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

NCT04840563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-07-22

No results posted yet for this study

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

DEVICE

Kalifon A

Commercially available kalifilcon A lenses

DEVICE

Dailies Total1

Dailies Total1

DEVICE

Precision1

Precision1

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Jeffery Schafer, OD · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2021-04-15
Completion
2021-04-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840563 on ClinicalTrials.gov