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

RecruitingPhase 4

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

About the study

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

What is being tested

Sponsor: University of South Florida · Participants: 50 · Started: Apr 6, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07502378

Locations in the U.S.

FloridaUniversity of South Florida/Ophthalmology, Tampa

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.