- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04671108
Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses (DDHyd)
July 21, 2021 updated by: Vision Service Plan
Comparative Clinical Performance of 59% Hioxifilcon A Daily Disposable Contact Lenses vs. Marketed Daily Disposable Hydrogel Contact Lenses
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30324
- Ross Eyecare
-
-
Ohio
-
Westerville, Ohio, United States, 43081
- Professional VisionCare
-
-
Tennessee
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Brentwood, Tennessee, United States, 37027
- Primary Eyecare Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Daily disposable contact lens wear for 1 week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall subjective comfort
Time Frame: 1 week after contact lens wear
|
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
Time Frame: 2 weeks after contact lens wear
|
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
Time Frame: 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)
|
Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
|
Subjective vision
Time Frame: 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)
|
Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
|
Overall subjective lens preference
Time Frame: 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.
|
Visit 3 - After approximately 2 weeks of contact lens wear
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2020
Primary Completion (Actual)
December 18, 2020
Study Completion (Actual)
December 18, 2020
Study Registration Dates
First Submitted
December 7, 2020
First Submitted That Met QC Criteria
December 14, 2020
First Posted (Actual)
December 17, 2020
Study Record Updates
Last Update Posted (Actual)
July 23, 2021
Last Update Submitted That Met QC Criteria
July 21, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VS-20-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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