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.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch and Lomb Site 01

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
Have no active ocular disease or allergic conjunctivitis.
Not be using any topical ocular medications.
Be willing and able to follow instructions.
Have signed a statement of informed consent.

Exclusion criteria

Participating in a conflicting study.
Considered by the Investigator to not be a suitable candidate for participation.

Treatment and study plan

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Device

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

Commercially available Ultra for Astigmatism Contact Lenses

Device

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

Primary outcomes

Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Nov 22, 2021
Registry last updated: Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed