1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism

Bausch + Lomb

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: Ultra for Astigmatism Contact Lenses; Device: kalifilcon A Daily Disposable Toric

Study type: Interventional

Funder types: Industry

Identifiers

NCT05320042

ROC2-21-013

Details and patient eligibility

About

Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Baseline Visit at which informed consent will be obtained and eligibility will be assessed.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have the 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups

kalifilcon A Daily Disposable Toric

Experimental group

Description:

kalifilcon A Daily Disposable Toric

Treatment:

Device: kalifilcon A Daily Disposable Toric

Ultra for Astigmatism Contact Lenses

Active Comparator group

Description:

Ultra for Astigmatism Contact Lenses

Treatment:

Device: Ultra for Astigmatism Contact Lenses