Clinical trial NCT02193490: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Dry Eye
Keywords: DNase, Pulmozyme, dry eye disease, treatment
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Research to Prevent Blindness
name: Genentech, Inc.
First posted: 2014-07-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining
timeFrame: Between baseline and at 8 weeks of treatment
measure: The Change in the Ocular Surface Disease Index Score
timeFrame: Between baseline and at 8 weeks of treatment
Secondary outcomes:
Other outcomes:
measure: The Change in Mucoid Debris Strands Between Baseline and 8-weeks
timeFrame: Between baseline and 8-weeks of treatment
Locations:
city: Chicago
country: United States
facility: Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sandeep Jain, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.