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

• Status: Completed
• Trial end date: 2020-06-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocugen
• Treatments: Brimonidine Tartrate; Ophthalmic Solutions

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