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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1
University of South Florida/Ophthalmology
Tampa, Florida, United States, 33612