University of South Florida
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 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 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.
AURORA is a prospective, open-label, single-center, single-arm investigator-initiated study evaluating TRYPTYR (acoltremon ophthalmic solution 0.003%) in 28 adults with neuropathic corneal pain and concurrent tear deficiency. Eligible participants must have neuropathic ocular symptoms for at least 3 months, a driving symptom score of at least 4 on a 0-10 VAS, reduced corneal nerve density and microneuromas on IVCM, at least 50% symptom improvement following topical proparacaine, and an unanesthetized Schirmer score of at least 2 mm but less than 10 mm. Participants will administer acoltremon…
Inclusion Criteria: 1. Male or female aged ≥ 18 years 2. Baseline unanesthetized Schirmer test ≥2 and \< 10 mm 3. Symptoms of neuropathic corneal pain (such as burning, stinging, light sensitivity, discomfort, or pain) for at least 3 months with driving symptom rated at level 4 or higher on VAS. 4. Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, MD): for decreased nerve density AND evidence of microneuromas. 5. Females of childbearing potential must have a negative pregnancy test. 6. Change of 50% or more improvement in VAS score after topical 0.5% proparaca…
acoltremon ophthalmic solution 0.003%, one drop, twice a day, into the study eye, for 8 weeks.
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