Adherence of Patients Using Travalert® for Instillation of a Fixed Combination of Travoprost 0.004%/Timolol 0.5% Compared to a Concomitant Regimen of Travoprost 0.004% and Timolol 0.5%
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
The purpose of the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of open-angle glaucoma or ocular hypertension;
- •Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%;
- •Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy;
- •Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs;
- •Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit;
- •History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye;
- •History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue;
- •History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication;
- •Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye;
- •Any abnormality preventing reliable applanation tonometry of either eye;
- •Best-corrected visual acuity worse than 20/30 Snellen in either eye;
- •Use of any additional topical or systemic ocular hyposensitive medication during the study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Travalert with travoprost/timolol fixed combination
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
干预措施: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav) (Drug)
Travalert with travoprost/timolol fixed combination
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
干预措施: Travalert Dosing Aid (Device)
Travalert with travoprost and timolol
One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
干预措施: Travoprost 0.004% eye drops (Drug)
Travalert with travoprost and timolol
One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
干预措施: Timolol 0.05% eye drops (Drug)
Travalert with travoprost and timolol
One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
干预措施: Travalert Dosing Aid (Device)
结局指标
主要结局
Adherence
时间窗: 6 months
Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.
次要结局
未报告次要终点