Kalifilcon A Toric Compared to Commercially Available Lenses

Sponsor

Bausch & Lomb Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT06098937

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

41.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Ametropia	Device: Kalifilcon Toric Lens Device: Total1 for Astigmatism Device: Precision1 for Astigmatism Device: MyDay Toric	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:

Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses

Actual Study Start Date :

Sep 5, 2023

Actual Primary Completion Date :

Sep 27, 2023

Actual Study Completion Date :

Sep 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kalifilcon A Daily Disposable Toric Kalifilcon A Daily Disposable Toric	Device: Kalifilcon Toric Lens Kalifilcon A Daily Disposable Toric for Ametropia
Active Comparator: Total1 for Astigmatism Total1 for Astigmatism	Device: Total1 for Astigmatism Total1 for Astigmatism
Active Comparator: Precision1 for Astigmatism Precision1 for Astigmatism	Device: Precision1 for Astigmatism Precision1 for Astigmatism
Active Comparator: MyDay Toric MyDay Toric	Device: MyDay Toric MyDay Toric

Outcome Measures

Primary Outcome Measures

Primary gaze orientation for 5 minutes [5 minutes after lens insertion]
Primary gaze orientation is measured in degrees using a slit lamp and reticule.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb, Incorporated	Rochester	New York	United States	14609

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT06098937

Other Study ID Numbers:

ROC-23-007

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 25, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Refractive Errors

Study Results

No Results Posted as of Oct 25, 2023