NCT06120842进行中（未招募）1 期
A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System 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 201 人开始时间: 2023年10月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 201
- 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 and compare two doses of 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
- Quadruple (Participant, Care Provider, Investigator, 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, pseudoexfoliation, or pigmentary glaucoma
- •History of incisional glaucoma surgery or intraocular injections
- •Other ocular diseases, pathology, or conditions
研究组 & 干预措施
Bimatoprost Implant System (High Dose) / IOL Combination
Experimental
干预措施: Bimatoprost Implant System (High Dose) (Drug)
Bimatoprost Implant System (High Dose) / IOL Combination
Experimental
干预措施: SpyGlass IOL (Device)
Bimatoprost Implant System (Low Dose) / IOL Combination
Experimental
干预措施: Bimatoprost Implant System (Low Dose) (Drug)
Bimatoprost Implant System (Low Dose) / IOL Combination
Experimental
干预措施: SpyGlass IOL (Device)
Timolol Maleate Ophthalmic Solution 0.5%
Active Comparator
干预措施: Timolol Maleate Ophthalmic Solution, 0.5% (Drug)
Timolol Maleate Ophthalmic Solution 0.5%
Active Comparator
干预措施: Commercially Available Aspheric Monofocal Non-Yellow Chromophore 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 reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints
次要结局
- Mean IOP Change from Baseline(Months 6, 12, 18, 24, 27, 30, 33, and 36)
- Proportion of eyes achieving BCDVA 20/40 or better(Months 3, 6, and 12)
- Mean IOP(Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36)
- Time to postoperative introduction of IOP-lowering medications(Total Study Period of 36 Months)
- Number of IOP-lowering medications introduced postoperatively(Total Study Period of 36 Months)
- Manifest refraction spherical equivalent(Month 3)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash HypotrichosisEyelash HypotrichosisNCT01391273Allergan173
已完成
3 期
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash HypotrichosisEyelash HypotrichosisNCT01391286Allergan36
已完成
不适用
Comparing Implant Stability Using Two Accepted Techniques for Implant SitesImplantNCT02096978Rutgers, The State University of New Jersey17
已完成
2 期
A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's DiseaseAlzheimer's DiseaseNCT02431468Neurotrope Bioscience, Inc.147
已完成
2 期
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic SolutionGlaucoma Open-angleNCT02754596Glaukos Corporation154
相关资讯
SpyGlass Pharma Completes Enrollment in Phase I/II Glaucoma Drug Delivery Study• SpyGlass Pharma has finished enrolling patients in its Phase I/II clinical trial evaluating its drug delivery platform for glaucoma and ocular hypertension.
• The platform delivers bimatoprost over three years and is implanted during routine cataract surgery, potentially expanding glaucoma treatment options.
• The company is preparing for an End of Phase II meeting with the FDA to discuss advancing the platform into Phase III pivotal studies.
• SpyGlass's technology aims to improve glaucoma care by integrating treatment into cataract procedures, enhancing adoption among surgeons.last yearSpyGlass Pharma Completes Enrollment in Phase I/II Glaucoma Drug Delivery Study• SpyGlass Pharma has finished enrolling patients in its Phase I/II clinical trial for a novel drug delivery platform targeting glaucoma and ocular hypertension.
• The platform delivers bimatoprost over three years, aiming to reduce intraocular pressure (IOP) via a sustained-release mechanism during cataract surgery.
• The company anticipates engaging with the FDA and moving towards Phase III trials, based on the outcomes of this study and prior first-in-human data.
• The SpyGlass platform could broaden glaucoma treatment during routine cataract procedures, potentially enhancing adoption among surgeons and practices.last yearSpyGlass Pharma Completes Phase I/II Trial Enrollment for Glaucoma Drug Delivery Platform• SpyGlass Pharma has finished enrolling patients in its Phase I/II clinical trial for a novel drug delivery platform designed to treat glaucoma and ocular hypertension.
• The platform delivers bimatoprost over three years during routine cataract surgery, aiming to reduce intraocular pressure (IOP) effectively.
• SpyGlass Pharma is preparing to meet with the FDA to discuss advancing its drug delivery platform to Phase III pivotal studies.
• The innovative platform could broaden glaucoma treatment during cataract procedures, potentially enhancing adoption among surgeons.last year