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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error - Myopia Bilateral
• Intervention / Treatment: Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30324
      • Ross Eyecare
  • Ohio
    • Westerville, Ohio, United States, 43081
      • Professional VisionCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test to Moist; 1 week of Test DD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.	Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA); Daily disposable contact lens wear for 1 week
Active Comparator: Moist to Test; 1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test DD contact lenses.	Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA); Daily disposable contact lens wear for 1 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall subjective comfort	Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)	1 week after contact lens wear
Overall subjective comfort	Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)	2 weeks after contact lens wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End of day subjective comfort	Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)	Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Subjective vision	Subjective vision rating on a scale of 0 (Not at all sharp/clear) to 10 (Sharp/Clear)	Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Overall subjective lens preference	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.	Visit 3 - After approximately 2 weeks of contact lens wear

Collaborators and Investigators

• Sponsor: Vision Service Plan

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): July 19, 2021
• Study Completion (Actual): July 19, 2021

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: VS-21-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No