NCT03992482

IVIG-eye Drops Treatment for Dry Eye Disease

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Sandeep Jain, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Intravenous Immune Globulin (IVIG)	Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks
DRUG	Placebo	Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-08-02
• Completion: 2019-08-02
• First posted: 2019-06-20
• Last updated: 2020-04-10
• Results posted: 2020-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study