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RECRUITING
NCT07502378
PHASE4

Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency

Sponsor: University of South Florida

View on ClinicalTrials.gov

Summary

STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-03-27

Completion Date

2027-08-31

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.

This is an FDA approved drug. The participants will be educated on the potential instillation site sensation that may occur as reported from the Pivotal Trials and that the sensation may differ between eyes due to the Neurotrophic Keratopathy. Qualified eyes must meet the inclusion and exclusion criteria. If both eyes qualify, then the one with the worst vision will be the study eye. If both eyes have equal visual acuity then the right eye will be the study eye.

OTHER

Alternative would be patient exiting the trial and starting on tears or other standard of care.

This is an open label trial. If the patient does not do well on Acoltremon Ophthalmic Solution, then the participant will be removed from trial and put on standard of care treatment, other than Acoltremon.

Locations (1)

University of South Florida/Ophthalmology

Tampa, Florida, United States