A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension Compared to Placebo for the Treatment of Dry Eye Disease

Santen Inc.0 sites183 target enrollmentOctober 2011

Overview

To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

November 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Individuals considered for entry into the study will be of either sex and any race who have:
•a confirmed diagnosis of dry eye,
•are willing to use no ocular treatments during the study other than study medication,
•have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
•will not use contact lenses during the study,
•Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
•18 years of age or older,
•able to understand and provide written informed consent

•Subjects with any of the following are not eligible to participate in the study:
•Fluorescein corneal staining or conjunctival staining that is too severe
•Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
•Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
•Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
•Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
•Ocular(including lid)disease/abnormality that may interfere with the study
•Corneal transplant in either eye, at any time prior to enrollment in the study
•Laser refractive surgery less than one year prior to Visit 1 (Day 1)
•Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)