Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD)
Status: | Terminated |
---|---|
Conditions: | Ocular, Hematology |
Therapuetic Areas: | Hematology, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/1/2017 |
Start Date: | May 2016 |
End Date: | March 28, 2017 |
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)
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 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.
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 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.
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.
We found this trial at
2
sites
1855 West Taylor Street
Chicago, Illinois 60612
Chicago, Illinois 60612
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1200 West Harrison Street
Chicago, Illinois 60612
Chicago, Illinois 60612
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