Clinical trial NCT02975557: Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD)
Official title: A Phase I/II Randomized, Placebo-Controlled, Double-Blind, Single-Center, Tolerability And Preliminary Efficacy Study Of Use of Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Dry Eye
Ocular Graft vs Host Disease
Meibomian Gland Dysfunction
Keywords: Brimonidine
Dry Eye
oGVHD
MGD
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Ocugen
First posted: 2016-11-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to establish whether patients with dry eye disease (DED) are able to tolerate receiving Brimonidine: 0.15% eye drops two times a day for twelve weeks (primary tolerability objective) and to investigate the preliminary efficacy of Brimonidine 0.15% topical eye drop solution in treating Meibomian Gland Dysfunction (MGD) (primary efficacy objective).

Meibomian Gland dysfunction can happen with numerous conditions such as Rosacea, Sjögren's syndrome, and oGVHD. In order to limit the influence of differing etiologies on the outcome of this trial, the investigator has limited the screening to MGD that accompanies oGVHD.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older.
2. Capable of giving informed consent and does provide informed consent.
3. Diagnosis of Meibomian Gland Disease
4. Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 7 days of the participant receiving first dose of study drug along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the participant and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a participant suspects pregnancy after being enrolled, another pregnancy test will be administered. If the test is positive, the participant will be discontinued from the study immediately.

Exclusion Criteria:

1. Allergic to Brimonidine or any similar products, or excipients of Brimonidine
2. Currently receiving any Brimonidine preparation as a part of glaucoma management
3. Receiving or have received within 30 days any experimental systemic medication.
4. Active ocular infection or ocular allergies.
5. Any history of eyelid surgery or ocular surgery within the past 3 months.
6. Corneal epithelial defect larger than 1 mm2 in either eye.
7. Have active drug/alcohol dependence or abuse history.
8. Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

Primary outcomes:
measure: Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois Eye and Ear Infirmary, University of Illinois
state: Illinois
city: Chicago
country: United States
facility: Translational Clinic of Corneal Neurobiology Laboratory, Illinois Eye and Ear Infirmary, University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sandeep Jain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tibrewal S, Sarkar J, Jassim SH, Gandhi S, Sonawane S, Chaudhary S, Byun YS, Ivanir Y, Hallak J, Horner JH, Newcomb M, Jain S. Tear fluid extracellular DNA: diagnostic and therapeutic implications in dry eye disease. Invest Ophthalmol Vis Sci. 2013 Dec 11;54(13):8051-61. doi: 10.1167/iovs.13-12844.
citation: Sonawane S, Khanolkar V, Namavari A, Chaudhary S, Gandhi S, Tibrewal S, Jassim SH, Shaheen B, Hallak J, Horner JH, Newcomb M, Sarkar J, Jain S. Ocular surface extracellular DNA and nuclease activity imbalance: a new paradigm for inflammation in dry eye disease. Invest Ophthalmol Vis Sci. 2012 Dec 17;53(13):8253-63. doi: 10.1167/iovs.12-10430.