NCT01707381已完成2 期
A Randomized, Single-Center, Open-Label, Crossover Study Comparing the Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% 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
- 25
- 试验地点
- 1
- 主要终点
- 24 Hour IOP
研究概览
简要总结
This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.
- •Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both eyes.
排除标准
- •Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening).
- •Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
- •Subjects with an irregular daily sleep schedule.
- •Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study.
- •Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP.
- •Subjects for whom concomitant use of medications may interact with the safety or efficacy of a nitric oxide.
- •Subjects with known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
- •Subjects who are expected to require treatment with ocular or systemic corticosteroids.
- •Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
- •Subjects who are unable to discontinue contact lens use during and for 24 hours before the laboratory study.
- •Subjects with a central corneal thickness greater than 600 μm in either eye.
- •Subjects with any condition that prevents reliable applanationtonometry 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 active optic disc hemorrhage.
- •Subjects with a history of central/branch retinal vein or artery occlusion.
- •Subjects with a history of macular edema.
- •Subjects with very narrow angles 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 with any intraocular infection or inflammation within 3 months prior to Visit 1 (Screening).
- •Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1 (Screening).
- •Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening).
研究组 & 干预措施
Timolol Maleate
Active Comparator
Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.
干预措施: Timolol maleate (Drug)
BOL-303259-X
Experimental
BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.
干预措施: BOL-303259-X (Drug)
结局指标
主要结局
24 Hour IOP
时间窗: after 4 weeks of treatment
Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment
次要结局
- 24-hour Ocular Perfusion Pressure(after 4 weeks of treatment)
- IOP Area Under the Curve Over 24 Hours(after 4 weeks of treatment)
研究者
研究点 (1)
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