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

Not Applicable

Completed

• Conditions: Habitual Soft Contact Lens Use
• Interventions: Device: Kalifon A; Device: Precision1; Device: Dailies Total1

• Registration Number: NCT04840563
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-07
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Kalifilcon A lenses	Kalifon A	Commercially available kalifilcon A lenses (Bausch + Lomb)
Precision1	Precision1	Precision1 (Alcon)
Dailies Total1	Dailies Total1	Dailies Total1 (Alcon)

Primary Outcome Measures

Name	Time	Method
Surface refractive index shifts	10 minutes	Immediately following lens removal, the right eye worn lenses for each subject will be measured for surface refractive index on the refractometer.

Trial Locations

Locations (1)

Bausch Site 001; 🇺🇸 Rochester, New York, United States