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

Primary Purpose

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

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Brimonidine 0.15%

Brimonidine 0.075%

Placebo

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Brimonidine, Dry Eye, oGVHD, MGD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 18 years or older.
Capable of giving informed consent and does provide informed consent.
Diagnosis of Meibomian Gland Disease
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:

Allergic to Brimonidine or any similar products, or excipients of Brimonidine
Currently receiving any Brimonidine preparation as a part of glaucoma management
Receiving or have received within 30 days any experimental systemic medication.
Active ocular infection or ocular allergies.
Any history of eyelid surgery or ocular surgery within the past 3 months.
Corneal epithelial defect larger than 1 mm2 in either eye.
Have active drug/alcohol dependence or abuse history.
Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

Sites / Locations

Illinois Eye and Ear Infirmary, University of Illinois
Translational Clinic of Corneal Neurobiology Laboratory, Illinois Eye and Ear Infirmary, University of Illinois

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Brimonidine 0.15%

Brimonidine 0.075%

Placebo

Arm Description

Brimonidine 0.15% eye drops 2 times a day for 12 weeks

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.

Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.

Outcomes

Primary Outcome Measures

Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02975557

First Posted

November 21, 2016

Last Updated

November 7, 2019

Sponsor

Sandeep Jain, MD

Collaborators

Ocugen

1. Study Identification

Unique Protocol Identification Number

NCT02975557

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual of subjects. May take longer than expected to complete the trial.

Study Start Date

May 2016 (Actual)

Primary Completion Date

April 13, 2017 (Actual)

Study Completion Date

April 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sandeep Jain, MD

Collaborators

Ocugen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Brimonidine, Dry Eye, oGVHD, MGD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brimonidine 0.15%

Arm Type

Active Comparator

Arm Description

Brimonidine 0.15% eye drops 2 times a day for 12 weeks

Arm Title

Brimonidine 0.075%

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Brimonidine 0.15%

Other Intervention Name(s)

Alphagan P

Intervention Description

Brimonidine 0.15% eye drops 2 times a day for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Brimonidine 0.075%

Other Intervention Name(s)

Alphagan P

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Refresh plus Artificial Tear

Intervention Description

Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.

Primary Outcome Measure Information:

Title

Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks.

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18 years or older. Capable of giving informed consent and does provide informed consent. Diagnosis of Meibomian Gland Disease 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: Allergic to Brimonidine or any similar products, or excipients of Brimonidine Currently receiving any Brimonidine preparation as a part of glaucoma management Receiving or have received within 30 days any experimental systemic medication. Active ocular infection or ocular allergies. Any history of eyelid surgery or ocular surgery within the past 3 months. Corneal epithelial defect larger than 1 mm2 in either eye. Have active drug/alcohol dependence or abuse history. Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandeep Jain, MD

Organizational Affiliation

University of Illinois at Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

Illinois Eye and Ear Infirmary, University of Illinois

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Translational Clinic of Corneal Neurobiology Laboratory, Illinois Eye and Ear Infirmary, University of Illinois

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24255046

Citation

Tibrewal S, Sarkar J, Jassim SH, Gandhi S, Sonawane S, Chaudhary S, Byun YS, Ivanir Y, Hallak J, Horner JH, Newcomb M, Jain S. Tear fluid extracellular DNA: diagnostic and therapeutic implications in dry eye disease. Invest Ophthalmol Vis Sci. 2013 Dec 11;54(13):8051-61. doi: 10.1167/iovs.13-12844.

Results Reference

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PubMed Identifier

23169882

Citation

Sonawane S, Khanolkar V, Namavari A, Chaudhary S, Gandhi S, Tibrewal S, Jassim SH, Shaheen B, Hallak J, Horner JH, Newcomb M, Sarkar J, Jain S. Ocular surface extracellular DNA and nuclease activity imbalance: a new paradigm for inflammation in dry eye disease. Invest Ophthalmol Vis Sci. 2012 Dec 17;53(13):8253-63. doi: 10.1167/iovs.12-10430.

Results Reference

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Links:

URL

http://chicago.medicine.uic.edu/directory/name/sandeep-jain-md-jain/

Description

Principal Investigator description

URL

http://eyecare.uic.edu/clinics/DryEyeandOcularGVHDclinic.shtml

Description

Dry Eye and ocular GVHD Clinic at University of Illinois at Chicago

URL

http://cornealneurobiology.uic.edu/

Description

Corneal Neurobiology Laboratory (National Eye Institute funded)

Learn more about this trial

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

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