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New eye drops aim to boost tears in dry eye sufferers

NCT ID NCT06544707

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed Phase 3b trial tested AR-15512 eye drops in 81 adults with dry eye disease. The goal was to see if a single dose could quickly increase tear production, measured by tear meniscus height. The study was open-label, meaning everyone knew they were getting the active drug, and results will show how well it works in the short term.

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 (0.003%)
What this could lead to
If successful, this could provide a new eye drop option to quickly increase tear production and relieve dry eye symptoms.
What could go wrong
This is a small, completed Phase 3b study without a placebo group, so results may not prove long-term effectiveness or safety. Dry eye treatments often help some people but not others.

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

81 people

The number who actually took part.

Started

Oct 2024

Finished

Jan 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: * Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported. * Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms. * Corrected visual acuity score of 20/200 or better in both eyes. * 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: * Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration). * History of ocular surgery within 1 year of the Study Visit. * Use of contact lenses in either eye within 7 days of the Study Visit. * Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit. * Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit. * Used artificial tears within 2 hours of the Study Visit. * 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

  • Eye Research Foundation

    Newport Beach, California, 92663, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.