DNase Treatment for Dry Eyes

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-10-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DNase

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

Group Type ACTIVE_COMPARATOR

DNase

Intervention Type DRUG

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

Vehicle

Drug vehicle eye drops four times a day for 8 weeks

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Drug vehicle eye drops four times a day for 8 weeks

Interventions

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DNase

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

Intervention Type DRUG

Vehicle

Drug vehicle eye drops four times a day for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Pulmozyme Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No