DNase Treatment for Dry Eyes

University of Illinois

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Dry Eye

Treatments

Drug: DNase

Drug: Vehicle

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02193490

2012-1106

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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