Back to results1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism
Primary Purpose
Myopia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
kalifilcon A Daily Disposable Toric
Ultra for Astigmatism Contact Lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Sites / Locations
- Bausch site 1
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
kalifilcon A Daily Disposable Toric
Ultra for Astigmatism Contact Lenses
Arm Description
kalifilcon A Daily Disposable Toric
Ultra for Astigmatism Contact Lenses
Outcomes
Primary Outcome Measures
Visual Acuity
Mean Binocular logMAR Visual Acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT05320042
First Posted
April 1, 2022
Last Updated
November 16, 2022
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT05320042
Brief Title
1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism
Official Title
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Ultra for Astigmatism Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
kalifilcon A Daily Disposable Toric
Arm Type
Experimental
Arm Description
kalifilcon A Daily Disposable Toric
Arm Title
Ultra for Astigmatism Contact Lenses
Arm Type
Active Comparator
Arm Description
Ultra for Astigmatism Contact Lenses
Intervention Type
Device
Intervention Name(s)
kalifilcon A Daily Disposable Toric
Intervention Description
kalifilcon A Daily Disposable Toric
Intervention Type
Device
Intervention Name(s)
Ultra for Astigmatism Contact Lenses
Intervention Description
Ultra for Astigmatism Contact Lenses
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Mean Binocular logMAR Visual Acuity
Time Frame
One week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Steffen
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch site 1
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism
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