NCT04555031

Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

• 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 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, 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, subjects 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	kalifilcon A lenses	Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
DEVICE	Dalies Total 1	Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
DEVICE	Precision 1	Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
DEVICE	Biotrue ONEday	Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Timeline

• Start date: 2020-09-09
• Primary completion: 2020-09-16
• Completion: 2020-09-16
• First posted: 2020-09-18
• Last updated: 2021-11-08
• Results posted: 2021-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study