Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects
Condition: Persistent Corneal Epithelial Defects
Intervention: Nexagon; Vehicle only
Intervention description: There will be 3 groups of patients with persistent epithelial defects, treated in a dose-escalation fashion from 1µg to 3µg to 10 µg. Each group will consist of 18 patients randomized to Nexagon and 6 patients randomized to placebo only.; There will be 3 groups of patients with persistent epithelial defects, treated in a dose-escalation fashion from 1µg to 3µg to 10 µg. Each group will consist of 18 patients randomized to Nexagon and 6 patients randomized to placebo only.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: persistent epithelial defect; cornea

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with
      persistent corneal epithelial defects (PED) resulting from corneal epithelial debridement
      during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns, post-PRK, or
      post-corneal transplant surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 18 years and over.

          -  Female subjects must be a) postmenopausal, b) surgically sterilized, c) practicing
             abstinence, or d) using a hormonal contraceptive, intrauterine device, diaphragm with
             spermicide, or condom with spermicide for the duration of the study.

          -  Subjects who are able to attend all follow-up visits and who are able to comply with
             all study procedures.

          -  Subjects who are willing and able to give written informed consent to take part in the
             study.

          -  Subjects with a PED, defined as follows: "a corneal epithelial defect persisting for
             at least 14 days and not longer than 28 days."

          -  In the Investigator's opinion, the defect is persistent i.e., the defect has not shown
             improvement despite conventional treatment such as tear supplements and bandage
             contact lenses.

          -  The original defect to the cornea must have resulted from corneal epithelial
             debridement during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal
             burns, post-PRK, or post-corneal transplant surgery.

        Exclusion Criteria:

          -  Use of concomitant ocular medications in the screening period that are not specified
             in standardized PED treatment regimen

          -  Likely to require the use of concomitant ocular medications that are not specified in
             the standardized PED treatment regime during the study follow-up period

          -  Decrease or increase in the PED by more than 50% during the screening period.

          -  Have an active eyelid or ocular infectious process of any sort, in the opinion of the
             Investigator.

          -  Subjects with corneal perforation or impending corneal perforation.

          -  Subjects with severe eyelid abnormalities contributory to the persistence of the PED.

          -  Subjects with bilateral PED, if the smaller PED has a longest diameter of > 2 mm.
             (Note: if bilateral PED is present and the smaller PED is < 2 mm, the subject is
             eligible. In this situation only the eye with the larger PED should be entered into
             the study).

          -  Female subjects who are pregnant or breastfeeding. Female subjects who are neither
             postmenopausal nor surgically sterile require a negative urine pregnancy test on Day 0
             (plus or minus 1 day) visit.

          -  Subjects who have a history of AIDS or HIV.

          -  Subjects with any other condition which, in the Investigator's opinion, would exclude
             the subject from participating.

          -  Treatment with systemic corticosteroids (equivalent to > 10 mg/day of prednisone) or
             immunosuppressive or chemotherapeutic agents within 7 days prior to Day 0 (plus or
             minus 1 day) visit, or likely to receive one of these therapies during study
             participation

          -  Subjects who have participated in a clinical trial within 30 days prior to Day 0 (plus
             or minus 1 day) visit.