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

NCT ID: NCT03591874

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-23
• Study Completion Date: 2020-04-30

Brief 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).

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).

Conditions

Graft Versus Host Disease; Ocular Surface Disease; oGVHD; Ocular Graft vs Host Disease; Brimonidine Tartrate; Lubricant Eye Drops; Ophthalmic Solutions; Graft vs Host Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OCU-300

Brimonidine Tartrate Nanoemulsion Eye Drops 0.18% given 2 times a day for 12 weeks.

Group Type: EXPERIMENTAL

Brimonidine Tartrate

Intervention Type: DRUG

Brimonidine Tartrate Nanoemulsion Eye Drops given 2 times a day for 12 weeks.

Placebos

Placebo - Ophthalmic buffered saline Eye Drops given 2 times a day for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.

Interventions

Brimonidine Tartrate

Brimonidine Tartrate Nanoemulsion Eye Drops given 2 times a day for 12 weeks.

Intervention Type: DRUG

Placebos

Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

OCU-300; Placebo (For Brimonidine Tartrate)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocugen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic

Phoenix, Arizona, United States

Byers Eye Institute at Stanford University

Palo Alto, California, United States

Emory Eye Center

Atlanta, Georgia, United States

University of Kansas Medical Center

Prairie Village, Kansas, United States

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

OHSU Casey Eye Institute | Cornea Division

Portland, Oregon, United States

University of Penn Scheie Eye Institute,

Philadelphia, Pennsylvania, United States

Univeristy of Pittsburgh Medical Center Eye Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Wisconsin Dept. of Ophthalmology and Visual Sciences

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OCU-300-301

Identifier Type: -

Identifier Source: org_study_id