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New eye drops aim to soothe dry eye sufferers

NCT ID NCT07281950

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests acoltremon eye drops in 60 adults with dry eye disease to see if they improve symptoms like discomfort and blurry vision. Participants will complete surveys over three months to track changes. The goal is to understand how well the drops work in everyday life for people who still have symptoms despite other treatments.

What this could mean

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

Active substance
acoltremon 0.003% eye drops
What this could lead to
If successful, this could provide a new option to relieve dry eye symptoms for people who still have discomfort despite current treatments.
What could go wrong
This is a small, early-phase study with only 60 participants and no comparison group, so results may not apply broadly. The treatment may not work better than existing options.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

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

Accepted

You do not need to have the condition being studied to take part.

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: * Male or female adults age 18 and older at Visit 1 * Have a previous history of dry eye disease, clinician diagnosed or self-reported, for at least 3 months * Total SPEED score ≥ 6 on SPEED questionnaire at Visit 1 Screening \& Baseline Exclusion Criteria: * History of ocular surgery (excluding LASIK or PRK) in the past 3 months * History of LASIK or PRK in the past 12 months * Initiation, discontinuation or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) less than 14 days prior to Visit 1 or a change in dosage is anticipated during the study. o Note: occasional short-term use of medications such as systemic antihistamines will be permitted provided that use was not within 24 hours of Visit 1 or anticipated use within 24 hours of any study visit. * Active ocular infection or inflammation unrelated to dry eye disease (e.g., uveitis, blepharitis requiring antibiotics). * Use of Restasis, Xiidra, Miebo, or any other topical anti-inflammatory medications within 30 days of Visit 1 and for the duration of the study. * Use of varenicline nasal spray within 30 days of Visit 1 and for the duration of the study. * Eyelid hygiene (such as "lid scrubs") is allowed but should be continued without change to current regiment at Visit 1 Baseline for the duration of the study. * Use of other DED medications within 30 days of Visit 1 Baseline Use of artificial tears is allowed but must be preservative free and the dosing should not change from current regiment at Visit 1 Baseline. * Use of amniotic membranes or serum tears within 90 days of Visit 1 Baseline * Use of lid heating therapy (i.e., LipiFlow, iLUX, TearCare) within 90 days of Visit 1 Baseline and for the duration of the study. * Punctal or intracanalicular plug inserted in either eyelid within 90 days prior to Visit 1 Baseline or anticipated plug insertion or occlusion at any time during the study. * Current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension) or other disease the investigator believes may interfere with study findings or interpretation. * Use of any topical ocular glaucoma medication within 30 days prior to the Screening visit or anticipated use during the study. * Use of systemic medications that affect tear production (e.g., isotretinoin, antihistamines) unless on stable doses for \> 30 days. * Severe ocular surface disease or damage (e.g., corneal ulcers, neurotrophic keratopathy). * Have had a corneal transplant in either or both eyes. * Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study and unwilling to discontinue use during the duration of the study. * Known allergy or hypersensitivity to acoltremon or formulation ingredients. * Current pregnancy or breastfeeding * Women of childbearing potential who are not using an acceptable means of contraception. Acceptable means of contraception include hormonal contraceptives (i.e. oral, implantable, injectable, or transdermal contraceptives, with a barrier such as a diaphragm or a condom) or intrauterine devices. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.

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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

  • Center for Sight

    Las Vegas, Nevada, 89128, United States

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