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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-04-08

Brief Summary

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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).

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Detailed Description

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Conditions

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Ocular Graft vs Host Disease Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rhDNase I

rhDNase I 0.1% eye drops 4 times a day for 8 weeks

Group Type ACTIVE_COMPARATOR

rhDNase I

Intervention Type DRUG

rhDNase I, 0.1% eye drops 4 times a day for 8 weeks

Vehicle

Drug vehicle eye drops 4 times a day for 8 weeks

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Drug vehicle 4 times a day for 8 weeks

Interventions

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rhDNase I

rhDNase I, 0.1% eye drops 4 times a day for 8 weeks

Intervention Type DRUG

Vehicle

Drug vehicle 4 times a day for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Pulmozyme Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No