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DNase Treatment for Dry Eyes

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02193490
Recruitment Status : Terminated (Sponsor ceased sponsorship and terminated the research citing slow accrual of subjects in this clinical trial.)
First Posted : July 17, 2014
Results First Posted : November 5, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Research to Prevent Blindness
Genentech, Inc.
Information provided by (Responsible Party):
Sandeep Jain, MD, University of Illinois at Chicago

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Drug: DNase Drug: Vehicle Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
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
Study Start Date : July 2014
Actual Primary Completion Date : October 11, 2017
Actual Study Completion Date : October 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

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 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




Primary Outcome Measures :
  1. 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.

  2. 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]


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
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United States, Illinois
Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Research to Prevent Blindness
Genentech, Inc.
Investigators
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Principal Investigator: Sandeep Jain, MD University of Illinois at Chicago
  Study Documents (Full-Text)

Documents provided by Sandeep Jain, MD, University of Illinois at Chicago:
Additional Information:
Publications:
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Responsible Party: Sandeep Jain, MD, Associate Professor of Ophthalmology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02193490    
Other Study ID Numbers: 2012-1106
First Posted: July 17, 2014    Key Record Dates
Results First Posted: November 5, 2019
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Sandeep Jain, MD, University of Illinois at Chicago:
DNase, Pulmozyme, dry eye disease, treatment
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases