RecruitingNCT07659626

Long-term Effects of Acoltremon vs. Control in Dry Eye Disease

A Randomized, Investigator-masked, Longitudinal Study Evaluating Long-term Changes in Symptoms and Tear Production of Acoltremon Ophthalmic Solution 0.003% Compared to Control in Subjects With Dry Eye Disease


Sponsor

The Eye Care Institute

Enrollment

60 participants

Start Date

Aug 18, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Acoltremon 0.003% and a drug called Refresh classic preservative free for people with dry eye. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcoltremon 0.003%

acoltremon 0.003%

DRUGRefresh classic preservative free

Refresh classic preservative free (control)


Locations(1)

Butchertown Clinical Trials

Louisville, Kentucky, United States

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NCT07659626


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