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.
Male or female aged ≥ 18 years
Baseline unanesthetized Schirmer test ≥2 and < 10 mm
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.
Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, MD): for decreased nerve density AND evidence of microneuromas.
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.
Single group
acoltremon ophthalmic solution 0.003%
Drugacoltremon ophthalmic solution 0.003%, one drop, twice a day, into the study eye, for 8 weeks.
Change in Unanesthetized Schirmer Test Score at Week 8
Mean change from the pre-dose measurement at baseline (Day 1) to the measurement taken 3 minutes after dosing at Week 8. Range: 0-35 mm Interpretation: Higher scores indicate greater tear production and a better outcome.
Acute Change in Unanesthetized Schirmer Test Score on Day 1
Mean change from the pre-dose measurement to the measurement taken 3 minutes after the first dose. Range: 0-35 mm Interpretation: Higher scores indicate greater tear production and a better outcome.
Change in Neuropathic Ocular Symptom Intensity
Change in pain, discomfort, or another identified neuropathic symptom measured using a 0-10 visual analog scale (VAS). Range: 0-10 Interpretation: Higher scores indicate greater pain or symptom severity and a worse outcome.
Change in Ocular Pain-Related Quality of Life
Change in quality of life measured using the Ocular Pain Assessment Survey (OPAS). Range: 0-10 Interpretation: Higher scores indicate greater ocular pain and symptom severity and a worse outcome.
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University of South Florida
Lead sponsor
Alcon Research
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
