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

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ClinicalTrials.gov Identifier: NCT02702518
Recruitment Status : Terminated (The DSMB committee recommended closing the trial because of the COVID-19 risk in this "at-risk" oGVHD population if they came for study visits.)
First Posted : March 8, 2016
Results First Posted : August 10, 2021
Last Update Posted : September 5, 2021
Sponsor:
Collaborators:
Genentech, Inc.
National Eye Institute (NEI)
Information provided by (Responsible Party):
Sandeep Jain, MD, University of Illinois at Chicago

Brief Summary:
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 or disease Intervention/treatment Phase
Ocular Graft vs Host Disease Dry Eye Drug: rhDNase I Drug: Vehicle Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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
Study Start Date : April 2016
Actual Primary Completion Date : April 8, 2020
Actual Study Completion Date : April 8, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The Change in the Corneal Surface Staining as Measured by Dye Staining Within Groups. [ Time Frame: Between baseline and at 8 weeks of treatment ]
    Corneal staining score as measured by dye staining using National Eye Institute (NEI) grading scale. Dye was applied to each eye and a slit lamp was 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 dye defined as a score of 0 indicating the best outcome.


Secondary Outcome Measures :
  1. The Change in Ocular Surface Disease Index (OSDI) Score Within Groups [ Time Frame: Between baseline and at 8 weeks of treatment ]
    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]



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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:

  • 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.

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): NCT02702518


Locations
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United States, Illinois
Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Illinois Eye and Ear Infirmary
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Genentech, Inc.
National Eye Institute (NEI)
Investigators
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Principal Investigator: Sandeep Jain, MD University of Illinois at Chicago
  Study Documents (Full-Text)

Documents provided by Sandeep Jain, MD, University of Illinois at Chicago:
Additional Information:
Publications of Results:
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Responsible Party: Sandeep Jain, MD, Associate Professor of Ophthalmology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02702518    
Other Study ID Numbers: 2014-0372
R01EY024966-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2016    Key Record Dates
Results First Posted: August 10, 2021
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sandeep Jain, MD, University of Illinois at Chicago:
rhDNase I, Pulmozyme, oGVHD, Dry Eye
Additional relevant MeSH terms:
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Dry Eye Syndromes
Graft vs Host Disease
Lacrimal Apparatus Diseases
Eye Diseases
Immune System Diseases