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Trial record 8 of 156 for:    Brimonidine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Results First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Ocugen
Information provided by (Responsible Party):
Sandeep Jain, MD, 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 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.


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

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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)
Actual Study Start Date : May 2016
Actual Primary Completion Date : April 13, 2017
Actual Study Completion Date : April 13, 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. Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks. [ Time Frame: 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).



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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
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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
Sandeep Jain, MD
Ocugen
Investigators
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Principal Investigator: Sandeep Jain, MD University of Illinois at Chicago
  Study Documents (Full-Text)

Documents provided by Sandeep Jain, MD, University of Illinois at Chicago:
Informed Consent Form  [PDF] February 10, 2017


Additional Information:
Publications:
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Responsible Party: Sandeep Jain, MD, Professor of Ophthalmology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02975557    
Other Study ID Numbers: 2015-0278
First Posted: November 29, 2016    Key Record Dates
Results First Posted: November 8, 2019
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sandeep Jain, MD, University of Illinois at Chicago:
Brimonidine
Dry Eye
oGVHD
MGD
Additional relevant MeSH terms:
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Brimonidine Tartrate
Graft vs Host Disease
Immune System Diseases
Ophthalmic Solutions
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