Status:
WITHDRAWN
OSIG-eye Drops Treatment for Dry Eye Disease
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Able to Sign and date the informed consent form approved by the Institutional Review Board (IRB)
- ≥ 18 years of age
- Patient reported dry eye-related ocular symptoms for at least 3 months before the Screening Visit and use or desire to use artificial tears, ointments or dry eye treatments in the 2 weeks preceding the screening visit
- Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the subject and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a subject mentions she suspects she may be pregnant after being enrolled, another pregnancy test will be administered. If the test is positive, she will be discontinued from the study immediately.
- Be willing/able to return for all study visits and to follow instructions from the study investigator and his staff
Exclusion
- Inability to provide informed consent.
- Vulnerable populations, such as neonates, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
- Contact lens wear within two weeks of baseline visit.
Key Trial Info
Start Date :
May 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04510428
Start Date
May 15 2023
End Date
January 20 2024
Last Update
May 23 2023
Active Locations (1)
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1
Illinois Eye and Ear Infirmary, University of Illinois
Chicago, Illinois, United States, 60612