Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
Start Date
3/27/2026
Completion Date
8/31/2027
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, is formulated to help increase tear production. Since the tissue breakdown of the cornea is causing NK, it is thought that this study treatment may help participants with this disease by enhancing wound healing, repair and regeneration through improving nerve function of the cornea. Participants will be followed for 8 weeks, evaluating unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1), their mean change in Best Corrected distance visual acuity (ETDRS standards) from day 1 to week 8, and change in central corneal staining from baseline to week 8.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.
Alternative would be patient exiting the trial and starting on tears or other standard of care.
Conditions
Locations
University of South Florida/Ophthalmology
Tampa, Florida 33612
United States