Status:

RECRUITING

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

Lead Sponsor:

University of South Florida

Conditions:

Ocular Surface Disease

Neurotrophic Keratopathy Stage 1

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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

Detailed Description

This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production in subjects with stage I neurotrophic keratopathy (NK). The study drug, Acoltremon,...

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

Key Trial Info

Start Date :

March 27 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2027

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07502378

Start Date

March 27 2026

End Date

August 31 2027

Last Update

March 31 2026

Active Locations (1)

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University of South Florida/Ophthalmology

Tampa, Florida, United States, 33612

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