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DNase Treatment for Dry Eyes

Primary Purpose

Dry Eye

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DNase
Vehicle
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring DNase, Pulmozyme, dry eye disease, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DNase

Vehicle

Arm Description

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

Drug vehicle eye drops four times a day for 8 weeks

Outcomes

Primary Outcome Measures

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.
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]

Secondary Outcome Measures

Full Information

First Posted
July 15, 2014
Last Updated
January 15, 2020
Sponsor
University of Illinois at Chicago
Collaborators
Research to Prevent Blindness, Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02193490
Brief Title
DNase Treatment for Dry Eyes
Official Title
Safety and Efficacy Of Recombinant Human Deoxyribonuclease Eye Drops In Patients With Sjogren's and Non-Sjogren Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor ceased sponsorship and terminated the research citing slow accrual of subjects in this clinical trial.
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 11, 2017 (Actual)
Study Completion Date
October 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Research to Prevent Blindness, Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
DNase, Pulmozyme, dry eye disease, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DNase
Arm Type
Active Comparator
Arm Description
DNase 0.1% eye drops four times a day for 8 weeks
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Drug vehicle eye drops four times a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
DNase
Other Intervention Name(s)
Pulmozyme
Intervention Description
DNase 0.1% eye drops four times a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo
Intervention Description
Drug vehicle eye drops four times a day for 8 weeks
Primary Outcome Measure Information:
Title
The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining
Description
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
Title
The Change in the Ocular Surface Disease Index Score
Description
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
Other Pre-specified Outcome Measures:
Title
The Change in Mucoid Debris Strands Between Baseline and 8-weeks
Description
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.
Time Frame
Between baseline and 8-weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Jain, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24255046
Citation
Tibrewal S, Sarkar J, Jassim SH, Gandhi S, Sonawane S, Chaudhary S, Byun YS, Ivanir Y, Hallak J, Horner JH, Newcomb M, Jain S. Tear fluid extracellular DNA: diagnostic and therapeutic implications in dry eye disease. Invest Ophthalmol Vis Sci. 2013 Dec 11;54(13):8051-61. doi: 10.1167/iovs.13-12844.
Results Reference
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PubMed Identifier
23169882
Citation
Sonawane S, Khanolkar V, Namavari A, Chaudhary S, Gandhi S, Tibrewal S, Jassim SH, Shaheen B, Hallak J, Horner JH, Newcomb M, Sarkar J, Jain S. Ocular surface extracellular DNA and nuclease activity imbalance: a new paradigm for inflammation in dry eye disease. Invest Ophthalmol Vis Sci. 2012 Dec 17;53(13):8253-63. doi: 10.1167/iovs.12-10430.
Results Reference
background
Links:
URL
https://chicago.medicine.uic.edu/directory/name/sandeep-jain-md-jain/
Description
Principal Investigator description

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DNase Treatment for Dry Eyes

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