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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 : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sandeep Jain, MD, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE August 6, 2020
First Posted Date  ICMJE August 12, 2020
Last Update Posted Date August 2, 2021
Estimated Study Start Date  ICMJE September 14, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2020)
  • 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.
  • 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]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 11, 2020)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE OSIG-eye Drops Treatment for Dry Eye Disease
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks
Study Arms  ICMJE
  • Experimental: OSIG-Eye Drop
    Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks
    Intervention: Drug: Ocular Surface Immune Globulin (OSIG)
  • Placebo Comparator: Placebo-Eye Drop
    Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 11, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sandeep Jain, MD 312-355-5220 jains@uic.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04510428
Other Study ID Numbers  ICMJE 2020-0925
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sandeep Jain, MD, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandeep Jain, MD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP