| Registry | NCT07849803, acronym AURORA |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 28 (Estimated) |
| Sponsor | University of South Florida (Other); collaborators: Alcon Research |
| Conditions | Ocular Pain, Dry Eye |
| Interventions | acoltremon ophthalmic solution 0.003% (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-09-30, last updated 2026-10-06 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Ocular Pain All trials for Dry Eye All trials of acoltremon ophthalmic solution 0.003%
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.
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 (Visual Analog Scale), reduced corneal nerve density and microneuromas on IVCM (In Vivo Confocal Microscopy), 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 0.003% in both eyes twice daily for 8 weeks. One qualifying eye per participant will be designated as the study eye for analysis. There is no placebo or comparator group.
The primary endpoint is the mean change in unanesthetized Schirmer score from pre-drop baseline to 3 minutes post-drop at Week 8. Secondary endpoints include acute change in Schirmer score on Day 1, change in neuropathic ocular symptom intensity on the VAS (Visual Analog Scale), and change in quality of life measured by OPAS (Ocular Pain Assessment Survey). Exploratory outcomes include changes in corneal nerve structure and function, corneal sensitivity, OSDI (Ocular Surface Disease Index) scores, drop comfort, and treatment satisfaction.
Safety monitoring will focus on corneal staining, visual acuity, discomfort following drop administration, and adverse events, with a safety assessment conducted after the first five participants.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Acoltremon Group | Experimental | Drug: acoltremon ophthalmic solution 0.003% | Patients will administer one drop of Acoltremon Ophthalmic Solution 0.003% twice a day for 8 weeks. |
Sex: All, ages: 18 Years to any
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% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX). Exclusion Criteria: 1. Evidence of any active ocular infection or any intraocular inflammation. 2. Evidence of any persistent epithelial defect/ulcer or any corneal scar/corneal edema. 3. Presence of any other ocular conditions that require topical medications during the treatment phase. 4. History of severe systemic allergies or severe ocular allergies. 5. Inability to suspend topical medications and varenicline 8 days prior to the starting date, except for artificial and serum tears for which subjects must be stable on current regimen for ≥3 months with no changes during the trial. 6. History of any ocular surgery within three months before study Visit 1. 7. Ocular surgery expected during the duration of the study. 8. Use of refractive/therapeutic contact lenses during the study period. 9. Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period. 10. Drug addiction/alcohol abuse within the last year. 11. Participation in another clinical trial concurrently.
| Facility | City | Country | Status |
|---|---|---|---|
| The University of South Florida | Tampa, Florida | United States |