Trial Outcomes & Findings for Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD) (NCT NCT02975557)

Last Updated: 2019-11-08

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-11-08

Participant Flow

Subjects were recruited from the clinical practice of the investigator at the time of their routine eye examination visit. The clinical practice is located in the Illinois Eye and Ear Infirmary (EEI), the University of Illinois at Chicago (UIC). The first participant was enrolled in May 2016, and the last participant was enrolled in February 2017.

Participant milestones

Participant milestones
Measure	Brimonidine 0.15% Brimonidine 0.15% eye drops 2 times a day for 12 weeks Brimonidine 0.15%: Brimonidine 0.15% eye drops 2 times a day for 12 weeks	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. 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.	Placebo Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks. Placebo: Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.
Overall Study STARTED	4	5	6
Overall Study COMPLETED	3	2	5
Overall Study NOT COMPLETED	1	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brimonidine 0.15% n=4 Participants Brimonidine 0.15% eye drops 2 times a day for 12 weeks Brimonidine 0.15%: Brimonidine 0.15% eye drops 2 times a day for 12 weeks	Brimonidine 0.075% n=5 Participants 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. 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.	Placebo n=6 Participants Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks. Placebo: Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	15 participants n=4 Participants
Ocular Surface Disease Index (OSDI)	48.4 units on a scale STANDARD_DEVIATION 8.32 • n=5 Participants	61.36 units on a scale STANDARD_DEVIATION 22.42 • n=7 Participants	56.03 units on a scale STANDARD_DEVIATION 22.99 • n=5 Participants	55.72 units on a scale STANDARD_DEVIATION 20.28 • n=4 Participants
Schirmer I Test	6.75 mm STANDARD_DEVIATION 8.42 • n=5 Participants	2 mm STANDARD_DEVIATION 4.47 • n=7 Participants	0.33 mm STANDARD_DEVIATION 0.74 • n=5 Participants	1.4 mm STANDARD_DEVIATION 2.60 • n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The sponsor terminated the research early citing slow accrual of subjects and ceased sponsorship. At this point, the available valid sample size was 11 subjects at 12 weeks for assessing the tolerability at 12 weeks.

Outcome measures

Outcome measures
Measure	Brimonidine 0.15% n=3 Participants Brimonidine 0.15% eye drops 2 times a day for 12 weeks Brimonidine 0.15%: Brimonidine 0.15% eye drops 2 times a day for 12 weeks	Brimonidine 0.075% n=2 Participants 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. 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.	Placebo n=6 Participants Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks. Placebo: Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.
Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks. Tolerability (100%)	3 Participants	1 Participants	4 Participants
Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks. Tolerability (95%)	0 Participants	0 Participants	1 Participants
Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks. Tolerability (90%)	0 Participants	1 Participants	1 Participants

Adverse Events

Brimonidine 0.15%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brimonidine 0.075%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sandeep Jain

Ophthalmology and Visual Sciences, University of Illinois, Chicago, IL

Phone: 312-996-4476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place