Evaluating a new eye drop for dry eye disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial is a randomized, double-masked, vehicle-controlled study aimed at assessing the safety and efficacy of a 5% VVN001 Ophthalmic Solution in patients suffering from dry eye disease. Conducted in multiple centers, the trial will compare the new treatment against a placebo vehicle in Chinese subjects aged 30 to 80 who have a documented history of dry eye. Participants will be monitored for improvements in eye dryness symptoms and overall eye health throughout the study duration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Eye & Ent Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Xinghuai Sun — Eye & ENT Hospital of Fudan University
• Study coordinator: Caroline Lu
• Email: caroline.lu@vivavisionbio.com
• Phone: 86-18816562189

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.