Actively Recruiting

Phase 3
Age: 30Years - 80Years
All Genders
NCT06360133

Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

Led by VivaVision Biotech, Inc · Updated on 2024-11-20

700

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

Who Can Participate

Age: 30Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 6550 (0-100 point VAS).
  • Have ongoing dry eye disease in the same eye or both eyes, defined by all of the following at Visit 1 and Visit 2: total CFS score 656; any subregion CS score 652.5; Schirmer score (without anesthesia) 651 and 6547 mm/5 min.
  • Have a BCVA in the study eye of 654.3 (Logarithmic Visual Acuity Charts, 5-mark record).
Not Eligible

You will not qualify if you...

  • Known hypersensitivity or contraindication to the investigational product or its components.
  • History of uncontrolled glaucoma, intraocular pressure over 21 mmHg in either eye at screening, or treatment with eye drops for glaucoma in the study eye.
  • Laser or surgery for glaucoma in the study eye within 90 days before the study.
  • Women of childbearing potential who are pregnant, lactating, or preparing for pregnancy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Eye & Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

C

Caroline Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease | DecenTrialz