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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-04-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Ocular Graft vs Host Disease Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Brimonidine 0.15%

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

Group Type ACTIVE_COMPARATOR

Brimonidine 0.15%

Intervention Type DRUG

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

Brimonidine 0.075%

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.

Group Type ACTIVE_COMPARATOR

Brimonidine 0.075%

Intervention Type DRUG

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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Brimonidine 0.15%

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

Intervention Type DRUG

Brimonidine 0.075%

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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Alphagan P Alphagan P Refresh plus Artificial Tear

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No