Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study.
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OCU-300
Brimonidine Tartrate Nanoemulsion Eye Drops 0.18% given 2 times a day for 12 weeks.
  • Drug: Brimonidine Tartrate
    Brimonidine Tartrate Nanoemulsion Eye Drops given 2 times a day for 12 weeks.
    Other names:
    • OCU-300
Placebo Comparator
Placebos
Placebo - Ophthalmic buffered saline Eye Drops given 2 times a day for 12 weeks.
  • Drug: Placebos
    Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.
    Other names:
    • Placebo (For Brimonidine Tartrate)

More Details

Status
Terminated
Sponsor
Ocugen

Study Contact

Detailed Description

Ocular GVHD (oGVHD) is a common complication that occurs in 40-60% of patients who have undergone allogeneic bone marrow transplants. Driven by inflammation, oGVHD can result in damage to the ocular surface and tear-producing glands, which over time significantly diminishes quality of life and restricts daily activities due to visual impairment. Early studies in animals and humans indicate that Brimonidine nano-emulsion, also known as OCU300, may relieve the signs and symptoms of oGVHD. These symptoms include blurry vision, foreign body sensation, burning sensation, severe light sensitivity, chronic conjunctivitis (pink or red eye), dry eyes and eye pain. This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study in the United States conducted at approximately 15 centers. Upon meeting the eligibility criteria, enrolled subjects with a diagnosis of definite oGVHD will be randomly assigned in a 2:1 (test: control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.18% investigational product (test) or ophthalmic buffered saline (placebo).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.