NCT01342081

DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

A Double-masked Study of DE-111 Ophthalmic Solution Versus Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension -Phase 3, Confirmatory Study-

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: —

Summary

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	DE-111 ophthalmic solution
DRUG	Tafluprost ophthalmic solution 0.0015%
DRUG	Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-09-01
• First posted: 2011-04-26
• Last updated: 2015-06-15
• Results posted: 2015-05-14

Locations

1 site across 1 country: Japan