OSIG-eye Drops Treatment for Dry Eye Disease

University of Illinois

Status and phase: Withdrawn; Phase 2

Conditions: Dry Eye

Treatments: Drug: Placebo; Drug: Ocular Surface Immune Globulin (OSIG)

Study type: Interventional

Funder types: Other

Identifiers

NCT04510428

2020-0925

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

OSIG-Eye Drop

Experimental group

Description:

Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks

Treatment:

Drug: Ocular Surface Immune Globulin (OSIG)

Placebo-Eye Drop

Placebo Comparator group

Description:

Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks

Treatment:

Drug: Placebo