Can a new eye drop soothe dry, damaged eyes?

NCT ID NCT06360133

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether an experimental eye drop called VVN001 can improve signs and symptoms of dry eye disease in Chinese adults aged 30 to 80. Participants receive either the active drop or a placebo (vehicle) for about 12 weeks. The study measures changes in corneal staining (a sign of eye surface damage) and self-reported eye dryness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VVN001 Ophthalmic Solution, 5% (an experimental eye drop)
What this could lead to
If successful, this could provide a new prescription eye drop to reduce eye surface damage and relieve dryness in people with dry eye disease.
What could go wrong
This is a Phase 3 trial, but results may not confirm benefit or safety. Possible side effects are not detailed, and the effect may vary among individuals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Eye & Ent Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, China

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