OSIG-eye Drops Treatment for Dry Eye Disease
OSIG-eye Drops Treatment for Dry Eye Disease
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.
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.