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

NCT02975557 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-11-08

Study results available
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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

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.

Sponsors & Collaborators

  • Ocugen

    collaborator INDUSTRY

  • Sandeep Jain, MD

    lead OTHER

Principal Investigators

  • Sandeep Jain, MD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-04-13
Completion
2017-04-13

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02975557 on ClinicalTrials.gov