DOMPE -MT Neurotrophic Keratitis
Running, not enrolling · Phase 4
Conditions studied: Dry Eye, Neurotrophic Keratitis
In brief
TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis
Key facts
- Study ID
- NCT06947850
- Run by
- Toyos Clinic
- People needed
- 10
- Starts
- 2023-01-21
- Expected to finish
- 2025-09-25
- Last updated by the study team
- 2025-04-27
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Have a known hypersensitivity or contraindication to the investigational product or their components.
- Severe systemic allergy.
- Topical glaucoma medications or oral medications that are not being taken at a stable dose for the past 90 days.
- Topical dry eye medications within the last month except unpreserved artificial tears which will be allowed throughout the study as needed.
- Active viral, fungal or bacterial infection or active intraocular inflammation.
- Subjects must be unwilling to abstain from eyelash growth medications for the duration of the trial.
- Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1.
- Febrile illness within one week of screening visit.
- Treatment with another investigational drug or other investigational intervention withinone month of screening visit.
- Have serious or severe disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance.
- Subjects that are currently pregnant or intend to become pregnant during the course of the study, are breastfeeding, or who are unwilling to use highly effective birth control measures such as hormonal contraceptives, and/or mechanical barrier methods during the course of the trial.
- Use of contact lenses during trial.
- Amniotic membranes within two weeks prior to screening.
- Punctal plugs will be allowed as long as they have remained stable for at least 90 days.
- No neurostimulation including varencicline, acupuncture or TrueTear or like devices within one month of screening.
Where it is running
- Toyos Clinic — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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