Effect of Acoltremon Ophthalmic Solution 0.003% on Tear Production and Symptoms in Patients With Tear Deficiency and Concurrent Neuropathic Corneal Pain (AURORA)

October 1, 2026 updated by: 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 (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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • The University of South Florida
        • Principal Investigator:
          • Pedram Hamrah, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acoltremon Group

Patients will administer one drop of Acoltremon Ophthalmic Solution 0.003% twice a day for 8 weeks.
Drug: acoltremon ophthalmic solution 0.003%

acoltremon ophthalmic solution 0.003%, one drop, twice a day, into the study eye, for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Unanesthetized Schirmer Test Score at Week 8
Time Frame: Time frame: Baseline to 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.
Time frame: Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Change in Unanesthetized Schirmer Test Score on Day 1
Time Frame: Pre-dose to 3 minutes post-dose 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.
Pre-dose to 3 minutes post-dose on Day 1
Change in Neuropathic Ocular Symptom Intensity
Time Frame: Baseline to Week 8

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.
Baseline to Week 8
Change in Ocular Pain-Related Quality of Life
Time Frame: Baseline to Week 8

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.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Pedram Hamrah, MD, University of South Florida/Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 24, 2026

First Submitted That Met QC Criteria

September 24, 2026

First Posted (Actual)

September 30, 2026

Study Record Updates

Last Update Posted (Actual)

October 6, 2026

Last Update Submitted That Met QC Criteria

October 1, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTI #26-RCD0.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The University of South Florida Eye Institute is not a pharmacy distribution company, the information being collected is for medical science to improve patient care options.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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