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

Not Applicable

Completed

• Conditions: Contact Lens Wearer
• Interventions: Device: kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D

• Registration Number: NCT05129072
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-25
• Primary Completion: 2021-09-24
• Study Completion: 2021-09-24
• Status Verified: 2021-11
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Last Update Submitted: 2021-11-10
• Study First Posted: 2021-11-22
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
kalifilcon A Daily Disposable Toric LD213001 lens	kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D	kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D

Primary Outcome Measures

Name	Time	Method
Spherical aberration measurement	60 minutes

Secondary Outcome Measures

Name	Time	Method
Visibility of Toric Etch Mark by the Investigator	60 minutes

Trial Locations

Locations (1)

Bausch and Lomb Site 01; 🇺🇸 Rochester, New York, United States