DNase Treatment for Dry Eyes

Study Overview
=================
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.

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

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: DNase
* Drug: Vehicle


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DNase<br>DNase 0.1% eye drops four times a day for 8 weeks | Drug: DNase<br>* DNase 0.1% eye drops four times a day for 8 weeks<br>* Other names: Pulmozyme;|
| Placebo Comparator: Vehicle<br>Drug vehicle eye drops four times a day for 8 weeks | Drug: Vehicle<br>* Drug vehicle eye drops four times a day for 8 weeks<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNase, Pulmozyme, dry eye disease, treatment