Status:
TERMINATED
DNase Treatment for Dry Eyes
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Research to Prevent Blindness
Genentech, Inc.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2017
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02193490
Start Date
July 1 2014
End Date
October 11 2017
Last Update
January 18 2020
Active Locations (1)
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1
Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago
Chicago, Illinois, United States, 60612