Back to results1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
kalifilcon A Daily Disposable Multifocal
samfilcon A for Presbyopia
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
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.
Sites / Locations
- Bausch site 1
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
kalifilcon A Daily Disposable Multifocal
samfilcon A for Presbyopia
Arm Description
kalifilcon A Daily Disposable Multifocal Low Add Power (LA) and High Add Power (HA)
B+L ULTRA for Presbyopia Low Add Power (LA) and High Add Power (HA)
Outcomes
Primary Outcome Measures
Visual Acuity
Mean Binocular logMAR Visual Acuity at Distance (6m)
Near Visual Acuity
Mean Binocular logMAR Visual Acuity at Near (40cm)
Secondary Outcome Measures
Full Information
NCT ID
NCT05325931
First Posted
April 1, 2022
Last Updated
April 12, 2022
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT05325931
Brief Title
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia
Official Title
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Contact Lenses Compared to Ultra for Presbyopia Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
March 28, 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/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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
kalifilcon A Daily Disposable Multifocal
Arm Type
Experimental
Arm Description
kalifilcon A Daily Disposable Multifocal Low Add Power (LA) and High Add Power (HA)
Arm Title
samfilcon A for Presbyopia
Arm Type
Active Comparator
Arm Description
B+L ULTRA for Presbyopia Low Add Power (LA) and High Add Power (HA)
Intervention Type
Device
Intervention Name(s)
kalifilcon A Daily Disposable Multifocal
Intervention Description
kalifilcon A Daily Disposable Multifocal low add and high
Intervention Type
Device
Intervention Name(s)
samfilcon A for Presbyopia
Intervention Description
Ultra for Presbyopia Low and High Add Contact Lenses
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Mean Binocular logMAR Visual Acuity at Distance (6m)
Time Frame
One week
Title
Near Visual Acuity
Description
Mean Binocular logMAR Visual Acuity at Near (40cm)
Time Frame
One week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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 Daily Disposable Multifocal Compared to Ultra for Presbyopia
We'll reach out to this number within 24 hrs