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

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.

Study Overview

• Status: Completed
• Conditions: Habitual Soft Contact Lens Use
• Intervention / Treatment: Device: kalifilcon A lenses; Device: Dalies Total 1; Device: Precision 1; Device: Biotrue ONEday

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch and Lomb Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older and have full legal capacity to volunteer.
• Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• No active ocular disease or allergic conjunctivitis.
• Not using any topical ocular medications.
• Willing and able to follow instructions.
• Signed a statement of informed consent.

Exclusion Criteria:

• Participating in a conflicting study in the opinion of the Investigator.
• Considered by the Investigator to not be a suitable candidate for participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: kalifilcon A lenses	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.
Active Comparator: Dailies Total 1	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.
Active Comparator: Precision 1	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.
Active Comparator: Biotrue ONEday	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface Refractive Index Shifts at 5 Minutes	Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.	5 minutes
Surface Refractive Index Shifts at 10 Minutes	Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.	10 minutes
Surface Refractive Index Shifts at 15 Minutes	Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.	15 minutes

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): September 16, 2020
• Study Completion (Actual): September 16, 2020

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ROC2-20-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No