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
Overview
- Phase
- Phase 1
- Intervention
- Intravenous Immune Globulin (IVIG)
- Conditions
- Dry Eye
- Sponsor
- Sandeep Jain, MD
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Tolerability: The Primary Tolerability Endpoint is the Test Substance Tolerance (Visual Analog Scale) at 8 Weeks (56 Days)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Sandeep Jain, MD
Professor
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
IVIG-Eye Drop
Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks
Intervention: Intravenous Immune Globulin (IVIG)
Placebo-Eye Drop
Normal Saline Eye Drops (0.9% NaCl)
Intervention: Placebo
Outcomes
Primary Outcomes
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.