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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Refractive Error - Myopia Bilateral

Intervention / Treatment
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* Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized cross-over with 1 week of lens wear with each contact lens type.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test to Moist<br>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)<br>* Daily disposable contact lens wear for 1 week<br>|
| Active Comparator: Moist to Test<br>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)<br>* Daily disposable contact lens wear for 1 week<br>|

What is the study measuring?
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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 |