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Effect of Acoltremon Ophthalmic Solution 0.003% on Tear Production and Symptoms in Patients With Tear Deficiency and Concurrent Neuropathic Corneal Pain
Sponsor: University of South Florida
Summary
This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production and ocular symptoms in participants with tear deficiency and concurrent neuropathic corneal pain. Acoltremon is formulated to help increase natural tear production by activating TRPM8 (Transient Receptor Potential Melastatin 8) receptors on cold-sensitive corneal nerves. It is thought that this study treatment may help participants by increasing tear production while potentially reducing neuropathic ocular symptoms, including pain and discomfort. Participants will be followed for 8 weeks, evaluating the mean change in unanesthetized Schirmer test score between 3 minutes post-drop at Week 8 compared to pre-drop at baseline (Day 1), change in neuropathic symptom intensity as measured by a 0-10 VAS (Visual Analog Scale) from baseline to Week 8, and change in quality of life as assessed by the Ocular Pain Assessment Survey (OPAS) from baseline to Week 8. The study will also evaluate changes in corneal nerve structure, nerve function, corneal sensitivity, ocular surface symptoms, and treatment satisfaction.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2026-10
Completion Date
2027-06
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
acoltremon ophthalmic solution 0.003%
acoltremon ophthalmic solution 0.003%, one drop, twice a day, into the study eye, for 8 weeks.
Locations (1)
The University of South Florida
Tampa, Florida, United States