Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- University of South Florida
- Study ID
- NCT07502378
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Neurotrophic Keratopathy Stage 1
- Ocular Surface Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. — DRUGThis 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.
- Alternative would be patient exiting the trial and starting on tears or other standard of care. — OTHERThis 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.
Study Details
STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
Key Dates
- Start date
- Mar 27, 2026
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Acoltremon 0.003% Ophthalmic SolutionOpen Label treatment of Acoltremon
Primary Outcome Measure
Unanesthetized Schirmer Test [ Time Frame: 8 weeks ]
Central Contacts
- Pedram Hamrah, MD813-974-0948
- Susan Sherouse813-974-0948
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of South Florida/Ophthalmology | Tampa | Florida | 33612 | Pedram Hamrah, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Tampa, FL
By research site
Related Studies
- Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical MedicationsRecruiting · University of California, Los Angeles · Fountain Valley, California
- This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry EyePHASE4 · Not Yet Recruiting · Pittsburgh Research Institute · Sewickley, Pennsylvania
- The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye DiseaseRecruiting · Rinsada · Pittsburgh, Pennsylvania