NCT01240382

Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

Double-masked Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Multi-center Study, in Comparison to 0.1% Sodium Hyaluronate Ophthalmic Solution) - Phase III Confirmatory Study -

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: —

Summary

To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	3% DE-089 ophthalmic solution
DRUG	0.1% sodium hyaluronate ophthalmic solution

Timeline

• Primary completion: 2008-02-01
• First posted: 2010-11-15
• Last updated: 2014-08-13
• Results posted: 2014-08-08

Locations

1 site across 1 country: Japan