Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

Dry Eye Clinical Trial

Official title:

A Phase 3, Randomized, Double-Masked, Vehicle-controlled, Multi-center Study Evaluating the Safety and Efficacy of 5% VVN001 in Chinese Subjects With Dry Eye Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360133
• Other study ID #: VVN001-CCS-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: VivaVision Biotech, Inc
• Contact: Caroline Lu
• Phone: 86-18816562189
• Email: caroline.lu[@]vivavisionbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Provided written informed consent prior to any study-related procedures.

• Are between 30 and 80 years of age.

• Have a history of dry eye disease in both eyes.

• Have been using artificial tears within 30 days of the screening visit

• Have an Eye dryness score =50 (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: 1) total CFS (tCFS) score =6; 2) any subregion CS score =2.5; 3) Schirmer score (without anesthesia) =1 and =7 mm/5 min.

• Have a BCVA in the study eye of =4.3 (Standard for Logarithmic Visual Acuity Charts, 5-mark record).

Exclusion Criteria:

• Have a known hypersensitivity or contraindication to the IP or components of IP.

• 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.

• Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Eye & Ent Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
VivaVision Biotech, Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Fluorescein Staining	Mean Change from baseline (Visit 2) to Day84 (Visit 6) in total corneal fluorescein staining (tCFS) using modified NEI/Industry Workshop (0-4 scale, using 0.5 unit increments).	Day 84
Secondary	Eye Dryness	Mean Change from baseline (Visit 2) to Day 84 (Visit 6) in the individual symptom of eye dryness (0~100 VAS scale).	Day 84