Study of VVN001 Ophthalmic Solution in Dry Eye Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: VVN001 Ophthalmic Solution 1%
* Drug: VVN001 Ophthalmic Solution 5%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-masked parallel
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VVN001, 1%<br>VVN001, 1% ophthalmic solution | Drug: VVN001 Ophthalmic Solution 1%<br>* VVN001 Ophthalmic Solution 1%<br>|
| Experimental: VVN001, 5%<br>VVN001, 5% ophthalmic solution | Drug: VVN001 Ophthalmic Solution 5%<br>* VVN001 Ophthalmic Solution 5%<br>|
| Placebo Comparator: Vehicle<br>VVN001 Ophthalmic Solution Placebo | Drug: Vehicle<br>* VVN001 Ophthalmic Solution Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inferior Corneal Fluorescein Staining | 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 | 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 | 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 | 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 |