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

Not Applicable

Completed

• Conditions: Refractive Error - Myopia Bilateral
• Interventions: Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)

• Registration Number: NCT04671108
• Lead Sponsor: Vision Service Plan

Brief 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.

Study Timeline

• Study Start: 2020-11-11
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-17
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test to Moist	Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)	1 week of Test DD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
Moist to Test	Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)	1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test DD contact lenses.

Primary Outcome Measures

Name	Time	Method
Overall subjective comfort	2 weeks after contact lens wear	Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)

Secondary Outcome Measures

Name	Time	Method
Subjective vision	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)
Overall subjective lens preference	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.
End of day subjective comfort	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)

Trial Locations

Locations (3)

Professional VisionCare; 🇺🇸 Westerville, Ohio, United States

Primary Eyecare Group; 🇺🇸 Brentwood, Tennessee, United States

Ross Eyecare; 🇺🇸 Atlanta, Georgia, United States