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-

NCT01342081 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Santen Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	489
Start date	2011-05

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

• DE-111 ophthalmic solution
• Tafluprost ophthalmic solution 0.0015%
• Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Primary outcomes

• Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study — Week 0(Baseline) and Week 4(End of Study)
  Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.

Countries

Japan