NCT01254370已完成2 期
A Phase 2, Randomized Study Evaluating the Safety and Efficacy of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® in Subjects With Glaucoma or Ocular Hypertension and Ocular Surface Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen SAS
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Efficacy of Catioprost versus Travatan Z
研究概览
简要总结
The purpose of this study is to compare:
- the effect of Catioprost® and Travatan Z® on the ocular surface disease (OSD) in subjects with glaucoma or ocular hypertension and ocular surface disease.
- the intraocular pressure (IOP) lowering effect and safety of Catioprost® and Travatan Z® in subjects with glaucoma or ocular hypertension and ocular surface disease.
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
- Single (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
- •Be at least 18 years of age at Visit 1 (IOP Screening), of either sex and any race or ethnicity.
- •Be willing and able to provide written informed consent prior to any study procedures being performed.
- •Be willing and able to follow all instructions and attend all study visits.
- •Have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or chronic angle closure glaucoma with a patent iridotomy requiring treatment with an ocular hypertensive therapy in the study eye.
- •Agree to submit to a pregnancy test at Visit 1 and at Visit 4, or not be of childbearing potential.
- •Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential. Acceptable methods of birth control include: spermicide with barrier, oral, transdermal, injectable, or implantable contraception, IUD, abstinence, and surgical sterilization of partner. Female subjects are not of childbearing potential if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or are post-menopausal by at least 12 months.
排除标准
- •Have known sensitivity or poor tolerance to latanoprost or travoprost or any other component of the study medications.
- •Have any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component), ocular hypertension or chronic angle closure glaucoma with patent iridotomy in either eye.
- •Have an IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 34 mmHg in either eye.
- •Be currently pregnant, nursing, or planning a pregnancy during the study period; or be a woman that has a positive pregnancy test.
- •Have a history of any significant ocular condition(s) in either eye that would contraindicate the use of latanoprost or travoprost, or that might affect the study conduct or the interpretation of the study results.
- •Have any abnormality preventing reliable Goldmann applanation tonometry of either eye.
- •Have been previously non-responsive to prostaglandin analog therapy for reduction of IOP.
- •Have prior (within 30 days of Visit 1) or anticipated concurrent use of an investigational drug or device during the study period.
- •Have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
研究组 & 干预措施
Catioprost
Experimental
干预措施: Latanoprost (Drug)
Travatan Z
Active Comparator
干预措施: Travatan Z (Drug)
结局指标
主要结局
Efficacy of Catioprost versus Travatan Z
时间窗: 3 months
Efficacy measures: * Change from baseline in Intraocular Pressure (IOP) * Change in Ocular Surface Disease (OSD)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
RMP-A03 Ocular Suspension in Patients With PterygiumPterygiumNCT05794204Suzhou Raymon Pharmaceuticals Company, Ltd.77
已完成
2 期
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic SolutionGlaucoma Open-angleNCT02754596Glaukos Corporation154
已完成
4 期
Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT00061503Alcon Research
已完成
2 期
A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle GlaucomaOpen Angle GlaucomaOcular HypertensionNCT01229982Mati Therapeutics Inc.121
已完成
不适用
Primary Angle Closure Glaucoma and Aqueous DynamicsPrimary Angle ClosureNCT00719290Guy's and St Thomas' NHS Foundation Trust24