IVIG-eye Drops Treatment for Dry Eye Disease

April 8, 2020 updated by: Sandeep Jain, MD

A Phase I/II Randomized, Placebo-controlled, Double-Blind, Single-Center, Tolerability and Preliminary Efficacy Clinical Trial of Intravenous Immunoglobulin (IVIG) Eye Drops in Patients With Dry Eye Disease

The main objective of this study is to establish whether patients with Dry Eye Disease are able to safely tolerate receiving Intravenous Immunoglobulin (IVIG) eye drops two times a day for eight weeks (primary 'safety and tolerability' objective). The exploratory objective is to investigate the preliminary efficacy of the use of IVIG eye drops in treating Dry Eye Disease (exploratory efficacy objective) to estimate the effectiveness of the trial intervention and collecting data to inform the design of a future definitive trial.

This will be a Randomized controlled trial, in which a total of 28 subjects will be enrolled at 1 clinical site. Subjects will be randomly assigned to one of two groups (#1, #2), with 14 subjects per group. One group will be given placebo (Normal saline eye drops) and the other group will be given eye drops containing the study drug (IVIG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Illinois Eye and Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Sign and date the informed consent form approved by the Institutional Review Board (IRB)
  2. ≥ 18 years of age

  3. Demonstrate at least any 2 of the following signs in the same eye or a sign and symptom.

    1. Conjunctival staining present ≥ 1 (out of possible score of 6 per eye)
    2. Corneal staining present ≥ 2 (out of a possible score of 15 per eye)
    3. Tear film break up time (TFBUT) ≤ 7 seconds
    4. Schirmer's test ≥ 0 to ≤ 9 mm/5min
    5. Superior Limbic Keratoconjunctivitis (SLK) pattern staining ≥ 1
    6. Meiboscale grade ≥ 2
    7. Validated Bulbar Redness ≥ 40
    8. Demonstrate symptoms of dry eye disease Ocular Surface Disease Index (OSDI) score of at least ≥ 13.
    9. Demonstrate Symptom Intensity Assessment of ≥ 3.
  4. Patient reported dry eye-related ocular symptoms for at least 6 months before the Screening Visit and use or desire to use artificial tears on average 2 times per day in the 2 weeks preceding the screening visit
  5. Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye
  6. Women of child-bearing potential must agree to use a reliable method of contraception during study participation and must demonstrate a negative pregnancy test at the Screening Visit
  7. Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff
  8. Ocular Surface Wash Anti-Citrullinated Protein Antibody (ACPA) value of > 4.4 units in either eye at any time in the past.

Exclusion Criteria:

  1. Allergic to IVIG or any similar products, or excipients of IVIG eye drops 4 mg/ml.
  2. Use of contact lenses within the last 2-weeks prior to the baseline Visit.
  3. Use of Allogenic serum or plasma eye drops within the last 2-weeks prior to the baseline Visit.
  4. Unwilling to commit to no use of contact lenses for the duration of the study.
  5. Pregnant or nursing/lactating
  6. Participation in a study of an investigational drug or device within the 30 days preceding the Screening Visit

  7. Current diagnosis of any of the following ocular conditions:

    i) Acute allergic conjunctivitis ii) Active infection (e.g. bacterial, viral, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids) iii) Active intraocular inflammation (e.g., retinitis, choroiditis, uveitis)

  8. A cognitive or psychiatric deficit that precludes informed consent or ability to perform
  9. Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
  10. Have active drug/alcohol dependence or abuse.
  11. The corneal epithelial defect is larger than 1 mm2 in either eye.
  12. Active ocular infection or ocular allergies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IVIG-Eye Drop
Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks
Drug: Intravenous Immune Globulin (IVIG)
Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks
Placebo Comparator: Placebo-Eye Drop
Normal Saline Eye Drops (0.9% NaCl)
Drug: Placebo
Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability: The Primary Tolerability Endpoint is the Test Substance Tolerance (Visual Analog Scale) at 8 Weeks (56 Days)
Time Frame: 8 Weeks
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.
8 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in the Ocular Surface Disease Index (OSDI) Which is a Patient's Subjective Rating Scale
Time Frame: 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]
Between baseline and at 8 weeks of treatment
Change in Corneal Staining Score as Measured by Lissamine Dye Staining
Time Frame: 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.
Between baseline and at 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandeep Jain, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

August 2, 2019

Study Completion (Actual)

August 2, 2019

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (Actual)

June 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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