Ocugen Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

Active Clinical Trials // Jan 28 2019
  • Sponsor: Ocugen, Inc
  • Principal Investigator:  Evan Warner
  • Study coordinator: Angie Adler or Kris Dietzman

Study Objective:

To evaluate the safety, tolerability, and efficacy of Brimonidine Nanoemulsion eye drops in patients with ocular Graft vs Host Disease (oGVHD)

Study Design:

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of ocular Graft Verses Host Disease (oGVHD). Two thirds of participants will receive Brimonidine and one third will receive ophthalmic buffered saline (placebo).

Criteria:

Inclusion Criteria:

  • Men or women ≥ 18 years of age
  • Diagnosis of “definite oGVHD using the International Chronic Ocular GVHD Consensus Group Revised Diagnostic criteria.
  • Ocular Discomfort score ≥ 3
  • Validated Bulbar Redness score ≥ 40
  • Subjects who are capable and willing to provide informed consent and follow study instructions
  • Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
  • Women who are not pregnant or lactating or post-menopausal or have undergone a sterilization procedure

Exclusion Criteria:

  • Allergic to brimonidine or any similar products, or excipients of brimonidine
  • Currently receiving any brimonidine preparation as a part of glaucoma management
  • Receiving or have received within 30 days any experimental systemic medication
  • Current use of contact lenses
  • Active ocular infection or ocular allergies
  • Any history of eyelid surgery or ocular surgery within the past 3 months
  • Corneal epithelial defect larger than 1 mm in either eye
  • Any anticipated or actual change in corticosteroid-containing eye drops, systemic corticosteroids/immunosuppressives, topical ocular antibiotics, cyclosporine ophthalmic emulsion 0.05% (Restasis®), or lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior

For more information or questions please call Angie Adler: 608-265-7557 or Kris Dietzman 608-263-9035