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

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.

NCT Number	NCT07659626
Lead Sponsor	The Eye Care Institute Collaborators: Sengi
Conditions	Dry Eye
Enrollment	60 participants
Start Date	2026-07-20
Primary Completion	2027-07-20 (estimated)
Study Completion	2029-07-20 (estimated)
Updated on ClinicalTrials.gov	2026-06-22