NCT01664039已完成4 期
Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma
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
- 104
- 主要终点
- Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6
研究概览
简要总结
The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.
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 (Outcomes Assessor)
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
- •Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
- •Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
- •IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- •Able to follow instructions and be 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 read, sign, and date an Ethics Committee-approved 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 components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
- •Any abnormality preventing reliable applanation tonometry in either eye.
- •Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- •Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
- •History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
- •Contact lens wear.
- •Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
- •Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
- •Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating.
- •Unwilling to risk the possibility of darkened iris or eyelash changes.
- •Participation in any other investigational study within 30 days prior to the Screening Visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
TRAVATAN
Experimental
Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months
干预措施: Travoprost 0.004% ophthalmic solution (Drug)
LUMIGAN
Active Comparator
Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months
干预措施: Bimatoprost 0.01% ophthalmic solution (Drug)
结局指标
主要结局
Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6
时间窗: Baseline (Day 0), Month 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). 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 analysis.
次要结局
- Percentage of Subjects Who Reached Target IOP at Each Visit(Week 6, Month 3, Month 6)
- Mean Change From Baseline in IOP at Week 6 and Month 3(Baseline (Day 0), Week 6, Month 3)
- Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit(Baseline (Day 0), Week 6, Month 3, Month 6)
- Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6(Baseline (Day 0), Month 3, Month 6)
- Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6(Baseline (Day 0), Month 3, Month 6)
- Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6(Baseline (Day 0), Month 3, Month 6)
- Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6(Baseline (Day 0), Month 3, Month 6)
研究者
相似试验
已完成
4 期
Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT00061503Alcon Research
终止
4 期
Effects of Anti-Glaucoma Medications on the Ocular SurfaceGlaucomaNCT01315574Massachusetts Eye and Ear Infirmary14
已完成
3 期
A Long-term Safety Study of Once-daily TravatanGlaucoma, Open-angleOcular HypertensionNCT00051168Alcon Research502
已完成
4 期
Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.GlaucomaOcular HypertensionNCT00143208Pfizer's Upjohn has merged with Mylan to form Viatris Inc.250
已完成
3 期
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma PatientsPediatric GlaucomaElevated IOP in Pediatric PatientsOcular Hypertension in Pediatric PatientsNCT01652664Alcon Research184