New eye drop aims to soothe dry eyes Long-Term
NCT ID NCT07659626
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study tests whether acoltremon eye drops can improve symptoms and tear production in people with dry eye disease over 12 months. Sixty adults will be randomly assigned to receive either the active drug or a standard artificial tear. Researchers will track changes in eye discomfort and tear levels at regular visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acoltremon ophthalmic solution 0.003%
- What this could lead to
- If it works, this could point toward a new treatment option for dry eye disease that improves symptoms and tear production.
- What could go wrong
- This is a small, early-stage study with only 60 participants, so results may not apply to everyone. The control is a standard artificial tear, and the drug may not show significant benefit.
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.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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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.
Who is studied
Subjects aged 18 years or older with a history of dry eye disease (DED) will be randomized.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Male or female, 18 years of age or older at the Screening visit. 2. Have a previous history of DED, clinician diagnosed, or patient reported, within the previous 6 months prior to the Screening visit. 3. Have used, and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit. 4. Both of the following signs of DED in the same eye: 1. Total corneal fluorescein staining score of \>= 2 and \<= 10 based on the NEI grading scheme, with no one region scoring \> 3 in at least 1 eye. 2. Unanesthetized Schirmer test score \>= 2 and \< 10 mm/5 min in at least 1 eye. 3. If both eyes qualify, the eye with the lower baseline Schirmer score will be the study eye (If the Schirmer score is the same, the right eye will be the study eye). 5. Symptomatic defined as an ODS-VAS score of \>=40. 6. Corrected visual acuity equal to or better than 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. 7. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 8. Written informed consent from the subject has been obtained prior to any study related procedures. 9. Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits. Exclusion Criteria: 1. 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. 2. Diagnosis of recurrent, ongoing, or active ocular infection. 3. History of ocular surgery within 1 year prior to the Screening visit. 4. Have had a corneal transplant in either or both eyes. 5. Use of contact lenses within 2 hours of any study visit. 6. Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit. 7. Use of artificial tears within 24 hours of Screening visit. 8. Use of any topical ocular anti-inflammatory medication or dry eye pharmaceuticals within 30 days prior to the Screening visit. 9. Use of any topical ocular glaucoma medication within 30 days prior to the Screening visit. 10. Change in use of any other topical ocular medication within 14 days prior to the Screening visit. 11. Use of medications for the treatment of severe DED and/or Meibomian gland disease within 30 days prior to the Screening visit. 12. Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying less than 14 days prior to the Screening visit. 13. Use of a systemic corticosteroid less than 30 days prior to the Screening visit. 14. Use of a systemic immunomodulator within 30 days prior to the Screening visit. 15. Use of an investigational product or device within 30 days prior to the Screening visit. 16. At the Screening visit, have uncontrolled or severe systemic allergy, rhinitis or sinusitis. 17. History or presence of significant systemic disease. 18. Known allergies or sensitivity to the study interventions or study diagnostic agents. 19. Women of childbearing potential who are not using a medically acceptable form of birth control. 20. The subject has a condition or is in a situation that, in the Investigator's opinion, may put the subject at significant risk.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Butchertown Clinical Trials
RECRUITINGLouisville, Kentucky, 40206, United States
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