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DNase Treatment for Dry Eyes

This study is currently recruiting participants.
Verified April 2017 by Sandeep Jain, University of Illinois at Chicago
Sponsor:
ClinicalTrials.gov Identifier:
NCT02193490
First Posted: July 17, 2014
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Research to Prevent Blindness
Genentech, Inc.
Information provided by (Responsible Party):
Sandeep Jain, University of Illinois at Chicago
  Purpose
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.

Condition Intervention Phase
Dry Eye Drug: DNase Drug: Vehicle Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Of Recombinant Human Deoxyribonuclease Eye Drops In Patients With Sjogren's and Non-Sjogren Dry Eye Disease

Resource links provided by NLM:


Further study details as provided by Sandeep Jain, University of Illinois at Chicago:

Primary Outcome Measures:
  • Reduction in ocular surface staining as measured by Rose Bengal dye staining [ Time Frame: Between baseline and at 8 weeks of treatment ]

Secondary Outcome Measures:
  • The change in the Ocular Surface Disease Index score [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in ocular surface redness score on slit-lamp examination [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in tear secretion as measured by Schirmer I test [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • The proportion of eyes achieving complete ocular surface staining clearance after treatment [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Visual acuity change [ Time Frame: Between baseline and at 8 weeks of treatment ]
  • Change in number of corneal filaments (on slit-lamp examination) [ Time Frame: Between baseline and at 8 weeks of treatment ]

Other Outcome Measures:
  • The change in the test substance tolerance using visual analogue scale [ Time Frame: Between Day 1 (post-dose) and at weeks 2, 4, 6 and 8 ]
  • The proportion of subjects who were able to successfully complete a full eight weeks of therapy with topical administration four times per day [ Time Frame: Between baseline and at week 8 ]

Estimated Enrollment: 72
Study Start Date: July 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT02193490


Contacts
Contact: Clinical Trial, Line 312-918-0900 mun2@uic.edu
Contact: Sandeep Jain, MD 312-996-8936 jains@uic.edu

Locations
United States, Illinois
Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Sandeep Jain, MD    312-355-5220    jains@uic.edu   
Principal Investigator: Sandeep Jain, MD         
Sponsors and Collaborators
University of Illinois at Chicago
Research to Prevent Blindness
Genentech, Inc.
Investigators
Principal Investigator: Sandeep Jain, MD University of Illinois at Chicago
  More Information

Publications:
Responsible Party: Sandeep Jain, Associate Professor of Ophthalmology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02193490     History of Changes
Other Study ID Numbers: UIC-CNBL-1001
First Submitted: July 15, 2014
First Posted: July 17, 2014
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Sandeep Jain, University of Illinois at Chicago:
DNase, Pulmozyme, dry eye disease, treatment

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents