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New eye drops aim to restore natural moisture in dry eyes

NCT ID NCT06544694

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new eye drop called AR-15512 can improve the health of the eye surface in people with dry eye disease. 80 participants received either the new drops or artificial tears. The main goal was to see if the drops increased the number of goblet cells, which help keep the eye lubricated. The study is complete, but results are not yet available.

What this could mean

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

Active substance
AR-15512 ophthalmic solution (also called TRYPTYR or Acoltremon)
What this could lead to
If successful, this could lead to a new eye drop that helps restore the eye's natural moisture layer, offering better relief for dry eye disease.
What could go wrong
This is a small, completed Phase 3b study focused on a specific cell count, not symptoms. The treatment may not improve how patients feel, and results may not apply to all dry eye patients.

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

80 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2025

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

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.

Key Inclusion Criteria: * Have a previous history of DED, clinician diagnosed or patient reported, within the previous 6 months prior to the Screening visit. * Have used artificial tears for DED symptoms within 2 months prior to the Screening visit. * Corrected visual acuity equal to or better than logarithm Minimum angle of reflection (logMar) +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at both the Screening and Baseline visits. * Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history. * Other protocol specified inclusion criteria may apply. Key Exclusion Criteria: * History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety. * Current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation. * History of ocular surgery within 1 year prior to the Screening visit; history of corneal transplant in one or both eyes. * Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study. * Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14 days prior to the Screening visit or any planned use during the study. * Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study. * Other protocol-specified exclusion criteria may apply.

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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.

Contacts and locations

Locations

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206, United States

  • CORE, Inc.

    Shelby, North Carolina, 28150, United States

  • Oculus Research

    Garner, North Carolina, 27529, United States

  • Wilmington Eye

    Leland, North Carolina, 28451, United States

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