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

Sponsor
Dompé Farmaceutici S.p.A (Industry)
Overall Status
Completed
CT.gov ID
NCT04485546
Collaborator
Dompé US (Other)
37
5
1
18.6
7.4
0.4

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
37 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 :
Sep 9, 2020
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Mar 30, 2022

Arms and Interventions

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 Names:
  • OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution
  • Outcome Measures

    Primary Outcome Measures

    1. Corneal epithelial healing [Week 8]

      Percentage of patients who experience corneal epithelial healing assessed via fluorescein corneal staining

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    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

    Responsible Party:
    Dompé Farmaceutici S.p.A
    ClinicalTrials.gov Identifier:
    NCT04485546
    Other Study ID Numbers:
    • NGF0120
    First Posted:
    Jul 24, 2020
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2022