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

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

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.

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