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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
Summary
This trial tests special eye drops with an immune protein to help people with Dry Eye Disease by reducing irritation and improving tear quality.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,136 Total Patients Enrolled
Sandeep Jain, MDPrincipal InvestigatorUniversity of Illinois at Chicago
4 Previous Clinical Trials
147 Total Patients Enrolled
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