DNase Treatment for Dry Eyes

Phase 2TerminatedNCT02193490

University of Illinois at Chicago47 enrolled

Overview

The purpose of this study is to evaluate the tolerability and preliminary efficacy of DNase eye drops in patients with Sjogren's and Non-Sjogren Dry Eye Disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dry Eye

Interventions

DNaseDRUG

DNase 0.1% eye drops four times a day for 8 weeks

VehicleDRUG

Drug vehicle eye drops four times a day for 8 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 years or older. * Capable of giving informed consent and does provide informed consent. * Documented Dry Eye Disease for at least 6 months. * 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. Exclusion Criteria: * Allergic to Deoxyribonuclease eye drops or any similar products, or excipients of Deoxyribonuclease 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. * The use of topical cyclosporine or corticosteroids within 2 weeks of enrollment * Have active drug/alcohol dependence or abuse history

Locations (1)

Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining

Corneal staining score as measured by Rose Bengal (RB) dye staining using National Eye Institute (NEI) 1995 workshop grading scale. The dye was applied to each eye and a slit lamp was used to observe corneal staining. The 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, for a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with RB dye defined as a score of 0 indicating the best outcome.

Time frame: Between baseline and at 8 weeks of treatment

The Change in the Ocular Surface Disease Index Score

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=\[(sum of scores for questions answered)×100\]/\[(total questions answered)×4\]

Time frame: Between baseline and at 8 weeks of treatment

Data from ClinicalTrials.gov

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