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

Not Applicable

Completed

• Conditions: Astigmatism

• Registration Number: NCT05129124
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Study Start: 2021-11-30
• Primary Completion: 2022-01-13
• Study Completion: 2022-01-13
• Results First Submitted: 2023-08-31
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Results First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees	3 minutes	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.

Trial Locations

Locations (1)

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