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

Mar 27, 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

Inclusion Criteria4

Neurotrophic Keratopathy stage 1 diagnosis based on the following: Presence of 3+ fluorescein staining in central cornea and decreased corneal sensation (Cochet-Bonnet less than 4cm in the central cornea)
Baseline unanesthetized Schirmer's test ≤ 10 mm
Females of childbearing potential must have a negative pregnancy test.
Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen \<20/200).

Exclusion Criteria11

Evidence of any active ocular infection or any intraocular inflammation.
Evidence of any persistent epithelial defect/ulcer or any corneal scar/corneal edema.
Presence of any other ocular conditions that require topical medications during the treatment phase.
History of severe systemic allergies or severe ocular allergies.
Inability to suspend topical medications 8 days prior to the starting date and artificial tears 2 hours prior to the first study visit and remain off for the duration of the study.
History of any ocular surgery within three months before study visit 1.
Ocular surgery expected during the duration of the study.
Use of refractive/therapeutic contact lenses during the study period.
Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.
Drug addiction/alcohol abuse.
Participation in another clinical trial concurrently

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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.