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

NCT ID: NCT04555031

Last Updated: 2021-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2020-09-16

Brief Summary

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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.

Detailed Description

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Conditions

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Habitual Soft Contact Lens Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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kalifilcon A lenses

Group Type EXPERIMENTAL

kalifilcon A lenses

Intervention Type DEVICE

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Dailies Total 1

Group Type ACTIVE_COMPARATOR

Dalies Total 1

Intervention Type DEVICE

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Precision 1

Group Type ACTIVE_COMPARATOR

Precision 1

Intervention Type DEVICE

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Biotrue ONEday

Group Type ACTIVE_COMPARATOR

Biotrue ONEday

Intervention Type DEVICE

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffery Schafer, OD

Role: PRINCIPAL_INVESTIGATOR

Bausch & Lomb Incorporated

Locations

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Bausch and Lomb Site 01

Rochester, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ROC2-20-012

Identifier Type: -

Identifier Source: org_study_id