Acoltremon 0.003% eye drops to improve tears and corneal health in Stage 1 neurotrophic keratopathy
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
This study will test whether Acoltremon 0.003% eye drops, used twice daily, can increase tear production and improve corneal signs in people with Stage 1 neurotrophic keratopathy who have low tear production.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT07502378 on ClinicalTrials.gov |
What this trial studies
This interventional Phase 4 trial gives Acoltremon 0.003% ophthalmic solution twice daily in both eyes for eight weeks to adults with Stage 1 neurotrophic keratopathy and tear deficiency. The primary outcome is change in unanesthetized Schirmer test at three minutes from baseline to week 8, with secondary outcomes including change in best-corrected distance visual acuity (ETDRS) and central corneal staining. Eligible participants must have central corneal fluorescein staining, decreased corneal sensation (Cochet-Bonnet <4 cm), and baseline Schirmer ≤10 mm, and must suspend other topical medications before starting. Participants are seen at baseline and through week 8 for efficacy and safety monitoring.
Who should consider this trial
Good fit: Adults with Stage 1 neurotrophic keratopathy who have central corneal staining, reduced corneal sensation, and a baseline unanesthetized Schirmer ≤10 mm who can attend visits in Tampa, Florida are the ideal candidates.
Not a fit: Patients with active ocular infection, persistent epithelial defects or ulcers, corneal scarring or edema, those who need other topical eye medications during treatment, or those with more advanced NK are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, Acoltremon could increase tear production, enhance corneal nerve-related healing, and lower the risk of progression in early neurotrophic keratopathy.
How similar studies have performed: Some nerve-targeting therapies such as recombinant nerve growth factor have shown benefit in neurotrophic keratopathy, but topical tear-stimulating formulations like Acoltremon are relatively novel with limited published data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida
- University of South Florida/Ophthalmology — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Pedram Hamrah, MD — University of South Florida
- Study coordinator: Pedram Hamrah, MD
- Email: phamrah@usf.edu
- Phone: 813-974-0948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.