NCT01239069

Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease

A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	DE-110 ophthalmic suspension high dose	ophthalmic suspension; high dose; QID
DRUG	DE-110 ophthalmic suspension low dose	ophthalmic suspension; low dose; QID
OTHER	Placebo	DE-110 ophthalmic suspension vehicle;QID

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-11-11
• Last updated: 2014-05-21

Locations

14 sites across 1 country: United States