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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04485546
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : January 6, 2021
Dompé US
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

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
Neurotrophic Keratitis Drug: cenegermin-bkbj Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj 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

Primary Outcome Measures :
  1. Corneal epithelial healing [ Time Frame: Week 8 ]
    Percentage of patients who experience corneal epithelial healing assessed via fluorescein corneal staining

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04485546

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Contact: Georgea Pasedis, PharmD Vice President, Global Medical Affairs, Dompé US 1-833-366-7387
Contact: Bianca Baker, PhD Director, US Ophthalmics, Medical and Clinical Affairs, Dompé US 1-833-366-7387

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United States, California
San Diego Recruiting
San Diego, California, United States, 92122
United States, Kentucky
Edgewood Recruiting
Edgewood, Kentucky, United States, 41017
United States, Massachusetts
Boston Recruiting
Boston, Massachusetts, United States, 02111
United States, Missouri
Saint Louis Recruiting
Saint Louis, Missouri, United States, 63131
United States, Pennsylvania
Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Dompé Farmaceutici S.p.A
Dompé US
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Study Chair: Flavio Mantelli, MD, PhD Domp Farmaceutici SpA
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Responsible Party: Dompé Farmaceutici S.p.A Identifier: NCT04485546    
Other Study ID Numbers: NGF0120
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dompé Farmaceutici S.p.A:
Stage 1 Neurotrophic Keratitis
Corneal Disease
Ocular Disease
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions