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DNase Treatment for Dry Eyes

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

47 participants in 2 patient groups, including a placebo group

DNase
Active Comparator group
Description:
DNase 0.1% eye drops four times a day for 8 weeks
Treatment:
Drug: DNase
Vehicle
Placebo Comparator group
Description:
Drug vehicle eye drops four times a day for 8 weeks
Treatment:
Drug: Vehicle

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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