Kalifilcon A Toric Compared to Commercially Available Lenses

Bausch & Lomb Incorporated30 enrolled

Overview

Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.

Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Astigmatism

Interventions

Kalifilcon Toric LensDEVICE

Kalifilcon A Daily Disposable Toric for Ametropia

Total1 for AstigmatismDEVICE

Total1 for Astigmatism

Precision1 for AstigmatismDEVICE

Precision1 for Astigmatism

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

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 in the opinion of the Investigator. 2. Considered by the Investigator to not be a suitable candidate for participation

Locations (1)

Bausch & Lomb, Incorporated

Rochester, New York, United States

Outcomes

Primary Outcomes

Primary Gaze Orientation for 5 Minutes

Primary gaze orientation is measured in degrees using a slit lamp and reticule.

Time frame: 5 minutes after lens insertion

Data from ClinicalTrials.gov

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