"Acoltremon: a novel advancement in dry eye disease management".
Muddassir Khalid, Esha Zahid, Muhammad Shaheer
https://pubmed.ncbi.nlm.nih.gov/41377326Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID07502378
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
Led by University of South Florida · Updated on 2026-03-31
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Acoltremon ophthalmic solution 0.003% on tear production in patients with Stage 1 Neurotrophic Keratopathy, a condition where corneal tissue breakdown reduces tear production and nerve function. This Phase 4 study aims to gather clinical data on how this treatment may improve wound healing and nerve regeneration in the cornea. Participants will receive Acoltremon eye drops twice daily in both eyes for 8 weeks. If both eyes qualify, the eye with worse vision will be studied. This open-label trial monitors changes in tear production and visual acuity over the treatment period. Participants who do not respond well may be switched to standard care treatments. During the study, participants will be assessed for tear production using the unanesthetized Schirmer test at baseline and after 8 weeks. Visual acuity and corneal staining will also be evaluated. Safety is monitored throughout. The total participation lasts 8 weeks, with careful follow-up to measure changes in ocular surface disease signs and symptoms.
CONDITIONS
Brief Title
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of Stage 1 Neurotrophic Keratopathy based on specific corneal staining and decreased corneal sensation
- Baseline unanesthetized Schirmer's test score of 10 mm or less
- Females of childbearing potential must have a negative pregnancy test
- Best corrected distance visual acuity in the study eye of at least +1.0 Log MAR (better than 20/200)
You will not qualify if you...
- Active ocular infection or intraocular inflammation
- Persistent epithelial defect, corneal ulcer, corneal scar, or corneal edema
- Other ocular conditions requiring topical medications during treatment
- History of severe systemic or ocular allergies
- Inability to stop topical medications 8 days before and artificial tears 2 hours before study start
- Ocular surgery within 3 months before study visit or expected during the study
- Use of refractive or therapeutic contact lenses during the study
- Pregnancy, breastfeeding, or intent to become pregnant during treatment
- Drug addiction or alcohol abuse
- Participation in another clinical trial at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 8 weeks
Participants receive topical Acoltremon 0.003% ophthalmic solution twice daily in both eyes for 8 weeks to help increase tear production and improve corneal nerve function.
Baseline visit and follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
University of South Florida/Ophthalmology
Tampa, Florida, United States, 33612
Actively Recruiting
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Research Team
P
Pedram Hamrah, MD
S
Susan Sherouse
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies.
Guruprasad R Pattar, David Wirta, Gary Jerkins...
https://pubmed.ncbi.nlm.nih.gov/41038456Acoltremon: First Approval.
Arnold Lee
https://pubmed.ncbi.nlm.nih.gov/40736647Acoltremon: The first TRPM8 agonist approved for the treatment of dry eye disease.
Yang Zhou, Wenzhu Zhang, Fusheng Sun
https://pubmed.ncbi.nlm.nih.gov/40571589