NCT04986644

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

Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses: Phase 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Vision Service Plan · Industry
• Sex: All
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

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

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

• Refractive Error - Myopia Bilateral

Interventions

Type	Name	Description
DEVICE	Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)	Daily disposable contact lens wear for 1 week

Timeline

• Start date: 2021-05-10
• Primary completion: 2021-07-19
• Completion: 2021-07-19
• First posted: 2021-08-03
• Last updated: 2021-08-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study