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

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ClinicalTrials.gov Identifier: NCT02975557
Recruitment Status : Terminated (Slow accrual of subjects. May take longer than expected to complete the trial.)
First Posted : November 29, 2016
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Sandeep Jain, University of Illinois at Chicago

Brief 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 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.


Condition or disease Intervention/treatment Phase
Dry Eye Ocular Graft vs Host Disease Meibomian Gland Dysfunction Drug: Brimonidine 0.15% Drug: Brimonidine 0.075% Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : May 2016
Actual Primary Completion Date : March 28, 2017
Actual Study Completion Date : March 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Brimonidine 0.15%
Brimonidine 0.15% eye drops 2 times a day for 12 weeks
Drug: Brimonidine 0.15%
Brimonidine 0.15% eye drops 2 times a day for 12 weeks
Other Name: Alphagan P

Active Comparator: 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: 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.
Other Name: Alphagan P

Placebo Comparator: Placebo
Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 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.
Other Name: Refresh plus Artificial Tear




Primary Outcome Measures :
  1. Mean reduction in OSDI (Ocular Surface Disease Index) score [ Time Frame: Between baseline and 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Change in ocular surface/lid margin staining score as measured by Rose Bengal/Fluorescein dye staining [ Time Frame: Between baseline and 12 weeks of treatment ]
  2. Change in tear secretion as measured by Schirmer I test [ Time Frame: Between baseline and 12 weeks of treatment ]
  3. Change in Keratograph Ocular Bulbar Redness Score [ Time Frame: Between baseline, 3 Weeks, 6 Weeks, 9 Weeks, and 12 Weeks of treatment ]
  4. Change in lid margin vascularization/telangiectasia [ Time Frame: Between baseline, 3 Weeks, 6 Weeks, 9 Weeks, 12 Weeks, and 15 Weeks ]
  5. Clinical Global Impression (CGI) of change in symptoms from baseline (physician's rating) [ Time Frame: Between 3 Weeks, 6 Weeks, 9 Weeks, 12 Weeks, and 15 Weeks ]
  6. Subject Global Assessment (SGA) of overall change from baseline (subject's rating) [ Time Frame: Between baseline and 3 Weeks, 6 Weeks, 9 Weeks, 12 Weeks, 15 Weeks ]

Other Outcome Measures:
  1. Number of visible meibomian gland orifices, and alteration (capping/ obliteration) of the orifices [ Time Frame: Baseline, 3 Weeks, 6 Weeks, 9 Weeks, and 12 Weeks ]
  2. Meibum expression [ Time Frame: Baseline, 3 Weeks, 6 Weeks, 9 Weeks, 12 Weeks, and 15 Weeks ]
  3. Quality of expressed meibum [ Time Frame: Baseline, 3 Weeks, 6 Weeks, 9 Weeks, 12 Weeks, and 15 Weeks ]
  4. Eyelid margin changes- thickening, hyperkeratinization, irregularity and muco-cutaneous junction shift [ Time Frame: Between baseline, 3 Weeks, 6 Weeks, 9 Weeks, 12 Weeks, and 15 Weeks ]
  5. Ocular surface redness score [ Time Frame: Baseline, 3 Weeks, 6 Weeks, 9 Weeks, 12 Weeks, and 15 Weeks ]
  6. Change in Non-Invasive Keratograph Tear Break-Up Time [ Time Frame: Between baseline, 3 Weeks, 6 Weeks, 9 Weeks, and 12 Weeks ]
  7. Change in Tear Meniscus Height [ Time Frame: Between baseline, 3 Weeks, 6 Weeks, 9 Weeks, and 12 Weeks ]
  8. Change in Tear Fluid Osmolarity [ Time Frame: Between baseline, 6 Weeks and 12 Weeks ]
  9. Change in Lipid Layer Thickness [ Time Frame: Between baseline, 6 Weeks and 12 Weeks ]
  10. Change in Meibomian Gland Drop-Out [ Time Frame: Between baseline, 6 Weeks and 12 Weeks ]
  11. Change in partial or complete blink [ Time Frame: Between baseline, 6 Weeks and 12 Weeks ]
  12. Change in frequency of blinks [ Time Frame: Between baseline, 6 Weeks and 12 Weeks ]
  13. Visual acuity change [ Time Frame: Between baseline, 3 Weeks, 6 Weeks, 9 Weeks, 12 Weeks, and 15 Weeks ]
  14. Change in frequency of administration of artificial tears or concomitant eye drops [ Time Frame: Between baseline, 3 Weeks, 6 Weeks, 9 Weeks, 12 Weeks, and 15 Weeks ]
  15. Measurement of number and type of cells (particularly leukocytes) in tear film [ Time Frame: Baseline, 3 Weeks, 6 Weeks, 9 Weeks, and 12 Weeks ]
  16. The change in the test substance tolerance [ Time Frame: Between Day 1 (post-dose) and at weeks 3, 6, 9 and 12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975557


Locations
United States, Illinois
Illinois Eye and Ear Infirmary, University of Illinois
Chicago, Illinois, United States, 60612
Translational Clinic of Corneal Neurobiology Laboratory, Illinois Eye and Ear Infirmary, University of Illinois
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Sandeep Jain, MD University of Illinois at Chicago

Additional Information:
Publications:
Responsible Party: Sandeep Jain, Associate Professor of Ophthalmology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02975557     History of Changes
Other Study ID Numbers: UIC-CNBL-2002
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sandeep Jain, University of Illinois at Chicago:
Brimonidine
Dry Eye
oGVHD
MGD

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Ophthalmic Solutions
Brimonidine Tartrate
Lubricant Eye Drops
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs