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

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

Study Overview

• Status: Recruiting
• Conditions: Ocular Surface Disease; Neurotrophic Keratopathy Stage 1
• Intervention / Treatment: 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.

Detailed Description

This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production in subjects with stage I neurotrophic keratopathy (NK). The study drug, Acoltremon, is formulated to help increase tear production. Since the tissue breakdown of the cornea is causing NK, it is thought that this study treatment may help participants with this disease by enhancing wound healing, repair and regeneration through improving nerve function of the cornea.

Participants will be followed for 8 weeks, evaluating unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1), their mean change in Best Corrected distance visual acuity (ETDRS standards) from day 1 to week 8, and change in central corneal staining from baseline to week 8.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Susan Sherouse; Phone Number: 813-974-0948; Email: ssherous@usf.edu
• Study Contact Backup: Name: Pedram Hamrah, MD; Phone Number: 813-974-0948; Email: phamrah@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • University of South Florida/Ophthalmology
      • Contact: Susan Sherouse; Phone Number: 813-974-0948; Email: ssherous@usf.edu
      • Principal Investigator: Pedram Hamrah, MD
      • Contact: Angie Windham; Phone Number: 813-974-1423; Email: angiewindham@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Acoltremon 0.003% Ophthalmic Solution; Open Label treatment of Acoltremon

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unanesthetized Schirmer test	Mean change in unanesthetized Schirmer test score between 3 mins post-drop day 1 compared to pre-drop at day 1.	1 Day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Staining	Change from baseline central corneal staining (NEI) at week 8.	8 weeks
Best Corrected Distance Visual Acuity	Change from baseline mean BCDVA (ETDRS) at week 8	8 weeks

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Pedram Hamrah, MD, University of South Florida

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 27, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Ocular Surface Disease
• Other Study ID Numbers: Study009655; RTI #25-RX23 (Other Identifier: University of South Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are 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