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

Dry Eye Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02975557
• Other study ID #: 2015-0278
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 2016
• Est. completion date: April 13, 2017

Study information

• Verified date: November 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 13, 2017
• Est. primary completion date: April 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Graft vs Host Disease
• Meibomian Gland Dysfunction
• Ocular Graft vs Host Disease

Intervention

Drug:
• Brimonidine 0.15%
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.
• Placebo
Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.

Locations

Country	Name	City	State
United States	Illinois Eye and Ear Infirmary, University of Illinois	Chicago	Illinois
United States	Translational Clinic of Corneal Neurobiology Laboratory, Illinois Eye and Ear Infirmary, University of Illinois	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Sandeep Jain, MD	Ocugen

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Corneal Neurobiology Laboratory (National Eye Institute funded)
•   Dry Eye and ocular GVHD Clinic at University of Illinois at Chicago
•   Principal Investigator description