Back to resultsKalifilcon A Toric Compared to Commercially Available Lenses
Primary Purpose
Refractive Ametropia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kalifilcon Toric Lens
Total1 for Astigmatism
Precision1 for Astigmatism
MyDay Toric
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Ametropia
Eligibility Criteria
Inclusion Criteria: Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have 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 in the opinion of the Investigator. Considered by the Investigator to not be a suitable candidate for participation
Sites / Locations
- Bausch & Lomb, Incorporated
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Kalifilcon A Daily Disposable Toric
Total1 for Astigmatism
Precision1 for Astigmatism
MyDay Toric
Arm Description
Kalifilcon A Daily Disposable Toric
Total1 for Astigmatism
Precision1 for Astigmatism
MyDay Toric
Outcomes
Primary Outcome Measures
Primary gaze orientation for 5 minutes
Primary gaze orientation is measured in degrees using a slit lamp and reticule.
Secondary Outcome Measures
Full Information
NCT ID
NCT06098937
First Posted
September 29, 2023
Last Updated
October 23, 2023
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT06098937
Brief Title
Kalifilcon A Toric Compared to Commercially Available Lenses
Official Title
Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
September 27, 2023 (Actual)
Study Completion Date
September 27, 2023 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion 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 have study lenses inserted in random, successive order according to unique randomization schedules that will be provided to each Investigator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Ametropia
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 Toric
Arm Type
Experimental
Arm Description
Kalifilcon A Daily Disposable Toric
Arm Title
Total1 for Astigmatism
Arm Type
Active Comparator
Arm Description
Total1 for Astigmatism
Arm Title
Precision1 for Astigmatism
Arm Type
Active Comparator
Arm Description
Precision1 for Astigmatism
Arm Title
MyDay Toric
Arm Type
Active Comparator
Arm Description
MyDay Toric
Intervention Type
Device
Intervention Name(s)
Kalifilcon Toric Lens
Intervention Description
Kalifilcon A Daily Disposable Toric for Ametropia
Intervention Type
Device
Intervention Name(s)
Total1 for Astigmatism
Intervention Description
Total1 for Astigmatism
Intervention Type
Device
Intervention Name(s)
Precision1 for Astigmatism
Intervention Description
Precision1 for Astigmatism
Intervention Type
Device
Intervention Name(s)
MyDay Toric
Intervention Description
MyDay Toric
Primary Outcome Measure Information:
Title
Primary gaze orientation for 5 minutes
Description
Primary gaze orientation is measured in degrees using a slit lamp and reticule.
Time Frame
5 minutes after lens insertion
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 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 in the opinion of the Investigator.
Considered by the Investigator to not be a suitable candidate for participation
Facility Information:
Facility Name
Bausch & Lomb, Incorporated
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
Kalifilcon A Toric Compared to Commercially Available Lenses
We'll reach out to this number within 24 hrs