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)
30
1
14
1.4
20.8

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
  • 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

  1. 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:
No
Inclusion Criteria:
  1. 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.

  2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.

  3. Have no active ocular disease or allergic conjunctivitis.

  4. Not be using any topical ocular medications.

  5. Be willing and able to follow instructions.

  6. Have signed a statement of informed consent.

Exclusion Criteria:
  1. Participating in a conflicting study.

  2. 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:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022