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

Bausch & Lomb Incorporated30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Astigmatism

Interventions

kalifilcon A Daily Disposable Toric LD213001 Contact LensesDEVICE

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

Commercially available Ultra for Astigmatism Contact LensesDEVICE

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bausch and Lomb Site 01

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 minutes

Data from ClinicalTrials.gov

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