NCT02975557

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

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sandeep Jain, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Brimonidine 0.15%	Brimonidine 0.15% eye drops 2 times a day for 12 weeks
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.
DRUG	Placebo	Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-04-13
• Completion: 2017-04-13
• First posted: 2016-11-29
• Last updated: 2019-11-08
• Results posted: 2019-11-08

Locations

2 sites across 1 country: United States