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

NCT07849803 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: RTI #26-RCD0.16
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Pain; Dry Eye

Keywords

Dry Eye; Eye pain; tear deficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  Time frame: Baseline to Week 8

Secondary Outcomes (3)

• Acute Change in Unanesthetized Schirmer Test Score on Day 1

  Pre-dose to 3 minutes post-dose on Day 1

• Change in Neuropathic Ocular Symptom Intensity

  Baseline to Week 8

• Change in Ocular Pain-Related Quality of Life

  Baseline to Week 8

Study Arms (1)

Acoltremon Group

EXPERIMENTAL

Patients will administer one drop of Acoltremon Ophthalmic Solution 0.003% twice a day for 8 weeks.

Drug: acoltremon ophthalmic solution 0.003%

Interventions

acoltremon ophthalmic solution 0.003% DRUG

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

Acoltremon Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Females of childbearing potential must have a negative pregnancy test.
• Change of 50% or more improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX).

You may not qualify if:

• 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.
• 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.
• History of any ocular surgery within three months before study Visit 1.
• Ocular surgery expected during the duration of the study.
• Use of refractive/therapeutic contact lenses during the study period.
• Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.
• Drug addiction/alcohol abuse within the last year.
• Participation in another clinical trial concurrently.

Sponsors & Collaborators

• University of South Florida: lead
• Alcon Research: collaborator

Study Sites (1)

The University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (9)

• Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.

  PMID: 16697110 BACKGROUND

• Villani E, Baudouin C, Efron N, Hamrah P, Kojima T, Patel SV, Pflugfelder SC, Zhivov A, Dogru M. In vivo confocal microscopy of the ocular surface: from bench to bedside. Curr Eye Res. 2014 Mar;39(3):213-31. doi: 10.3109/02713683.2013.842592. Epub 2013 Nov 11.

  PMID: 24215436 BACKGROUND

• Qazi Y, Hurwitz S, Khan S, Jurkunas UV, Dana R, Hamrah P. Validity and Reliability of a Novel Ocular Pain Assessment Survey (OPAS) in Quantifying and Monitoring Corneal and Ocular Surface Pain. Ophthalmology. 2016 Jul;123(7):1458-68. doi: 10.1016/j.ophtha.2016.03.006. Epub 2016 Apr 16.

  PMID: 27089999 BACKGROUND

• Dieckmann G, Goyal S, Hamrah P. Neuropathic Corneal Pain: Approaches for Management. Ophthalmology. 2017 Nov;124(11S):S34-S47. doi: 10.1016/j.ophtha.2017.08.004.

  PMID: 29055360 BACKGROUND

• Galor A, Levitt RC, Felix ER, Martin ER, Sarantopoulos CD. Neuropathic ocular pain: an important yet underevaluated feature of dry eye. Eye (Lond). 2015 Mar;29(3):301-12. doi: 10.1038/eye.2014.263. Epub 2014 Nov 7.

  PMID: 25376119 BACKGROUND

• Belmonte C, Nichols JJ, Cox SM, Brock JA, Begley CG, Bereiter DA, Dartt DA, Galor A, Hamrah P, Ivanusic JJ, Jacobs DS, McNamara NA, Rosenblatt MI, Stapleton F, Wolffsohn JS. TFOS DEWS II pain and sensation report. Ocul Surf. 2017 Jul;15(3):404-437. doi: 10.1016/j.jtos.2017.05.002. Epub 2017 Jul 20.

  PMID: 28736339 BACKGROUND

• Marfurt C, Anokwute MC, Fetcko K, Mahony-Perez E, Farooq H, Ross E, Baumanis MM, Weinberg RL, McCarron ME, Mankowski JL. Comparative Anatomy of the Mammalian Corneal Subbasal Nerve Plexus. Invest Ophthalmol Vis Sci. 2019 Dec 2;60(15):4972-4984. doi: 10.1167/iovs.19-28519.

  PMID: 31790560 BACKGROUND

• Cruzat A, Qazi Y, Hamrah P. In Vivo Confocal Microscopy of Corneal Nerves in Health and Disease. Ocul Surf. 2017 Jan;15(1):15-47. doi: 10.1016/j.jtos.2016.09.004. Epub 2016 Oct 19.

  PMID: 27771327 BACKGROUND

• Marfurt CF, Cox J, Deek S, Dvorscak L. Anatomy of the human corneal innervation. Exp Eye Res. 2010 Apr;90(4):478-92. doi: 10.1016/j.exer.2009.12.010. Epub 2009 Dec 29.

  PMID: 20036654 BACKGROUND

MeSH Terms

Conditions

Eye Pain; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Lacrimal Apparatus Diseases

Study Officials

• Pedram Hamrah, MD

  University of South Florida/Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mya L. Reese

CONTACT

18139742020; MCOM-Eyeresearch@usf.edu

Susan Sherouse

CONTACT

8139742020; MCOM-Eyeresearch@usf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)