DNase Treatment for Dry Eyes

• Status: Terminated
• Trial end date: 2017-10-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborators: Genentech, Inc.; Research to Prevent Blindness
• Treatments: Ophthalmic Solutions; Tetrahydrozoline

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