NCT01223378已完成2 期
A Randomized, Multicenter, Single-Masked, Parallel-Group Dose Finding Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Open Angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 1
- 主要终点
- Change in Mean Diurnal IOP at Visit 6 (Day 28)
研究概览
简要总结
The objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Subjects must have a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OH) in one or both eyes.
- •IOP requirements at Visit 3, A mean/median IOP ≥ 26 mmHg at a minimum of 1 time point, ≥ 24 mmHg at a minimum of 1 time point, and ≥ 22 mmHg at 1 time point in the same eye, and Mean/median IOP ≤ 32 mmHg in both eyes at all 3 measurement time points.
- •Subjects with best-corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent ~20/100) or better in either eye.
排除标准
- •Subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
- •Subjects with known contraindications to nitric oxide (NO) treatment.
- •Subjects whose central corneal thickness was greater than 600um in either eye.
- •Subjects with any condition that prevented reliable applanation tonometry in either eye.
- •Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
- •Subjects with previous or active corneal disease.
- •Subjects with a history of severe dry eye.
- •Subjects with monophthalmia.
- •Subjects with optic disc hemorrhage.
- •Subjects with a history of central retinal vein and artery occlusion.
- •Subjects with a history of macular edema.
- •Subjects with any intraocular infection, inflammation, or laser surgery within the previous 6 months from Visit 1 (Screening).
- •Subjects who had incisional ocular surgery or severe trauma within the previous 6 months from Visit 1 (Screening).
- •Subjects with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and subjects with angle closure, congenital and secondary glaucoma, and subjects with history of angle closure in either eye.
- •Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
- •Subjects who were expected to require treatment with ocular or systemic corticosteroids.
- •Subjects who were in need of any other topical or systemic treatment of OAG or OHT.
- •Subjects with an anticipated need to initiate or modify medication (systemic or topical) that was known to affect IOP during the study period.
研究组 & 干预措施
BOL-303259-X
Experimental
ophthalmic solution
干预措施: BOL-303259-X (Drug)
Latanoprost
Active Comparator
ophthalmic solution
干预措施: Latanoprost (Drug)
结局指标
主要结局
Change in Mean Diurnal IOP at Visit 6 (Day 28)
时间窗: Baseline and Visit 6 (Day 28)
Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost
次要结局
- Change in Mean Diurnal IOP at Visits 4,5, and 7(Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29))
- IOP </=18mm Hg(Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29))
- Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)(baseline and Visit 6 (Day 28))
- Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)(baseline and Visits 4, 5 and 7 (Days 7, 14, and 29))
研究者
研究点 (1)
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