Clinical trial NCT04556838: Study of VVN001 Ophthalmic Solution in Dry Eye Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: VivaVision Biotech, Inc
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-masked parallel
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Inferior Corneal Fluorescein Staining
timeFrame: Day 84
Secondary outcomes:
measure: Total Corneal Fluorescein Staining
timeFrame: Day 84
measure: Regional Corneal Fluorescein Staining
timeFrame: Day 84
measure: Eye Dryness
timeFrame: Day 84
Other outcomes:
Locations:
city: Durham
country: United States
facility: Lexitas
state: North Carolina
Study officials:
References:
citation: Tauber J, Evans D, Segal B, Li XY, Shen W, Lu C, Novack GD; VVN001-CS201 Study Group. A phase 2a, double-masked, randomized, vehicle-controlled trial of VVN001 in subjects with dry eye disease. Ocul Surf. 2023 Apr;28:18-24. doi: 10.1016/j.jtos.2022.12.007. Epub 2022 Dec 29.