NCT04840563

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

Evaluation of Surface Refractive Index Shift and Lens Absorption / Adsorption of Tear Components of Commercially Available Kalifilcon A Lenses Compared to Dailies Total1 and Precision1

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Habitual Soft Contact Lens Use

Interventions

Type	Name	Description
DEVICE	Kalifon A	Commercially available kalifilcon A lenses
DEVICE	Dailies Total1	Dailies Total1
DEVICE	Precision1	Precision1

Timeline

• Start date: 2021-04-07
• Primary completion: 2021-04-15
• Completion: 2021-04-15
• First posted: 2021-04-12
• Last updated: 2021-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study