Skip to main content
OpenTrials
Completed

NCT Number: NCT04671108

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Refractive Error - Myopia Bilateral

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ross Eyecare, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Daily disposable contact lens wear for 1 week

Primary outcomes

  1. Overall subjective comfort

    Time frame: 1 week after contact lens wear

    Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)

  2. Overall subjective comfort

    Time frame: 2 weeks after contact lens wear

    Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)

Secondary outcomes

  1. End of day subjective comfort

    Time frame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively

    Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)

  2. Subjective vision

    Time frame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively

    Subjective vision rating on a scale of 0 (Not at all sharp/clear) to 10 (Sharp/Clear)

  3. Overall subjective lens preference

    Time frame: Visit 3 - After approximately 2 weeks of contact lens wear

    Forced choice subjective preference for either lens type (1-Day ACUVUE® MOIST or Test DD contact lens) or no preference. i.e. three options presented and participant selects one option.

Sponsors and collaborators

Lead sponsor

Vision Service Plan

Industry

Registry information

Official study title

Comparative Clinical Performance of 59% Hioxifilcon A Daily Disposable Contact Lenses vs. Marketed Daily Disposable Hydrogel Contact Lenses

Acronym: DDHyd

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2020
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.