Non-inferiority of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Patients With Open-angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Intraocular pressure (mm Hg)
研究概览
简要总结
The purpose of this study is to evaluate the effect of microdrops vs. standard eyedrops of 0.5% timolol maleate in adults with primary open-angle glaucoma or ocular hypertension in terms of intraocular pressure-lowering efficacy and cardiovascular side effects.
详细描述
This randomized, single-masked, parallel study aims to evaluate the safety and efficacy of microdrops of 0.5% timolol maleate administered with Nanodropper (experimental intervention) compared to standard drops of 0.5% timolol maleate (active comparator) in patients with primary open-angle glaucoma (OAG) or ocular hypertension (OHT) at Aravind Eye Hospital. At the beginning of the test day, baseline (pre-drug) intraocular pressure (IOP), resting heart rate (HR), and resting systolic and diastolic blood pressure (BP) measurements will be collected. Participants will be randomized to receive standard eyedrops or microdrops of 0.5% timolol maleate (one drop per eye), which will be administered by a trained technician at t = 0. IOP, HR, and BP measurements will be repeated by a masked investigator at t = 1, 2, 5, and 8 hours after drug administration.
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 (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 years old
- •Recent diagnosis of primary OAG or OHT
- •Treatment-naive (not currently using ophthalmic medication)
- •Baseline IOP between 21-35 mm Hg
- •Corrected Snellen visual acuity of 6/60 or better in each eye
排除标准
- •<18 years old
- •A recent history (within the past 6 months) of ocular trauma, infection, or uveitis
- •Baseline IOP <21 mm Hg or >35 mm Hg
- •History of cardiovascular, pulmonary, cerebrovascular, or chronic renal disease
- •History of borderline or uncontrolled systemic arterial hypertension
- •Use of any systemic α-agonist or β-blocker within 30 days of study commencement
- •History of receiving general anesthesia within the previous 30 days
- •Pregnant women and nursing mothers
结局指标
主要结局
Intraocular pressure (mm Hg)
时间窗: 8 hours after drug administration
次要结局
- Resting heart rate (bpm)(8 hours after drug administration)
- Resting systolic and diastolic blood pressure (mm Hg)(8 hours after drug administration)