DEFENDO: Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis
Study Details
Study Description
Brief Summary
This study is to evaluate the safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj
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Drug: cenegermin-bkbj
Cenegermin-bkbj ophthalmic solution administered as one drop in affected eye(s) every 2 hours 6 times daily for 8 weeks
Other Names:
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Outcome Measures
Primary Outcome Measures
- Corneal epithelial healing [Week 8]
Percentage of patients who experience corneal epithelial healing assessed via fluorescein corneal staining
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female aged ≥ 18 years.
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Patients with Stage 1 NK defined by the Mackie criteria
Exclusion Criteria:
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Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
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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.
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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.
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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.
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Ocular surgery or elective ocular surgery expected during participation in the trial.
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Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | San Diego | San Diego | California | United States | 92122 |
2 | Edgewood | Edgewood | Kentucky | United States | 41017 |
3 | Boston | Boston | Massachusetts | United States | 02111 |
4 | Saint Louis | Saint Louis | Missouri | United States | 63131 |
5 | Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Dompé Farmaceutici S.p.A
- Dompé US
Investigators
- Study Chair: Flavio Mantelli, MD, PhD, Domp Farmaceutici SpA
Study Documents (Full-Text)
None provided.More Information
Publications
- NGF0120