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OSIG-eye Drops Treatment for Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT04510428
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Sandeep Jain, MD, University of Illinois at Chicago

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.


Condition or disease Intervention/treatment Phase
Dry Eye Drug: Ocular Surface Immune Globulin (OSIG) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 30, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: OSIG-Eye Drop
Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks
Drug: 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 Comparator: Placebo-Eye Drop
Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks
Drug: Placebo
Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks




Primary Outcome Measures :
  1. 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. [ Time Frame: 8 Weeks ]
    Corneal staining score as measured by Lissamine Green dye staining using National Eye Institute (NEI) grading scale. Dye is applied to each eye and a slit lamp is used to observe corneal staining. NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores with a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with Lissamine dye defined as a score of 0 indicating the best outcome.

  2. 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) [ Time Frame: 8 Weeks ]
    Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and >33 being severe DED. OSDI=[(sum of scores for questions answered)×100]/[(total questions answered)×4]


Other Outcome Measures:
  1. Visual Analog Scale at 8 Weeks (56 Days) [ Time Frame: 8 Weeks ]
    Subjects will assess their tolerance to the administration of the test medication (placebo/ study drug), utilizing a Visual Analog Scale (VAS). The VAS is a 100 mm horizontal line with verbal descriptors at either end. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm). The VAS ratings will be completed after administration of the test medication on Day 1 (post-dose), week 4 and week 8.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510428


Contacts
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Contact: Sandeep Jain, MD 312-355-5220 jains@uic.edu

Locations
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United States, Illinois
Illinois Eye and Ear Infirmary, University of Illinois
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Sandeep Jain, MD
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Responsible Party: Sandeep Jain, MD, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04510428    
Other Study ID Numbers: 2020-0925
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs