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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

Study acronym: AURORA
StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Secondary endpoints: details revised at 3 of 3 entries
    • Study description expanded, about 18 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07849803
Lead Sponsor University of South Florida
Collaborators: Alcon Research
Conditions
(from sponsor)		 Ocular Pain, Dry Eye
Related terms Dry Eye Syndromes, Eye Pain
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov