Acoltremon 0.003% eye drops to improve tears and corneal health in Stage 1 neurotrophic keratopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.