Clinical Performance of 59% Hioxifilcon A vs. Marketed Hydrogel Contact Lenses in Habitual Hydrogel Wearers

NCT ID: NCT04986644

Last Updated: 2021-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2021-07-19

Brief Summary

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The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.

Detailed Description

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This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial.

The primary outcome variable for this study is overall subjective comfort.

Conditions

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Refractive Error - Myopia Bilateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized cross-over with 1 week of lens wear with each contact lens type.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.

Study Groups

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Test to Moist

1 week of Test DD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.

Group Type EXPERIMENTAL

Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)

Intervention Type DEVICE

Daily disposable contact lens wear for 1 week

Moist to Test

1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test DD contact lenses.

Group Type ACTIVE_COMPARATOR

Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)

Intervention Type DEVICE

Daily disposable contact lens wear for 1 week

Interventions

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Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)

Daily disposable contact lens wear for 1 week

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Currently wearing hydrogel, spherical DD contact lenses at least 5 days/week
* Vision correctable to 20/30 acuity in each eye with spherical DD contact lenses
* No ocular or systemic disease that contra-indicates soft contact lens wear

Exclusion Criteria

* Currently wearing silicone hydrogel DD contact lenses
* Currently wearing 1-DAY ACUVUE® MOIST (comparator) contact lenses
* Currently using rewetting drops with habitual contact lenses
* Vision not correctable to 20/30
* Participating in another clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vision Service Plan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ross Eyecare

Atlanta, Georgia, United States

Site Status

Professional VisionCare

Westerville, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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VS-21-01

Identifier Type: -

Identifier Source: org_study_id

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