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-
Overview
- Phase
- Phase 3
- Intervention
- DE-111 ophthalmic solution
- Conditions
- Open Angle Glaucoma
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Enrollment
- 489
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with primary open angle glaucoma or ocular hypertension
- •Provided signed, written informed consent
- •20 years of age and older
- •If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
Exclusion Criteria
- •Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- •Presence of any abnormality or significant illness that could be expected to interfere with the study.
Arms & Interventions
1
DE-111 ophthalmic solution
Intervention: DE-111 ophthalmic solution
2
Tafluprost ophthalmic solution 0.0015%
Intervention: Tafluprost ophthalmic solution 0.0015%
3
Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
Intervention: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
Outcomes
Primary Outcomes
Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study
Time Frame: 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.