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Trial record 2 of 6 for:    sandeep jain

rhDNase Eye Drops in Patients With Ocular Graft-Vs.-Host Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Sandeep Jain, University of Illinois at Chicago
Sponsor:
Collaborators:
Genentech, Inc.
National Eye Institute (NEI)
Information provided by (Responsible Party):
Sandeep Jain, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT02702518
First received: March 3, 2016
Last updated: October 3, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to evaluate the tolerability and preliminary efficacy of rhDNase I eye drops in patients with ocular Graft-vs.-Host disease (oGVHD).

Condition Intervention Phase
Ocular Graft vs Host Disease Dry Eye Drug: rhDNase I Drug: Vehicle Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/II Randomized Placebo-Controlled, Double-Blind, Single-Center, Tolerability and Preliminary Efficacy Clinical Trial of Recombinant Human Deoxyribonuclease (rhDNase) Eye Drops in Patients With Ocular Graft-Vs.-Host Disease

Resource links provided by NLM:


Further study details as provided by Sandeep Jain, University of Illinois at Chicago:

Primary Outcome Measures:
  • Mean reduction in corneal staining score as measured by Rose Bengal dye staining. [ Time Frame: Between baseline and at 8 weeks of treatment ]

Secondary Outcome Measures:
  • The change in the Ocular Surface Disease Index (OSDI) score [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in tear secretion as measured by Schirmer I test [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in conjunctival surface staining score as measured by Rose Bengal dye staining [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • The change in subjective ocular surface redness score (OR) using the validated bulbar redness (VBR) grading scale [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in frequency of administration of artificial tears or concomitant eye drops [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in number of corneal filaments (slit-lamp examination) [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in amount of mucoid films (slit-lamp examination) [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Clinical Global Impression (CGI) of change in symptoms from baseline (physician's rating) [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Subject Global Assessment (SGA) of overall change from baseline (subject's rating) [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in Non-Invasive Keratograph Tear Break-Up Time (NIKBUT) [ Time Frame: Between baseline, 4 weeks and 8 weeks of treatment ]
  • Change in Tear Meniscus Height (TMH) [ Time Frame: Between baseline, 4 weeks and 8 weeks of treatment ]
  • Change in Keratograph Ocular Bulbar Redness Score [ Time Frame: Between baseline, 4 weeks and 8 weeks of treatment ]
  • Change in MMP-9 Protein Detection [ Time Frame: Between baseline, 4 weeks and 8 weeks of treatment ]
  • Change in Tear Fluid Osmolarity [ Time Frame: Between baseline, 4 weeks and 8 weeks of treatment ]
  • Change in eDNA abundance in tear fluid [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in tear fluid cell count [ Time Frame: Between baseline and at 8 weeks of treatment ]

Other Outcome Measures:
  • The change in the test substance tolerance using visual analogue scale [ Time Frame: Between Day 1 (post-dose) and at weeks 2, 4, 6 and 8 ]

Estimated Enrollment: 72
Study Start Date: April 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rhDNase I
rhDNase I 0.1% eye drops 4 times a day for 8 weeks
Drug: rhDNase I
rhDNase I, 0.1% eye drops 4 times a day for 8 weeks
Other Name: Pulmozyme
Placebo Comparator: Vehicle
Drug vehicle eye drops 4 times a day for 8 weeks
Drug: Vehicle
Drug vehicle 4 times a day for 8 weeks
Other Name: Placebo

  Eligibility

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

Inclusion Criteria:

  • The PI and other members of International Chronic Ocular GVHD Consensus Group have established the consensus diagnostic criteria and classification for chronic ocular GVHD.

Table 1: Severity scale in chronic ocular GVHD

Severity scores (points) Schirmer's test (mm) CFS (points) OSDI (points) Conj (points) 0 >15 0 <13 None

  1. 11-15 <2 13-22 Mild/Moderate
  2. 6-10 2-3 23-32 Severe
  3. ≤5 ≥4 ≥33

CFS; corneal fluorescein staining, OSDI; Ocular Surface Disease Index. Conj; conjunctival injection. Severity classification; Total score (points); (Schirmer's test score+ CFS score+ OSDI score+ Conj injection score) = None;0-4, Mild/Moderate; 5-8, Severe, 9-11.

Table 2: Diagnosis of chronic ocular GVHD None (points) Probable GVHD (points) Definite GVHD (points) Systemic GVHD(−) 0-5 6-7 ≥8 Systemic GVHD(+) 0-3 4-5 ≥6

Based on these criteria (Tables 1 and 2),40 patients with definite ocular GVHD will be enrolled. Additionally, all of the following criteria should be met to be eligible for the study:

  • Aged 18 years or older.
  • Capable of giving informed consent and does provide informed consent.
  • Schirmer I <10
  • Corneal/ conjunctival (Rose Bengal) staining ≥1
  • Ocular symptoms must be considered as annoying or activity limiting (OSDI ≥13; mild).
  • 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.

Exclusion Criteria:

  • Subjects will not be eligible for the study if any of the following criteria are met:

    • Allergic to rhDNase I or any similar products, or recipient of rhDNase I eye drops 0.1%.
    • Receiving or have received within 30 days any experimental systemic medication.
    • Active ocular infection or ocular allergies.
    • Any history of eyelid surgery or ocular surgery within the past 3 months.
    • Corneal epithelial defect larger than 1 mm2 in either eye.
    • Have active drug/alcohol dependence or abuse history.
    • Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02702518

Contacts
Contact: Clinical Trial Line 312-918-0900 mun2@uic.edu
Contact: Sandeep Jain, MD 312-996-8936 jainsop@gmail.com

Locations
United States, Illinois
Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Sandeep Jain, MD    312-355-5220    jains@uic.edu   
Principal Investigator: Sandeep Jain, MD         
University of Illinois Eye and Ear Infirmary Recruiting
Chicago, Illinois, United States, 60612
Contact: Sandeep Jain, MD    312-355-5220    jainsop@gmail.com   
Sponsors and Collaborators
University of Illinois at Chicago
Genentech, Inc.
National Eye Institute (NEI)
Investigators
Principal Investigator: Sandeep Jain, MD University of Illinois at Chicago
  More Information

Publications:
Responsible Party: Sandeep Jain, Associate Professor of Ophthalmology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02702518     History of Changes
Other Study ID Numbers: UIC-CNBL-1002
R01EY024966-01A1 ( U.S. NIH Grant/Contract )
Study First Received: March 3, 2016
Last Updated: October 3, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sandeep Jain, University of Illinois at Chicago:
rhDNase I, Pulmozyme, oGVHD, Dry Eye

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 21, 2017