Study of VVN001 Ophthalmic Solution in Dry Eye Disease

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556838
• Other study ID #: VVN001-CS-201
• Status: Completed
• Phase: Phase 2
• Start date: December 3, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2023
• Source: VivaVision Biotech, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• VVN001 Ophthalmic Solution 1%
VVN001 Ophthalmic Solution 1%
• VVN001 Ophthalmic Solution 5%
VVN001 Ophthalmic Solution 5%
• Vehicle
VVN001 Ophthalmic Solution Vehicle

Locations

Country	Name	City	State
United States	Lexitas	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VivaVision Biotech, Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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