A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Comfort Immediately After Dosing
研究概览
简要总结
The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 of age or older.
- •Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
- •Best corrected visual acuity of 20/200 Snellen or better in each eye.
- •Intraocular pressure within protocol-specified range.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any abnormality preventing reliable applanation tonometry in the study eye(s).
- •Any eye conditions or procedures as specified in protocol.
- •Progressive retinal or optic nerve disease from any cause.
- •Use of contact lenses in the study eye(s).
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Travoprost
Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.
干预措施: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) (Drug)
Latanoprost
Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.
干预措施: Latanoprost ophthalmic solution 0.005% (XALATAN®) (Drug)
结局指标
主要结局
Comfort Immediately After Dosing
时间窗: 5 seconds
Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.
次要结局
未报告次要终点