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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses; Device: Commercially available Ultra for Astigmatism Contact Lenses

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch and Lomb Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

14

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees	Primary gaze orientation is measured in degrees. Measurement Description: Primary gaze is when the patient is looking straight ahead. Orientation refers to how much the contact lens is rotated on the eye. Primary gaze orientation of the contact lens is measured in degrees at the slit-lamp (microscope) using a reticle (protractor). Lens orientation was measured in primary gaze in 5-degree increments. Negative values indicate the contact lens was rotated in the temporal direction. Positive values indicate the contact lens was rotated in the nasal direction. The greater the value (positive or negative) the more the lens is rotated. The absolute value was calculated for all the measurements. The absolute values were used to calculate the mean primary gaze orientation after 3 minutes of contact lens wear. Criteria: P-values ≤0.05 will be considered statistically significant.	3 minutes

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Jeffery Schafer, OD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): January 13, 2022
• Study Completion (Actual): January 13, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 21-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes