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Second plug may boost dry eye comfort

NCT ID NCT07571330

Symptom relief Sponsor: Universidad Autonoma de Nuevo Leon Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether placing a tiny plug in the upper tear duct can further relieve dry eye symptoms in people who already have a plug in the lower tear duct. Researchers will follow 36 adults with aqueous-deficient dry eye for 6 months, measuring eye comfort and tear film changes. The goal is to see if the extra plug helps keep the eye surface more moist.

What this could mean

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

Active substance
punctal plug (a tiny silicone or collagen plug placed in the tear duct opening)
What this could lead to
If it works, this could offer a simple, non-drug way to further improve eye moisture and comfort for people with stubborn dry eye.
What could go wrong
This is a small, early-stage study with only 36 participants. The benefit may be small or not last long, and plugs can sometimes cause irritation or fall out.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

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

Started

Feb 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Patients of both sexes * One or both eyes may be included * Inferior lacrimal punctum occluded (with a punctal plug or cauterization), clinically sealed under slit-lamp examination * Functional superior lacrimal punctum * Aqueous-deficient dry eye (such as Sjögren's disease, graft-versus-host disease, or primary dry eye disease.) * Age \>18 years * OSDI score \>13 and one of the following signs: Tear film markers (Fluorescein tear break up-time \<5, First non-invasive tear breakup time \<10, Schirmer test without anesthesia \<10 mm, Schirmer test with anesthesia \<10 mm), Ocular surface markers (corneal staining \>5 spots or conjunctival staining \>9 spots). Exclusion Criteria: * Active ocular surface infection. * Patients who are unwilling to participate or to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

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

Aqueous-deficient dry eye disease DED

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

  • Ophthalmology Department

    RECRUITING

    Monterrey, Nuevo León, 64460, Mexico

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