Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Sponsor

Bausch & Lomb Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT05129124

Collaborator

(none)

Enrollment

Location

Arms

1.4

Actual Duration (Months)

20.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses Device: Commercially available Ultra for Astigmatism Contact Lenses	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Actual Study Start Date :

Nov 30, 2021

Actual Primary Completion Date :

Jan 13, 2022

Actual Study Completion Date :

Jan 13, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T01: +6.00 -2.75 x 180 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T02: +6.00-2.75 x 090 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T03: -3.00-2.75 x180 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T04: -3.00 -2.75 x 090 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T05: -9.00 -2.75 x 180 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T06: -9.00 -2.75 x 090 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T07: -12.00 -2.75 x 180 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T08: -12.00-2.75 x 090 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Active Comparator: C01: +6.00 -2.75 x 180 Commercially available Ultra for Astigmatism Contact Lenses	Device: Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C02: +6.00-2.75 x 090 Commercially available Ultra for Astigmatism Contact Lenses	Device: Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C03: -3.00-2.75 x180 Commercially available Ultra for Astigmatism Contact Lenses	Device: Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C04: -3.00 -2.75 x 090 Commercially available Ultra for Astigmatism Contact Lenses	Device: Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C05: -9.00 -2.75 x 180 Commercially available Ultra for Astigmatism Contact Lenses	Device: Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C06: -9.00 -2.75 x 090 Commercially available Ultra for Astigmatism Contact Lenses	Device: Commercially available Ultra for Astigmatism Contact Lenses Commercially available Ultra for Astigmatism Contact Lenses at different fittings

Outcome Measures

Primary Outcome Measures

Mean Absolute Primary Gaze Orientation at 3 minutes for the lenses inserted at 90 degrees [3 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Considered by the Investigator to not be a suitable candidate for participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch and Lomb Site 01	Rochester	New York	United States	14609

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

Principal Investigator: Jeffery Schafer, OD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT05129124

Other Study ID Numbers:

21-012

First Posted:

Nov 22, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Yes

Additional relevant MeSH terms:

Astigmatism

Study Results

No Results Posted as of Mar 31, 2022