Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-05-15
2024-01-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OSIG-Eye Drop
Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks
Ocular Surface Immune Globulin (OSIG)
Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks
Placebo-Eye Drop
Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks
Placebo
Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks
Interventions
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Ocular Surface Immune Globulin (OSIG)
Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks
Placebo
Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks
Eligibility Criteria
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Inclusion Criteria
2. ≥ 18 years of age
3. 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
4. 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.
5. Be willing/able to return for all study visits and to follow instructions from the study investigator and his staff
Exclusion Criteria
2. Vulnerable populations, such as neonates, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
3. Contact lens wear within two weeks of baseline visit.
18 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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Sandeep Jain, MD
Professor
Principal Investigators
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Sandeep Jain, MD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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Illinois Eye and Ear Infirmary, University of Illinois
Chicago, Illinois, United States
Countries
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Other Identifiers
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2020-0925
Identifier Type: -
Identifier Source: org_study_id
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