- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556838
Study of VVN001 Ophthalmic Solution in Dry Eye Disease
December 8, 2023 updated by: VivaVision Biotech, Inc
A Phase 2a, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Safety and Efficacy Activity of 1% and 5% VVN001 Compared to Vehicle in Subjects With Dry Eye Disease
This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and tolerability and to explore the efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
169
Phase
- Phase 2
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
-
-
North Carolina
-
Durham, North Carolina, United States, 27703
- Lexitas
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Provide written informed consent prior to any study-related procedures .
- Are 18 years of age or older.
- Are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study.
- Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) at the screening visit and randomization visit.
- Have a history of dry eye disease in both eyes
- Are currently using artificial tears and have been using within 30 days of the screening visit.
- Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes (0-100 point VAS)
- Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2:
- Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments)
- Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min.
Exclusion Criteria:
- Have a known hypersensitivity or contraindication to the IP or components of IP.
- Have a Schirmer score (without anesthesia) of <1 or >7 mm/5 min in the study eye.
- Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.
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: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VVN001, 1%
VVN001, 1% ophthalmic solution
|
VVN001 Ophthalmic Solution 1%
|
Experimental: VVN001, 5%
VVN001, 5% ophthalmic solution
|
VVN001 Ophthalmic Solution 5%
|
Placebo Comparator: Vehicle
VVN001 Ophthalmic Solution Placebo
|
VVN001 Ophthalmic Solution Vehicle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inferior Corneal Fluorescein Staining
Time Frame: Day 84
|
Mean change from baseline in Inferior corneal fluorescein staining.
Negative number indicates improvement.
Depending upon individual subject's baseline, this measure can range from -4 to +4.
|
Day 84
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Corneal Fluorescein Staining
Time Frame: Day 84
|
Mean change from baseline in total corneal fluorescein staining Negative number indicates improvement.
Depending upon individual subject's baseline, this measure can range from -20 to +20.
|
Day 84
|
Regional Corneal Fluorescein Staining
Time Frame: Day 84
|
Mean change from baseline in temporal regional corneal fluorescein staining.
Negative number indicates improvement.
Depending upon individual subject's baseline, this measure can range from -4 to +4.
|
Day 84
|
Eye Dryness
Time Frame: Day 84
|
Mean Change in Eye Dryness VAS.
Negative number indicates improvement.
Depending upon individual subject's baseline, this measure can range from -100 to +100..
|
Day 84
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
December 3, 2020
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
September 14, 2020
First Submitted That Met QC Criteria
September 14, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VVN001-CS-201
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
Yes
Studies a U.S. FDA-regulated device product
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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