NCT01468168

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	DE-101 Ophthalmic Suspension	Ophthalmic suspension; QID
DRUG	DE-101 Ophthalmic Suspension	Ophthalmic suspension; QID
DRUG	DE-101 Ophthalmic Suspension Vehicle	Ophthalmic suspension vehicle; QID

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-11-09
• Last updated: 2012-12-17

Locations

13 sites across 1 country: United States