DNase Treatment for Dry Eyes

Dry Eye Clinical Trial

Official title:

Safety and Efficacy Of Recombinant Human Deoxyribonuclease Eye Drops In Patients With Sjogren's and Non-Sjogren Dry Eye Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02193490
• Other study ID #: 2012-1106
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 2014
• Est. completion date: October 11, 2017

Study information

• Verified date: January 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: October 11, 2017
• Est. primary completion date: October 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• DNase
DNase 0.1% eye drops four times a day for 8 weeks
• Vehicle
Drug vehicle eye drops four times a day for 8 weeks

Locations

Country	Name	City	State
United States	Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Genentech, Inc., Research to Prevent Blindness

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Change in Mucoid Debris Strands Between Baseline and 8-weeks	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.	Between baseline and 8-weeks of treatment
Primary	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.	Between baseline and at 8 weeks of treatment
Primary	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]	Between baseline and at 8 weeks of treatment

External Links

•   Principal Investigator description