Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

Completed · Phase 1/Phase 2

Conditions studied: Dry Eye

In brief

The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.

Key facts

Study ID

NCT01118754

Run by

Santen Inc.

People needed

132

Starts

2010-04-01

Expected to finish

2010-12-01

Last updated by the study team

2011-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• confirmed diagnosis of dry eye defined by protocol
• 18 years or older, and sign written informed consent
• negative pregnancy test and utilizing reliable contraceptive throughout study

You may not qualify if…

• use of any topical ocular medications
• any ocular surgery within 90 days of study
• laser refractive surgery within one year of study
• ocular, lid disease/abnormalities that may interfere with the study
• corneal transplants
• uncontrolled systemic conditions
• females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
• participated in another drug trial within 30 days prior to study

Where it is running

• Study site — Inglewood, California, United States
• Study site — Torrance, California, United States
• Study site — Bloomfield, Connecticut, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New Albany, Indiana, United States
• Study site — Gretna, Louisiana, United States
• Study site — Bangor, Maine, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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