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

NCT07659626 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

  • Dry Eye

Interventions

DRUG

Acoltremon 0.003%

acoltremon 0.003%

DRUG

Refresh classic preservative free

Refresh classic preservative free (control)

Sponsors & Collaborators

  • Sengi

    collaborator INDUSTRY

  • The Eye Care Institute

    lead OTHER

Principal Investigators

  • Guruprasad Pattar, MD, PhD · Butchertown Clinical Trials

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-18
Primary Completion
2027-07-20
Completion
2029-07-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07659626 on ClinicalTrials.gov