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-
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 489
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
DE-111 ophthalmic solution
干预措施: DE-111 ophthalmic solution (Drug)
2
Tafluprost ophthalmic solution 0.0015%
干预措施: Tafluprost ophthalmic solution 0.0015% (Drug)
3
Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
干预措施: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5% (Drug)
结局指标
主要结局
Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study
时间窗: 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.
次要结局
未报告次要终点