Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
Condition: Graft Versus Host Disease; Ocular Surface Disease; oGVHD; Ocular Graft vs Host Disease; Brimonidine Tartrate; Lubricant Eye Drops; Ophthalmic Solutions; Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Brimonidine Tartrate; Placebos
Intervention description: Brimonidine Tartrate Nanoemulsion Eye Drops given 2 times a day for 12 weeks.; Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All subjects, investigators, and study personnel involved in the conduct of the study, including data management and statistics, will be masked to treatment assignment except for a specified staff member from the designated packaging vendor who will do the package labeling.
Unmasking will be permitted in a medical emergency that requires immediate knowledge of the subject's treatment assignment.
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ogvhd; ocular graft vs host; Ocular Surface Disease; Ocular Graft vs Host Disease; Brimonidine Tartrate; Lubricant Eye Drops; Ophthalmic Solutions; Graft vs Host Disease

Summary:

      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).
    

Eligibility 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 in at least one eye.

          -  Ocular Discomfort score ≥ 3

          -  Validated Bulbar Redness score ≥ 40 in both eyes

          -  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 or other treatment for glaucoma

          -  Receiving or have received any investigational drug or device within 30 days of
             screening

          -  Current use of contact lenses 14 days prior to screening

          -  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 (squared) in either eye

          -  Received corticosteroid-containing eye drops within 14 days prior to screening or
             planned use during the study

          -  Any change in corticosteroid-containing eye drops, systemic
             corticosteroids/immunosuppressives, topical ocular antibiotics, cyclosporine
             ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa®)
             or lifitegrast ophthalmic solution 5% (Xiidra®), or autologous serum tears within 30
             days prior to screening or planned change during the study