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NOT YET RECRUITING
NCT07659626

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

Sponsor: The Eye Care Institute

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-07-20

Completion Date

2029-07-20

Last Updated

2026-06-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Acoltremon 0.003%

acoltremon 0.003%

DRUG

Refresh classic preservative free

Refresh classic preservative free (control)

Locations (1)

Butchertown Clinical Trials

Louisville, Kentucky, United States