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Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

NCT03591874 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2022-07-06

Study results available
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Summary

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of ocular Graft Verses Host Disease (oGVHD). Two thirds of participants will receive Brimonidine and one third will receive ophthalmic buffered saline (placebo).

Conditions

  • Graft Versus Host Disease
  • Ocular Surface Disease
  • oGVHD
  • Ocular Graft vs Host Disease
  • Brimonidine Tartrate
  • Lubricant Eye Drops
  • Ophthalmic Solutions
  • Graft vs Host Disease

Interventions

DRUG

Brimonidine Tartrate

Brimonidine Tartrate Nanoemulsion Eye Drops given 2 times a day for 12 weeks.

DRUG

Placebos

Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-23
Primary Completion
2020-04-30
Completion
2020-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03591874 on ClinicalTrials.gov