NCT00767494终止3 期
Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 17
- 主要终点
- Mean IOP
研究概览
简要总结
The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs. AZOPT dosed BID 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 YOA or older
- •Either gender or any race
- •OAG or OHT
- •Currently on stable (at least 4 weeks) IOP lowering medication
- •IOP at screening visit ≥ 18mmHg in at least one eye
- •Mean IOP in same eye (at both eligibility 1&2 visits
- •24 and 36 mmHg at 9AM
- •21 and 36 mmHg at 11AM and 4PM
- •Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1
排除标准
- •Related to disease condition being investigated (OAG or OHT) in either eye
- •Severe central visual field loss
- •Angle shaffer grade < 2
- •C/D ratio >0.8(horizontal or vertical measurement)
- •Related to ocular patient history or current ocular condition in either eye
- •BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
- •Ocular infection or inflammation or laser surgery within the last 3 months
- •Intraocular surgery or trauma with the last 6 months
- •Any abnormality preventing reliable applanation tonometry
- •History or chronic, recurrently or current severe inflammatory disease
- •History of or current clinically significant or progressive retinal disease
- •History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study
- •Related to systemic or ocular medication in either eye
- •Allergy/hypersensitivity to study medications
- •Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period
- •Use of oral CAIs during the study
- •Recent use (<4 weeks prior to the study) of Aspirin (>1 gram)
- •Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP
- •Therapy with another investigational agent within 30 days prior to the Screening Visit
研究组 & 干预措施
1
Experimental
Travoprost/Brinzolamide AM, Vehicle PM
干预措施: Travoprost/Brinzolamide fixed combination (Drug)
2
Experimental
Travoprost/Brinzolamide PM, Vehicle AM
干预措施: Travoprost/Brinzolamide fixed combination (Drug)
3
Active Comparator
AZOPT AM and PM
干预措施: Azopt (Drug)
4
Active Comparator
TRAVATAN PM, Vehicle AM
干预措施: Travatan (Drug)
结局指标
主要结局
Mean IOP
时间窗: 9, 11, and 16:00 time points at Week 12
次要结局
- Mean diurnal IOP at Week 12(results pooled across 9,11, and 16:00 time points)
研究者
相似试验
已完成
2 期
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已完成
4 期
A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT00471380Alcon Research46
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Phase IV Randomised Double-masked Clinical Trial: Assessing Morning Versus Evening Dosing of a Fixed Dose Combination of Travoprost 0.004% / Timolol Maleate 0.5% in Patients With Primary Open-angle Glaucoma or Ocular HypertensionOpen-angle GlaucomaOcular HypertensionNCT00759239Alcon Research36
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4 期
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