NCT04510428

OSIG-eye Drops Treatment for Dry Eye Disease

A Phase II Randomized Placebo-Controlled, Double Blind, Single-Center, Tolerability and Efficacy Clinical Trial of Ocular Surface Immunoglobulin (OSIG) Eye Drops In Patients With Dry Eye Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess the clinical and mechanistic effect of using Ocular surface immunoglobulin (OSIG) eye drops for treating Dry Eye Disease. Therefore, the investigator will perform a prospective, phase II, randomized, placebo-controlled, double-masked, tolerability and efficacy clinical trial using OSIG-eye drops in patients with Dry Eye Disease. This clinical trial will be powered to detect efficacy of the treatment. This will be a Randomized controlled trial, in which a total of 40 subjects will be enrolled at one clinical site. Subjects will be randomly assigned to one of two groups (#1, #2), with 20 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 (OSIG). Treatment will be for eight weeks.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Ocular Surface Immune Globulin (OSIG)	Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks
DRUG	Placebo	Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks

Timeline

• Start date: 2023-05-15
• Primary completion: 2023-11-30
• Completion: 2024-01-20
• First posted: 2020-08-12
• Last updated: 2023-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study