DNase Treatment for Dry Eyes

January 15, 2020 updated by: Sandeep Jain, MD, University of Illinois at Chicago

Safety and Efficacy Of Recombinant Human Deoxyribonuclease Eye Drops In Patients With Sjogren's and Non-Sjogren Dry Eye Disease

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: DNase
DNase 0.1% eye drops four times a day for 8 weeks
Drug: DNase
DNase 0.1% eye drops four times a day for 8 weeks
Other Names:
  • Pulmozyme
PLACEBO_COMPARATOR: Vehicle
Drug vehicle eye drops four times a day for 8 weeks
Drug: Vehicle
Drug vehicle eye drops four times a day for 8 weeks
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining
Time Frame: Between baseline and at 8 weeks of treatment
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.
Between baseline and at 8 weeks of treatment
The Change in the Ocular Surface Disease Index Score
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]
Between baseline and at 8 weeks of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Mucoid Debris Strands Between Baseline and 8-weeks
Time Frame: Between baseline and 8-weeks of treatment
The presence of mucoid debris/strands over the ocular surface was assessed and the amount graded as the absence of mucoid debris (0) or presence of mucoid debris (1+, 2+ or 3+) with a bigger number indicating greater presence of mucoid debris with "3+" implying presence of the highest amount of mucoid debris and indicating the worst outcome.
Between baseline and 8-weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Genentech, Inc.
Research to Prevent Blindness

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

October 11, 2017

Study Completion (ACTUAL)

October 11, 2017

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (ESTIMATE)

July 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-1106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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