DNase Treatment for Dry Eyes

NCT02193490 | Terminated Phase 1 Results

• 1 other identifier: 2012-1106
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

DNase, Pulmozyme, dry eye disease, treatment

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (1)

• The Change in Mucoid Debris Strands Between Baseline and 8-weeks

  Between baseline and 8-weeks of treatment

Study Arms (2)

DNase

ACTIVE COMPARATOR

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

Drug: DNase

Vehicle

PLACEBO COMPARATOR

Drug vehicle eye drops four times a day for 8 weeks

Drug: Vehicle

Interventions

DNase DRUG

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

Also known as: Pulmozyme

DNase

Vehicle DRUG

Drug vehicle eye drops four times a day for 8 weeks

Also known as: Placebo

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Research to Prevent Blindness: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

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

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• 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.

  PMID: 24255046 BACKGROUND

• 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.

  PMID: 23169882 BACKGROUND

Related Links

• Principal Investigator description

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Deoxyribonucleases; dornase alfa

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Limitations and Caveats

Outcomes of this clinical trial shouldn't be over-interpreted for benefit. Accurate assessment of therapeutic implications of DNase eye drops will only be possible after adequately powered definitive pivotal trials. Small sample size is a limitation.

Results Point of Contact

• Title: Dr. Sandeep Jain
• Organization: University of Illinois Chicago

jains@uic.edu

312-996-4476

Study Officials

• Sandeep Jain, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 17, 2014
• Study Start: July 1, 2014
• Primary Completion: October 11, 2017
• Study Completion: October 11, 2017
• Last Updated: January 18, 2020
• Results First Posted: November 5, 2019

Record last verified: 2020-01

Locations

US (1)