Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis
NCT ID: NCT04485546
Last Updated: 2025-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
37 participants
INTERVENTIONAL
2020-09-09
2022-03-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj
cenegermin-bkbj ophtalmic solution administered as one drop in affected eye(s) every 2 hours 6 times daily for 8 weeks
cenegermin-bkbj
OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered as one drop in the affected eye(s), 6 times a day at 2-hour intervals for 8 weeks, in patients with Stage 1 neurotrophic keratitis.
Interventions
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cenegermin-bkbj
OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered as one drop in the affected eye(s), 6 times a day at 2-hour intervals for 8 weeks, in patients with Stage 1 neurotrophic keratitis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with Stage 1 NK defined by the Mackie criteria
Exclusion Criteria
2. Have current or history of conditions that may confound the study data including but not limited to Ocular Cicatricial Pemphigoid (OCP), Graft Versus Host Disease (GVHD), neuromyelitis optica, uncontrolled dry eye, and Steven Johnson's syndrome.
3. History of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the subject's participation in the trial) or chronic conjunctivitis and/or keratitis other than dry eye disease.
4. Patients with severe vision loss with no potential for visual improvement in the study eye, in the opinion of the investigator, or if the subject is deemed legally blind.
5. Ocular surgery or elective ocular surgery expected during participation in the trial.
6. Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.
18 Years
ALL
No
Sponsors
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Dompé US
UNKNOWN
Dompé Farmaceutici S.p.A
INDUSTRY
Responsible Party
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Principal Investigators
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Flavio Mantelli, MD, PhD
Role: STUDY_CHAIR
Domp Farmaceutici SpA
Locations
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San Diego
San Diego, California, United States
Edgewood
Edgewood, Kentucky, United States
Boston
Boston, Massachusetts, United States
Saint Louis
St Louis, Missouri, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Mastropasqua L, Massaro-Giordano G, Nubile M, Sacchetti M. Understanding the Pathogenesis of Neurotrophic Keratitis: The Role of Corneal Nerves. J Cell Physiol. 2017 Apr;232(4):717-724. doi: 10.1002/jcp.25623. Epub 2016 Oct 17.
Hamrah P, Massaro-Giordano M, Schanzlin D, Holland E, Berdy G, Goisis G, Pasedis G, Mantelli F. Phase IV Multicenter, Prospective, Open-Label Clinical Trial of Cenegermin (rhNGF) for Stage 1 Neurotrophic Keratopathy (DEFENDO). Ophthalmol Ther. 2024 Feb;13(2):553-570. doi: 10.1007/s40123-023-00866-y. Epub 2024 Jan 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NGF0120
Identifier Type: -
Identifier Source: org_study_id