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

NCT01468168 Phase 2 COMPLETED

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

Details

Lead sponsor	Santen Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	183
Start date	2011-10
Completion	2012-11

Conditions

• Dry Eye Disease

Interventions

• DE-101 Ophthalmic Suspension
• DE-101 Ophthalmic Suspension
• DE-101 Ophthalmic Suspension Vehicle

Primary outcomes

• Tear volume increase from baseline — baseline and 6 months

Countries

United States