An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 726
- 主要终点
- Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
研究概览
简要总结
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
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
- Double (Participant, Investigator)
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
- •18 years or older.
- •Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
- •Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
- •Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit
- •Willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study, including artificial tears.
- •Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
- •Use of contact lenses within 30 days of Visit
- •Use of contact lenses during the study.
- •Participation in an investigational drug or device study within 30 days of entering this study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Travoprost
One drop self-administered in the study eye(s) once daily for 90 days
干预措施: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) (Drug)
Latanoprost
One drop self-administered in the study eye(s) once daily for 90 days
干预措施: Latanoprost ophthalmic solution 0.005% (XALATAN®) (Drug)
结局指标
主要结局
Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
时间窗: Baseline, Day 90
The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point score) used to measure ocular symptoms, visual function and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.
次要结局
- Percentage of Patients With Corneal Fluorescein Staining Score = 0(Day 90)