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

NCT01118754 Phase 1/Phase 2 COMPLETED

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.

Details

Lead sponsor	Santen Inc.
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	132
Start date	2010-04
Completion	2010-12

Conditions

• Dry Eye

Interventions

• DE-101 ophthalmic suspension
• DE-101 ophthalmic suspension
• DE-101 ophthalmic suspension vehicle

Primary outcomes

• Total fluorescein corneal staining — 8 weeks
• Ocular Symptom Severity — 8 weeks

Countries

United States