NCT02702518TerminatedPhase 1
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
University of Illinois at Chicago2 sites in 1 country58 target enrollmentStarted: April 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- The Change in the Corneal Surface Staining as Measured by Dye Staining Within Groups.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •11-15 <2 13-22 Mild/Moderate
- •6-10 2-3 23-32 Severe
- •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-
- •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.
Arms & Interventions
rhDNase I
Active Comparator
rhDNase I 0.1% eye drops 4 times a day for 8 weeks
Intervention: rhDNase I (Drug)
Vehicle
Placebo Comparator
Drug vehicle eye drops 4 times a day for 8 weeks
Intervention: Vehicle (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- The Change in Ocular Surface Disease Index (OSDI) Score Within Groups(Between baseline and at 8 weeks of treatment)
Investigators
Sandeep Jain, MD
Associate Professor of Ophthalmology
University of Illinois at Chicago
Study Sites (2)
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