no active ocular disease or allergic conjunctivitis.

  4. Not be using any topical ocular medications.

  5. Be willing and able to follow instructions.

  6. Have signed a statement of informed consent.

Exclusion Criteria:

  1. Participating in a conflicting study.

  2. 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:
NCT05320042
Other Study ID Numbers:
  • ROC2-21-013
First Posted:
Apr 11, 2022
Last Update Posted:
Apr 15, 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:
Astigmatism

Study Results

No Results Posted as of Apr 15, 2022