DE-111 Against Timolol Ophthalmic Solution 0.5%
DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP-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.
Open Angle Glaucoma
Drug: DE-111 ophthalmic solution
Drug: Timolol ophthalmic solution 0.5%
|Study Design:||Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -|
- Change From Baseline in Mean Diurnal IOP at End of Study [ Time Frame: Week 0(Baseline) and Week 4(End of Study) ] [ Designated as safety issue: Yes ]Mean diurnal IOP was calculated as an average of IOP at 9:30 (pre-dose), 11:30 and 17:30.
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Experimental: DE-111 ophthalmic solution||Drug: DE-111 ophthalmic solution|
|Active Comparator: Timolol ophthalmic solution 0.5%||Drug: Timolol ophthalmic solution 0.5%|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342094
|Santen study sites|