Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07502378

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

Led by University of South Florida · Updated on 2026-03-31

50

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Stage 1 Neurotrophic Keratopathy with 3+ fluorescein staining in central cornea and decreased corneal sensation (less than 4 cm) in the central cornea
  • Baseline unanesthetized Schirmer's test 10 mm or less
  • Females of childbearing potential must have a negative pregnancy test
  • Best corrected distance visual acuity in the study eye of at least +1.0 Log MAR (better than 20/200)
Not Eligible

You will not qualify if you...

  • Any active ocular infection or intraocular inflammation
  • Persistent epithelial defect, corneal ulcer, corneal scar, or corneal edema
  • Other ocular conditions requiring topical medications during treatment
  • History of severe systemic or ocular allergies
  • Inability to stop topical medications 8 days before starting and artificial tears 2 hours before first visit and throughout study
  • Ocular surgery within 3 months before study or expected during study
  • Use of refractive or therapeutic contact lenses during study
  • Pregnancy, breastfeeding, or intent to become pregnant during treatment
  • Drug addiction or alcohol abuse
  • Participation in another clinical trial at the same time

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of South Florida/Ophthalmology

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

P

Pedram Hamrah, MD

CONTACT

S

Susan Sherouse

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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