Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05129072
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arm: 1
• Actual Duration (Days): 30
• Patients Per Site Per Month: 182.6

Study Details

Study Description

Brief Summary

This objective of this clinical study aims to confirm whether multiple kalifilcon A daily disposable toric contact lenses are providing the intended level of spherical aberration correction when worn.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Wearer	Device: kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses
• Actual Study Start Date: Aug 25, 2021
• Actual Primary Completion Date: Sep 24, 2021
• Actual Study Completion Date: Sep 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: kalifilcon A Daily Disposable Toric LD213001 lens kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D	Device: kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D; kalifilcon A Daily Disposable Toric LD213001 lens

Outcome Measures

Primary Outcome Measures

1. Spherical aberration measurement [60 minutes]

Secondary Outcome Measures

1. Visibility of Toric Etch Mark by the Investigator [60 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 in the opinion of the Investigator.

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

3. A women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: she is currently pregnant, she plans to become pregnant during the study, she is breastfeeding.

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: NCT05129072
• Other Study ID Numbers: 21-009
• First Posted: Nov 22, 2021
• Last Update Posted: Nov 22, 2021
• Last Verified: Nov 1, 2021

• 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

Study Results

No Results Posted as of Nov 22, 2021