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New eye drop could offer relief for dry eye sufferers unhappy with restasis

NCT ID NCT07267299

Symptom relief Sponsor: Southern College of Optometry Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether switching from Restasis to a new eye drop called acoltremon 0.003% can better relieve dry eye symptoms and improve tear production. About 100 adults with chronic dry eye who are dissatisfied with Restasis will take part. Researchers will measure changes in tear production and symptom scores over 28 days.

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 offer a more effective option for people with chronic dry eye who are not satisfied with Restasis.
What could go wrong
This is a small, early-phase trial with only 100 participants and a short 28-day follow-up. Results may not apply to all dry eye patients, and the improvement may be modest.

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 100 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

May 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 to 100 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: * Adults ≥18 years of age. * Have a history of DED for at least the past 6 months. * Are currently using Restasis as directed by their eye care provider for ≥1 month. * Participant intends to stop Restasis in the near future because and expressed dissatisfaction with effectiveness of Restasis in reducing dry eye symptoms.. * Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score \[≥2 to \<10 mm/5 min\]) at Screening/Baseline. * Have corrected distance visual acuity of 20/100 or better. * Willing to discontinue contact lens wear throughout the study. Exclusion Criteria: * Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome). * Have a history of ocular surgery within the past 12 months. * Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related. * Punctal plugs in place for \< 3 months and/or Lacrifill in place for \> 5 months. * Have ever used Accutane or are currently using ocular medications (must washout from all dry eye medications/treatments at least 1 week before entry, except for Restasis). * Use of artificial tears within 2 hours prior to the baseline visit or during the study. * Are pregnant or breast feeding. * Have had a physical meibomian gland treatment withing 1 month of enrollment. * Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome eye disorder

As listed by the trial registrant

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

Chronic dry eye Dry eye Eye diseases

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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