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

Study Overview
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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.

Official Title
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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)

Conditions
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Dry Eye, Ocular Graft vs Host Disease, Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: Brimonidine 0.15%
* Drug: Brimonidine 0.075%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older. Capable of giving informed consent and does provide informed consent. Diagnosis of Meibomian Gland Disease 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: Allergic to Brimonidine or any similar products, or excipients of Brimonidine Currently receiving any Brimonidine preparation as a part of glaucoma management Receiving or have received within 30 days any experimental systemic medication. 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 mm2 in either eye. Have active drug/alcohol dependence or abuse history. Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brimonidine 0.15%<br>Brimonidine 0.15% eye drops 2 times a day for 12 weeks | Drug: Brimonidine 0.15%<br>* Brimonidine 0.15% eye drops 2 times a day for 12 weeks<br>* Other names: Alphagan P;|
| Active Comparator: Brimonidine 0.075%<br>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. | Drug: Brimonidine 0.075%<br>* 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.<br>* Other names: Alphagan P;|
| Placebo Comparator: Placebo<br>Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks. | Drug: Placebo<br>* Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.<br>* Other names: Refresh plus Artificial Tear;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks. | Subjects assessed their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100 mm horizontal line with verbal descriptors at either end and marks at an equal distance starting from 0 mm and leading up to 100 mm (0 10 20 30 40 50 60 70 80 90 100). The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), week 3, week 6, week 9 and week 12. Subjects will place a single slash mark across the horizontal line between the end labeled completely intolerable (0 mm) and easily tolerable (100mm). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brimonidine, Dry Eye, oGVHD, MGD