NCT03591874

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

A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Ocugen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Brimonidine Tartrate	Brimonidine Tartrate Nanoemulsion 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.

Timeline

• Start date: 2018-12-23
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2018-07-19
• Last updated: 2022-07-06
• Results posted: 2022-07-06

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study