Conditions: Open Angle Glaucoma Ocular Hypertension
Keywords: Primary open angle glaucoma or ocular hypertension
Allocation:  | Intervention model: PARALLEL
Enrollment: 489

Brief 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.

Detailed description:

Arms:
arm 1: DE-111 ophthalmic solution arm 2: Tafluprost ophthalmic solution 0.0015% arm 3: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Interventions: intervention 1: DE-111 ophthalmic solution intervention 2: Tafluprost ophthalmic solution 0.0015% intervention 3: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: