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

Overview

About this study

The purpose of this study is to evaluate 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Joanne Shen, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20455987

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