Actively 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
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
Eligibility Criteria
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)
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
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Trial Site Locations
Total: 1 location
1
University of South Florida/Ophthalmology
Tampa, Florida, United States, 33612
Actively Recruiting
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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