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OSIG-eye Drops Treatment for Dry Eye Disease

NCT04510428 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Sandeep Jain, MD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2023-11-30
Completion
2024-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04510428 on ClinicalTrials.gov