Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD)

Sandeep Jain, MD

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Dry Eye; Meibomian Gland Dysfunction; Ocular Graft vs Host Disease

Treatments: Drug: Brimonidine 0.15%; Drug: Brimonidine 0.075%; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02975557

2015-0278

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 3 patient groups, including a placebo group

Brimonidine 0.15%

Active Comparator group

Description:

Brimonidine 0.15% eye drops 2 times a day for 12 weeks

Treatment:

Drug: Brimonidine 0.15%

Brimonidine 0.075%

Active Comparator group

Description:

Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks.

Treatment:

Drug: Brimonidine 0.075%

Placebo

Placebo Comparator group

Description:

Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.

Treatment:

Drug: Placebo