Trial Outcomes & Findings for IVIG-eye Drops Treatment for Dry Eye Disease (NCT NCT03992482)

Last Updated: 2020-04-10

Results Overview

Subjects will assess their tolerance to the administration of the test medication (placebo/ study drug), utilizing a Visual Analog Scale (VAS). The VAS is a 100 mm horizontal line with verbal descriptors at either end. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm). The VAS ratings will be completed after administration of the test medication on Day 1 (post-dose), week 4 and week 8.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

27 participants

Primary outcome timeframe

8 Weeks

Results posted on

2020-04-10

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 on 6 May 2019, and the last participant was enrolled on 7 June 2019.

Participant milestones

Participant milestones
Measure	IVIG-Eye Drop Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks	Placebo-Eye Drop Normal Saline Eye Drops (0.9% NaCl) Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks
Overall Study STARTED	13	14
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IVIG-eye Drops Treatment for Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IVIG-Eye Drop n=13 Participants Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks	Placebo-Eye Drop n=14 Participants Normal Saline Eye Drops (0.9% NaCl) Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks	Total n=27 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	65 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 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
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants
Diagnosis Auto-immune tear deficient DED	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Diagnosis ocular GVHD	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Diagnosis Non-autoimmune tear deficient DED	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Diagnosis Meibomian Gland Dysfunction (MGD)	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
OSDI	52.3 units on a scale n=5 Participants	40.9 units on a scale n=7 Participants	43.18 units on a scale n=5 Participants
Corneal Staining	5 units on a scale n=5 Participants	2 units on a scale n=7 Participants	3 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 8 Weeks

Outcome measures

Outcome measures
Measure	IVIG-Eye Drop n=13 Participants Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks	Placebo-Eye Drop n=14 Participants Normal Saline Eye Drops (0.9% NaCl) Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks
Tolerability: The Primary Tolerability Endpoint is the Test Substance Tolerance (Visual Analog Scale) at 8 Weeks (56 Days)	100 score on a scale Interval 100.0 to 100.0	100 score on a scale Interval 100.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and at 8 weeks of treatment

Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and \>33 being severe DED. OSDI=\[(sum of scores for questions answered)×100\]/\[(total questions answered)×4\]

Outcome measures

Outcome measures
Measure	IVIG-Eye Drop n=13 Participants Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks	Placebo-Eye Drop n=14 Participants Normal Saline Eye Drops (0.9% NaCl) Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks
The Change in the Ocular Surface Disease Index (OSDI) Which is a Patient's Subjective Rating Scale	-20.9 score on a scale Interval -24.43 to -15.0	0.00 score on a scale Interval -12.08 to 4.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and at 8 weeks of treatment

Corneal staining score as measured by Lissamine Green dye staining using National Eye Institute (NEI) grading scale. Dye was applied to each eye and a slit lamp was used to observe corneal staining. NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores with a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with Lissamine dye defined as a score of 0 indicating the best outcome.

Outcome measures

Outcome measures
Measure	IVIG-Eye Drop n=26 Eye Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks	Placebo-Eye Drop n=28 Eye Normal Saline Eye Drops (0.9% NaCl) Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks
Change in Corneal Staining Score as Measured by Lissamine Dye Staining	-1.50 score on a scale Interval -3.5 to 0.0	0.00 score on a scale Interval 0.0 to 1.25

Adverse Events

IVIG-Eye Drop

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo-Eye Drop

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IVIG-Eye Drop n=13 participants at risk Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks Intravenous Immune Globulin (IVIG): Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks	Placebo-Eye Drop n=14 participants at risk Normal Saline Eye Drops (0.9% NaCl) Placebo: Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks
Eye disorders Ocular discomfort	15.4% 2/13 • Between baseline and 8-weeks of treatment	35.7% 5/14 • Between baseline and 8-weeks of treatment
Eye disorders Pain	0.00% 0/13 • Between baseline and 8-weeks of treatment	7.1% 1/14 • Between baseline and 8-weeks of treatment
Eye disorders Tearing	0.00% 0/13 • Between baseline and 8-weeks of treatment	14.3% 2/14 • Between baseline and 8-weeks of treatment
Eye disorders Blurring of vision	15.4% 2/13 • Between baseline and 8-weeks of treatment	28.6% 4/14 • Between baseline and 8-weeks of treatment
Eye disorders Light sensitivity	7.7% 1/13 • Between baseline and 8-weeks of treatment	35.7% 5/14 • Between baseline and 8-weeks of treatment
Eye disorders Dryness	15.4% 2/13 • Between baseline and 8-weeks of treatment	28.6% 4/14 • Between baseline and 8-weeks of treatment
Eye disorders Redness	0.00% 0/13 • Between baseline and 8-weeks of treatment	14.3% 2/14 • Between baseline and 8-weeks of treatment

Additional Information

Dr. Sandeep Jain

University of Illinois Chicago

Phone: 312-996-4476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place