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

Refractive Error - Myopia Bilateral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04986644
• Other study ID #: VS-21-01
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: July 19, 2021

Study information

• Verified date: August 2021
• Source: Vision Service Plan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 19, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractive Error - Myopia Bilateral
• Refractive Errors

Intervention

Device:
• Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)
Daily disposable contact lens wear for 1 week

Locations

Country	Name	City	State
United States	Ross Eyecare	Atlanta	Georgia
United States	Professional VisionCare	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Vision Service Plan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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