RecruitingPhase 4NCT07502378

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

Enrollment

50 participants

Start Date

Apr 6, 2026

Study Type

INTERVENTIONAL

Conditions

Ocular Surface Disease Neurotrophic Keratopathy Stage 1

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Alternative would be patient exiting the trial and starting on tears or other standard of care. and a drug called Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. for people with neurotrophic keratopathy stage 1 and ocular surface disease. 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

DRUGPatients 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.

OTHERAlternative 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

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NCT07502378

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