NCT03216096

Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease

A Prospective, Open Label, One-arm, 4-weeks Study Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease -Phase 1 Study in Dry Eye Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Placebo ophthalmic solution and 3% DE-089 ophthalmic solution	Placebo ophthalmic solution; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 2-week run-in period 3% DE-089 ophthalmic solution; ; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 4-week treatment period

Timeline

• Start date: 2017-09-08
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2017-07-13
• Last updated: 2018-08-31

Locations

2 sites across 1 country: Taiwan