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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Santen Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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