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DEFENDO


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)
Therapeutic Area Neurotrophic Keratitis
Principal Investigator Pedram Hamrah, MD
Min Age 18 Years
Gender All
Contact Nancy Gee
617- 636-5489
ngee@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04485546

Overview

This clinical study will be a multi-center, open label, prospective study of 8 weeks of treatment with 24 weeks of follow-up to evaluate the safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered as one drop in the affected eye(s), 6 times per day at 2-hour intervals, for eight weeks in patients with Stage 1 Neurotrophic Keratitis (NK).

Study Details

Inclusion Criteria

  • Patients with Stage 1 NK
  • Snellen ≥20/200
  • Decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer)

Exclusion Criteria

  • active ocular infection
  • severe systemic allergy or severe ocular allergy
  • active severe blepharitis and/or severe meibomian gland disease

Study Requirements

Your participation in this study will last approximately thirty-four (34) weeks. The study will involve four phases:

  • A SCREENING period where procedures to determine study eligibility will be performed
  • A WASHOUT period of 14 days with no additional treatment for NK except commercially available artificial tears that will be provided to you, which you will be allowed to use up to four times per day
  • A TREATMENT period of 8 weeks where eligible participants will receive OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered six times daily at 2-hour intervals.
  • A FOLLOW-UP period of 24 weeks if you are completely healed, during which time no treatment will be allowed except for commercially available artificial tears that will be provided to you, or if you are not completely healed and do not meet criteria of discontinuation of the study. If you have not completely healed at week 8, you may receive other treatment at the physician’s discretion.
    • If you experience worsening, deterioration, or no change in NK from Baseline (Day 0), you will not enter the FOLLOW-UP period and will exit the study. Additional details about study discontinuation are included later in this document.