- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485546
Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis (DEFENDO)
June 23, 2023 updated by: Dompé Farmaceutici S.p.A
An 8-week, Multicenter, Open Label, Prospective Study With 24 Weeks of Follow-up to Evaluate Safety and Efficacy of OXERVATE™ 0.002% (20 mcg/mL) Cenegermin-bkbj Ophthalmic Solution in Patients With Stage 1 Neurotrophic Keratitis (NK)
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Diego, California, United States, 92122
- San Diego
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Kentucky
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Edgewood, Kentucky, United States, 41017
- Edgewood
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Boston
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Missouri
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Saint Louis, Missouri, United States, 63131
- Saint Louis
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Philadelphia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female aged ≥ 18 years.
- Patients with Stage 1 NK defined by the Mackie criteria
Exclusion Criteria:
- Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
- 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.
- 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.
- 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.
- Ocular surgery or elective ocular surgery expected during participation in the trial.
- Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OXERVATE™ 0.002% (20 mcg/mL) 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Corneal Epithelial Healing
Time Frame: Week 8
|
Percentage of patients who experience corneal epithelial healing.
Corneal epithelial healing was defined by the central reading center as the absence of persistent epithelial staining abnormalities related to disease.
|
Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Flavio Mantelli, MD, PhD, Domp Farmaceutici SpA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2020
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
March 30, 2022
Study Registration Dates
First Submitted
July 21, 2020
First Submitted That Met QC Criteria
July 23, 2020
First Posted (Actual)
July 24, 2020
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 23, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NGF0120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurotrophic Keratitis
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Dompé Farmaceutici S.p.ARecruitingNeurotrophic KeratitisUnited States
-
University of California, Los AngelesRecruiting
-
University of AlbertaWithdrawn
-
Sight Medical Doctors PLLCDompé, US, Inc.RecruitingNeurotrophic Keratitis | Neurotrophic Ulcer | Neurotrophic Corneal Ulcer | Neurotrophic KeratoconjunctivitisUnited States
-
Recordati Rare DiseasesSyneos HealthRecruitingNeurotrophic KeratitisUnited Kingdom, Spain, Italy, United States, Germany, France, Hungary
-
Dompé Farmaceutici S.p.ACompletedNeurotrophic KeratitisUnited States
-
Stanford UniversityCompleted
-
BRIM Biotechnology Inc.Not yet recruiting
-
Claris Biotherapeutics, Inc.RecruitingNeurotrophic KeratitisUnited States, Canada
-
University Hospital, Strasbourg, FranceTerminated
Clinical Trials on cenegermin-bkbj
-
Tufts Medical CenterDompé Farmaceutici S.p.AWithdrawn
-
Stanford UniversityCompleted
-
Sight Medical Doctors PLLCDompé, US, Inc.RecruitingNeurotrophic Keratitis | Neurotrophic Ulcer | Neurotrophic Corneal Ulcer | Neurotrophic KeratoconjunctivitisUnited States
-
Dompé Farmaceutici S.p.ACromsourceCompleted
-
Dompé Farmaceutici S.p.ACompletedDry Eye SyndromeUnited States
-
Dompé Farmaceutici S.p.ACompleted
-
University of California, Los AngelesRecruiting
-
Dompé Farmaceutici S.p.AActive, not recruiting
-
Dompé Farmaceutici S.p.ACromsourceCompletedHealthy VolunteersUnited States
-
Dompé Farmaceutici S.p.ACompletedNeurotrophic KeratitisUnited States