IVIG-eye Drops Treatment for Dry Eye Disease

NCT03992482 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2019-0263
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dry Eye

Keywords

Dry Eye; Intravenous Immunoglobulin (IVIG) Eye Drops; Treatment; ocular Graft-vs-Host Disease (oGVHD)

Outcome Measures

Primary Outcomes (1)

• Tolerability: The Primary Tolerability Endpoint is the Test Substance Tolerance (Visual Analog Scale) at 8 Weeks (56 Days)

  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 Outcomes (2)

• The Change in the Ocular Surface Disease Index (OSDI) Which is a Patient's Subjective Rating Scale

  Between baseline and at 8 weeks of treatment

• Change in Corneal Staining Score as Measured by Lissamine Dye Staining

  Between baseline and at 8 weeks of treatment

Study Arms (2)

IVIG-Eye Drop

EXPERIMENTAL

Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks

Drug: Intravenous Immune Globulin (IVIG)

Placebo-Eye Drop

PLACEBO COMPARATOR

Normal Saline Eye Drops (0.9% NaCl)

Drug: Placebo

Interventions

Intravenous Immune Globulin (IVIG) DRUG

Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks

IVIG-Eye Drop

Placebo DRUG

Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks

Placebo-Eye Drop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign and date the informed consent form approved by the Institutional Review Board (IRB)
• ≥ 18 years of age
• Demonstrate at least any 2 of the following signs in the same eye or a sign and symptom.
• Conjunctival staining present ≥ 1 (out of possible score of 6 per eye)
• Corneal staining present ≥ 2 (out of a possible score of 15 per eye)
• Tear film break up time (TFBUT) ≤ 7 seconds
• Schirmer's test ≥ 0 to ≤ 9 mm/5min
• Superior Limbic Keratoconjunctivitis (SLK) pattern staining ≥ 1
• Meiboscale grade ≥ 2
• Validated Bulbar Redness ≥ 40
• Demonstrate symptoms of dry eye disease Ocular Surface Disease Index (OSDI) score of at least ≥ 13.
• Demonstrate Symptom Intensity Assessment of ≥ 3.
• 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
• Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye
• 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

You may not qualify if:

• Allergic to IVIG or any similar products, or excipients of IVIG eye drops 4 mg/ml.
• Use of contact lenses within the last 2-weeks prior to the baseline Visit.
• Use of Allogenic serum or plasma eye drops within the last 2-weeks prior to the baseline Visit.
• Unwilling to commit to no use of contact lenses for the duration of the study.
• Pregnant or nursing/lactating
• Participation in a study of an investigational drug or device within the 30 days preceding the Screening Visit
• 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)
• A cognitive or psychiatric deficit that precludes informed consent or ability to perform
• Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
• Have active drug/alcohol dependence or abuse.
• The corneal epithelial defect is larger than 1 mm2 in either eye.
• Active ocular infection or ocular allergies.

Sponsors & Collaborators

• Sandeep Jain, MD: lead

Study Sites (1)

Illinois Eye and Ear Infirmary

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• Martin-Nares E, Hernandez-Molina G. Novel autoantibodies in Sjogren's syndrome: A comprehensive review. Autoimmun Rev. 2019 Feb;18(2):192-198. doi: 10.1016/j.autrev.2018.09.003. Epub 2018 Dec 18.

  PMID: 30572138 BACKGROUND

• Dourmishev LA, Guleva DV, Miteva LG. Intravenous Immunoglobulins: Mode of Action and Indications in Autoimmune and Inflammatory Dermatoses. Int J Inflam. 2016;2016:3523057. doi: 10.1155/2016/3523057. Epub 2016 Jan 18.

  PMID: 26885437 BACKGROUND

• Mun C, Gulati S, Tibrewal S, Chen YF, An S, Surenkhuu B, Raju I, Buwick M, Ahn A, Kwon JE, Atassi N, Pradeep A, Rondelli D, Jain S. A Phase I/II Placebo-Controlled Randomized Pilot Clinical Trial of Recombinant Deoxyribonuclease (DNase) Eye Drops Use in Patients With Dry Eye Disease. Transl Vis Sci Technol. 2019 May 2;8(3):10. doi: 10.1167/tvst.8.3.10. eCollection 2019 May.

  PMID: 31110911 BACKGROUND

• An S, Raju I, Surenkhuu B, Kwon JE, Gulati S, Karaman M, Pradeep A, Sinha S, Mun C, Jain S. Neutrophil extracellular traps (NETs) contribute to pathological changes of ocular graft-vs.-host disease (oGVHD) dry eye: Implications for novel biomarkers and therapeutic strategies. Ocul Surf. 2019 Jul;17(3):589-614. doi: 10.1016/j.jtos.2019.03.010. Epub 2019 Apr 6.

  PMID: 30965123 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Outcomes of this clinical trial shouldn't be over-interpreted for benefit. Accurate assessment of therapeutic implications of IVIG eye drops will only be possible after adequately powered definitive pivotal trials. Small sample size is a limitation.

Results Point of Contact

• Title: Dr. Sandeep Jain
• Organization: University of Illinois Chicago

jains@uic.edu

312-996-4476

Study Officials

• Sandeep Jain, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 20, 2019
• Study Start: May 1, 2019
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: April 10, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)