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

Sponsor

Vision Service Plan (Industry)

Overall Status

Completed

CT.gov ID

NCT04986644

Collaborator

(none)

Enrollment

Locations

Arms

2.3

Actual Duration (Months)

13.5

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error - Myopia Bilateral	Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized cross-over with 1 week of lens wear with each contact lens type.Randomized cross-over with 1 week of lens wear with each contact lens type.

Masking:

Single (Investigator)

Masking Description:

Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 10, 2021

Actual Primary Completion Date :

Jul 19, 2021

Actual Study Completion Date :

Jul 19, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall subjective comfort [1 week after contact lens wear]
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
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

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)
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ross Eyecare	Atlanta	Georgia	United States	30324
2	Professional VisionCare	Westerville	Ohio	United States	43081

Sponsors and Collaborators

Vision Service Plan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vision Service Plan

ClinicalTrials.gov Identifier:

NCT04986644

Other Study ID Numbers:

VS-21-01

First Posted:

Aug 3, 2021

Last Update Posted:

Aug 11, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Refractive Errors

Hyaluronic Acid

Study Results

No Results Posted as of Aug 11, 2021