Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses (DDHyd)

Vision Service Plan

Status: Completed

Conditions: Refractive Error - Myopia Bilateral

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04671108

VS-20-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Currently wearing 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

• Participating in another clinical trial
• Vision not correctable to 20/30

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Test to Moist

Experimental group

Description:

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

Treatment:

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

Moist to Test

Active Comparator group

Description:

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

Treatment:

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