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Immunoglobulin

Ocular Surface Immune Globulin (OSIG) for Dry Eye Syndrome

Phase 2
Waitlist Available
Led By Sandeep Jain, MD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial is designed to study the efficacy of using OSIG eye drops to treat Dry Eye Disease. 40 subjects will be given either the eye drops or a placebo, and the results will be compared after 8 weeks.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean reduction in Dry Eye Disease (DED) symptoms as measured by the Ocular surface disease index (OSDI) score at 8 week, compared to day 1 (pre-dose)
Mean reduction in Epitheliopathy at week 8, compared to day 1 (pre-dose), as measured by corneal staining score using National Eye Institute (NEI) grading scale.
Other outcome measures
Visual Analog Scale at 8 Weeks (56 Days)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OSIG-Eye DropExperimental Treatment1 Intervention
Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks
Group II: Placebo-Eye DropPlacebo Group1 Intervention
Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
610 Previous Clinical Trials
1,559,459 Total Patients Enrolled
Sandeep Jain, MDPrincipal InvestigatorUniversity of Illinois at Chicago
4 Previous Clinical Trials
147 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted its blessing to Ocular Surface Immune Globulin (OSIG)?

"Due to lacking evidence in terms of efficacy, the safety rating for Ocular Surface Immune Globulin (OSIG) is a 2 on our team's scale. However, there are some data points that indicate it might be relatively safe."

Answered by AI

What is the availability of patient enrollment for this trial?

"Clinicaltrials.gov affirms this medical study is not currently open for enrollment, though it was first posted on January 14th 2023 and last edited November 1st 2022. Nevertheless, there are still 139 other trials that have vacancies."

Answered by AI

Who else is applying?

What site did they apply to?
Illinois Eye and Ear Infirmary, University of Illinois
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I currently use serum tears to manage my dry eye condition.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
OSIG-eye Drops Treatment for Dry Eye Disease
Sandeep Jain, MD 2023. "OSIG-eye Drops Treatment for Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04510428.
~0 spots leftby May 2025
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