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Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis (DEFENDO)

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ClinicalTrials.gov Identifier: NCT04485546
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : January 6, 2021
Sponsor:
Collaborator:
Dompé US
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Tracking Information
First Submitted Date  ICMJE July 21, 2020
First Posted Date  ICMJE July 24, 2020
Last Update Posted Date January 6, 2021
Actual Study Start Date  ICMJE September 9, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
Corneal epithelial healing [ Time Frame: Week 8 ]
Percentage of patients who experience corneal epithelial healing assessed via fluorescein corneal staining
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neurotrophic Keratitis
Intervention  ICMJE 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 Name: OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution
Study Arms  ICMJE Experimental: OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj
Intervention: Drug: cenegermin-bkbj
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2020)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female aged ≥ 18 years.
  2. Patients with Stage 1 NK defined by the Mackie criteria

Exclusion Criteria:

  1. Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Georgea Pasedis, PharmD Vice President, Global Medical Affairs, Dompé US 1-833-366-7387 georgea.pasedis@dompe.com
Contact: Bianca Baker, PhD Director, US Ophthalmics, Medical and Clinical Affairs, Dompé US 1-833-366-7387 bianca.baker@dompe.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04485546
Other Study ID Numbers  ICMJE NGF0120
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dompé Farmaceutici S.p.A
Study Sponsor  ICMJE Dompé Farmaceutici S.p.A
Collaborators  ICMJE Dompé US
Investigators  ICMJE
Study Chair: Flavio Mantelli, MD, PhD Domp Farmaceutici SpA
PRS Account Dompé Farmaceutici S.p.A
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP