Clinical trial NCT04510428: OSIG-eye Drops Treatment for Dry Eye Disease
Official title: A Phase II Randomized Placebo-Controlled, Double Blind, Single-Center, Tolerability and Efficacy Clinical Trial of Ocular Surface Immunoglobulin (OSIG) Eye Drops In Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Able to Sign and date the informed consent form approved by the Institutional Review Board (IRB)
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:

1. Inability to provide informed consent.
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.

Primary outcomes:
measure: 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.
timeFrame: 8 Weeks
measure: 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)
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
measure: Visual Analog Scale at 8 Weeks (56 Days)
timeFrame: 8 Weeks
Locations:
city: Chicago
country: United States
facility: Illinois Eye and Ear Infirmary, University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sandeep Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: