NCT07218796招募中3 期
A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,
SpyGlass Pharma, Inc.1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年10月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mean IOP Reduction from Baseline (mmHg)
研究概览
简要总结
This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
- •Planned removal of cataract
- •Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception
排除标准
- •Uncontrolled systemic disease
- •History of incisional/refractive corneal surgery
- •Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliative, or pigmentary glaucoma
- •History of incisional glaucoma surgery or intraocular injections
- •Other ocular diseases, pathology, or conditions
研究组 & 干预措施
Timolol Maleate Ophthalmic Solution 0.5%
Active Comparator
干预措施: Timolol Maleate Ophthalmic Solution, 0.5% (Drug)
Bimatoprost Implant System / IOL Combination
Experimental
干预措施: Bimatoprost Implant System (Drug)
Bimatoprost Implant System / IOL Combination
Experimental
干预措施: SpyGlass IOL (Device)
Timolol Maleate Ophthalmic Solution 0.5%
Active Comparator
干预措施: Commercial IOL (Device)
结局指标
主要结局
Mean IOP Reduction from Baseline (mmHg)
时间窗: Weeks 2 and 6, and Month 3
Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
BCDVA 20/40 or better
时间窗: Month 6
Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better
次要结局
- Mean IOP Reduction from Baseline (mmHg)(Month 6, 9 and 12)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic SolutionGlaucomaCataractOcular HypertensionNCT06120842SpyGlass Pharma, Inc.201
已完成
3 期
Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid MarginHypotrichosisNCT00907426Allergan368
已完成
不适用
Evaluation of the Safety and Effectiveness of the Bimatoprost Implant System / IOL Combination in Patients With Ocular Hypertension or Mild to Moderate Open-angle GlaucomaOcular HypertensionCataractOcular HypertensionNCT07154797SpyGlass Pharma, Inc.24
已完成
3 期
Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT01216943Allergan126
已完成
3 期
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash HypotrichosisEyelash HypotrichosisNCT01391273Allergan173