Surface Refractive Index Shift and Lens Absorption/Adsorption of Tear Components of Kalifilcon A Lenses vs Dailies Total1 and Precision1

Bausch + Lomb

Status: Completed

Conditions: Habitual Soft Contact Lens Use

Treatments: Device: Dailies Total1; Device: Kalifon A; Device: Precision1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04840563

ROC2-21-007

Details and patient eligibility

About

Approximately 10 habitual soft contact lens wearing participants will be enrolled in this bilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, participants will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be 18 years or older and have full legal capacity to volunteer.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 3 patient groups

Kalifilcon A lenses

Experimental group

Description:

Commercially available kalifilcon A lenses (Bausch + Lomb)

Treatment:

Device: Kalifon A

Dailies Total1

Active Comparator group

Description:

Dailies Total1 (Alcon)

Treatment:

Device: Dailies Total1

Precision1

Active Comparator group

Description:

Precision1 (Alcon)

Treatment:

Device: Precision1