Long-term Effects of Acoltremon vs. Control in Dry Eye Disease (NCT07659626) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Long-term Effects of Acoltremon vs. Control in Dry Eye Disease
United States60 participantsStarted 2026-07-20
Plain-language summary
This is a prospective, longitudinal, single-center study designed to evaluate the long-term changes in symptoms and tear production in subjects with dry eye disease. The study is randomized and investigator-masked, with subjects assigned to either the TRYPTYR (Acoltremon ophthalmic solution 0.003%) arm or the control arm (Refresh Classic Preservative-free). The study will be conducted at a single site, with subjects undergoing assessments at baseline and at months 1, 3, 6, 9, and 12.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, 18 years of age or older at the Screening visit.
. Have a previous history of DED, clinician diagnosed, or patient reported, within the previous 6 months prior to the Screening visit.
. Have used, and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit.
. Both of the following signs of DED in the same eye:
. 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.
. Unanesthetized Schirmer test score \>= 2 and \< 10 mm/5 min in at least 1 eye.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Symptomatic defined as an ODS-VAS score of \>=40.
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.
. Diagnosis of recurrent, ongoing, or active ocular infection.
. History of ocular surgery within 1 year prior to the Screening visit.
. Have had a corneal transplant in either or both eyes.
. Use of contact lenses within 2 hours of any study visit.
. Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit.
. Use of artificial tears within 24 hours of Screening visit.
. Use of any topical ocular anti-inflammatory medication or dry eye pharmaceuticals within 30 days prior to the Screening visit.