Acoltremon Eye Drops 0.003% for Treating Stage 1 Neurotrophic Keratopathy and Dry Eye Symptoms

What this Trial Is About

Researchers are evaluating how acoltremon ophthalmic solution 0.003% affects tear production in patients with stage 1 neurotrophic keratopathy, a condition where corneal tissue breakdown reduces tear production. The study aims to assess if this treatment can improve wound healing, repair, and nerve function of the cornea, potentially benefiting those with this ocular surface disease. It is a Phase 4, open-label study conducted by the University of South Florida. Participants will receive topical acoltremon 0.003% eye drops twice daily in both eyes for 8 weeks. If both eyes qualify, the eye with worse vision is chosen for study assessments. Those who do not respond well to the treatment may be removed from the trial and receive standard care instead. The study focuses on treatment effects over the 8-week period. During the study, participants will be monitored through tests such as the unanesthetized Schirmer test to measure tear production, corneal staining, and best corrected distance visual acuity. These evaluations occur from baseline day 1 through week 8 to track changes. The primary outcome is the Schirmer test score at 8 weeks. Participants will be followed closely for safety and treatment response throughout the 8 weeks of participation.

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