NCT01510145已完成4 期
Multi-Center Study Comparing Efficacy and Tolerability of TRAVATAN® BAK-free (0.004% Travoprost) in Patients Previously on Latanoprost Ophthalmic Solution 0.005% Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 191
- 主要终点
- Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
研究概览
简要总结
The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye;
- •On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator;
- •Intraocular pressure (IOP) <30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy;
- •IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period;
- •Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study;
- •Able to follow instructions and willing and able to attend all study visits;
- •Best corrected Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each eye;
- •Must sign an informed consent form;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator;
- •Any abnormality preventing reliable applanation tonometry in either eye;
- •Corneal dystrophies in either eye;
- •Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye;
- •Any clinically significant, serious, or severe medical condition;
- •Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study;
- •Severe dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids;
- •Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit;
- •Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment;
- •Progressive retinal or optic nerve disease from any cause;
- •Women who are pregnant, lactating, or not using reliable means of birth control;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
TRAVATAN® BAK-free
Experimental
Travoprost 0.004% BAK-free, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
干预措施: Travoprost 0.004% BAK-free (Drug)
结局指标
主要结局
Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
时间窗: Baseline, Week 12
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
次要结局
- Percentage of Subjects Who Reach Target IOP (≤18 mmHg)(Week 12)
研究者
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