Back to resultsClinical Performance of 59% Hioxifilcon A vs. Marketed Hydrogel Contact Lenses in Habitual Hydrogel Wearers
Primary Purpose
Refractive Error - Myopia Bilateral
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error - Myopia Bilateral
Eligibility Criteria
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
Sites / Locations
- Ross Eyecare
- Professional VisionCare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test to Moist
Moist to Test
Arm Description
1 week of Test DD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test DD contact lenses.
Outcomes
Primary Outcome Measures
Overall subjective comfort
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Overall subjective comfort
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Secondary Outcome Measures
End of day subjective comfort
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Subjective vision
Subjective vision rating on a scale of 0 (Not at all sharp/clear) to 10 (Sharp/Clear)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04986644
Brief Title
Clinical Performance of 59% Hioxifilcon A vs. Marketed Hydrogel Contact Lenses in Habitual Hydrogel Wearers
Official Title
Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses: Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
July 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vision Service Plan
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error - Myopia Bilateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized cross-over with 1 week of lens wear with each contact lens type.
Masking
Investigator
Masking Description
Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test to Moist
Arm Type
Experimental
Arm Description
1 week of Test DD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
Arm Title
Moist to Test
Arm Type
Active Comparator
Arm Description
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test DD contact lenses.
Intervention Type
Device
Intervention Name(s)
Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)
Intervention Description
Daily disposable contact lens wear for 1 week
Primary Outcome Measure Information:
Title
Overall subjective comfort
Description
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Time Frame
1 week after contact lens wear
Title
Overall subjective comfort
Description
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Time Frame
2 weeks after contact lens wear
Secondary Outcome Measure Information:
Title
End of day subjective comfort
Description
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Time Frame
Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Title
Subjective vision
Description
Subjective vision rating on a scale of 0 (Not at all sharp/clear) to 10 (Sharp/Clear)
Time Frame
Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Title
Overall subjective lens preference
Description
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.
Time Frame
Visit 3 - After approximately 2 weeks of contact lens wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ross Eyecare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Facility Name
Professional VisionCare
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Performance of 59% Hioxifilcon A vs. Marketed Hydrogel Contact Lenses in Habitual Hydrogel Wearers
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