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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
- Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. (drug)
- Alternative would be patient exiting the trial and starting on tears or other standard of care. (other)
Sponsor: University of South Florida · Participants: 50 · Started: Apr 6, 2026
Contact the study team
- Pedram Hamrah, MD · Phone: 813-974-0948
- Susan Sherouse · Phone: 813-974-0948
Official record on ClinicalTrials.gov — NCT07502378
Locations in the U.S.
| Florida | University 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.