Clinical trial NCT03591874: Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
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
Keywords: ogvhd
ocular graft vs host
Ocular Surface Disease
Ocular Graft vs Host Disease
Brimonidine Tartrate
Lubricant Eye Drops
Ophthalmic Solutions
Graft vs Host Disease
Lead sponsor: Ocugen
Sponsor class: INDUSTRY
First posted: 2018-07-19
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score
timeFrame: Baseline, Day 84
measure: Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score
timeFrame: Baseline, Day 84
Secondary outcomes:
measure: Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores
timeFrame: Baseline, Day 84
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Prairie Village
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan, Kellogg Eye Center
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: OHSU Casey Eye Institute | Cornea Division
state: Oregon
city: Philadelphia
country: United States
facility: University of Penn Scheie Eye Institute,
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univeristy of Pittsburgh Medical Center Eye Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin Dept. of Ophthalmology and Visual Sciences
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: