Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency

NCT07502378 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: Study009655RTI #25-RX23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.

Conditions

Ocular Surface Disease; Neurotrophic Keratopathy Stage 1

Keywords

Ocular Surface Disease

Outcome Measures

Primary Outcomes (1)

• Unanesthetized Schirmer Test

  Mean change in unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1)

  8 weeks

Secondary Outcomes (1)

• Unanesthetized Schirmer test

  1 Day

Other Outcomes (2)

• Corneal Staining

  8 weeks

• Best Corrected Distance Visual Acuity

  8 weeks

Study Arms (1)

Acoltremon 0.003% Ophthalmic Solution

OTHER

Open Label treatment of Acoltremon

Drug: Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.; Other: Alternative would be patient exiting the trial and starting on tears or other standard of care.

Interventions

Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. DRUG

This is an FDA approved drug. The participants will be educated on the potential instillation site sensation that may occur as reported from the Pivotal Trials and that the sensation may differ between eyes due to the Neurotrophic Keratopathy. Qualified eyes must meet the inclusion and exclusion criteria. If both eyes qualify, then the one with the worst vision will be the study eye. If both eyes have equal visual acuity then the right eye will be the study eye.

Acoltremon 0.003% Ophthalmic Solution

Alternative would be patient exiting the trial and starting on tears or other standard of care. OTHER

This is an open label trial. If the patient does not do well on Acoltremon Ophthalmic Solution, then the participant will be removed from trial and put on standard of care treatment, other than Acoltremon.

Acoltremon 0.003% Ophthalmic Solution

Eligibility Criteria

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

You may qualify if:

• Neurotrophic Keratopathy stage 1 diagnosis based on the following: Presence of 3+ fluorescein staining in central cornea and decreased corneal sensation (Cochet-Bonnet less than 4cm in the central cornea)
• Baseline unanesthetized Schirmer's test ≤ 10 mm
• Females of childbearing potential must have a negative pregnancy test.
• Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen \<20/200).

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 8 days prior to the starting date and artificial tears 2 hours prior to the first study visit and remain off for the duration of the study.
• 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.
• Participation in another clinical trial concurrently

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida/Ophthalmology

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (5)

• Khalid M, Zahid E, Shaheer M. "Acoltremon: a novel advancement in dry eye disease management". Ann Med Surg (Lond). 2025 Oct 17;87(12):9121-9122. doi: 10.1097/MS9.0000000000004126. eCollection 2025 Dec. No abstract available.

  PMID: 41377326 BACKGROUND

• Pattar GR, Wirta D, Jerkins G, Paauw J, McLaurin EB, Liu A, Evans DG, Kenyon K, Cline N, Gupta PK, Meng I, Senchyna M; COMET-2 and COMET-3 Study Groups. Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies. Ophthalmology. 2025 Sep 30:S0161-6420(25)00605-0. doi: 10.1016/j.ophtha.2025.09.018. Online ahead of print.

  PMID: 41038456 BACKGROUND

• Lee A. Acoltremon: First Approval. Drugs. 2025 Oct;85(10):1307-1310. doi: 10.1007/s40265-025-02218-5. Epub 2025 Jul 30.

  PMID: 40736647 BACKGROUND

• Zhou Y, Zhang W, Sun F. Acoltremon: The first TRPM8 agonist approved for the treatment of dry eye disease. Drug Discov Ther. 2025 Jul 4;19(3):210-211. doi: 10.5582/ddt.2025.01048. Epub 2025 Jun 27.

  PMID: 40571589 BACKGROUND

• Methods of Reducing Corneal Endothelial Cell Loss U.S. Patent Application, PCT/US2014/066551, filed November 20, 2014 Developed novel methodology to assess decreased nerve density in patients at risk for endothelial cell loss and preventing endothelial cell loss through neuropeptide based therapies.

  BACKGROUND

Study Officials

• Pedram Hamrah, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedram Hamrah, MD

CONTACT

813-974-0948; phamrah@usf.edu

Susan Sherouse

CONTACT

813-974-0948; ssherous@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

Model Details: This is a single arm trial where all patients receive the same medication in one eye. This study drug is already FDA approved and this is to get further detail of performance of the medication.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)