Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses

Sponsor

Bausch & Lomb Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT06069609

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

228.3

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), 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, subjects will be dispensed study lenses according to unique randomization tables that will be provided to each Investigator. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: Kalifilcon a Contact Lens for Astigmatism Device: Acuvue Oasys 1-Day for Astigmatism	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 Acuvue Oasys 1-Day for Astigmatism Contact Lenses

Actual Study Start Date :

Aug 11, 2023

Actual Primary Completion Date :

Aug 15, 2023

Actual Study Completion Date :

Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kalifilcon A Contact Lens for Astigmatism	Device: Kalifilcon a Contact Lens for Astigmatism Kalifilcon A Daily Disposable Toric Contact Lens for Astigmatism
Active Comparator: Commercially available contact lenses: Acuvue Oasys 1-Day for Astigmatism	Device: Acuvue Oasys 1-Day for Astigmatism Commercially available contact lenses: Acuvue Oasys 1-Day for Astigmatism

Arm

Intervention/Treatment

Experimental: Kalifilcon A Contact Lens for Astigmatism

Device: Kalifilcon a Contact Lens for Astigmatism

Kalifilcon A Daily Disposable Toric Contact Lens for Astigmatism

Active Comparator: Commercially available contact lenses: Acuvue Oasys 1-Day for Astigmatism

Device: Acuvue Oasys 1-Day for Astigmatism

Commercially available contact lenses: Acuvue Oasys 1-Day for Astigmatism

Outcome Measures

Primary Outcome Measures

Primary gaze orientation for 5 minutes [5 minutes]

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:

The subject is not eligible to participate in the study if the subject is:

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:

NCT06069609

Other Study ID Numbers:

ROC2-23-006

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 6, 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.:

Yes

Additional relevant MeSH terms:

Astigmatism

Study Results

No Results Posted as of Oct 6, 2023