Prospective, Multi-Center, Open-Label, Non-Randomized, Multi-Arm Study to Evaluate the Safety, Efficacy, and Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Implanted With a Posterior Chamber Intraocular Lens (PC-IOL) and Diagnosed With Mild to Moderate Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
研究概览
简要总结
The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. The main question it aims to answer is:
Does the BIM-DRS lower the pressure inside the eye to treat glaucoma or ocular hypertension?
Researchers will compare two different doses of the BIM-DRS implanted either with a pre-existing commercially available monofocal intraocular lens (IOL) or concurrently with the SpyGlass IOL (IOL with silicone pads (no drug)).
Participants will:
- Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated.
- Complete a baseline visit to further evaluate eligibility in the study eye.
- Undergo surgery to implant the BIM-DRS (BIM-DRS and SpyGlass IOL for Cohorts 3 and 4). Only one eye of each participant will be treated.
- Complete post-operative follow-up visits for evaluation at Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36 (last study visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
To minimize bias, IOP will be measured by 2 observers - one observer will perform measurements (unmasked to treatment), while the second observer will record the measurements (masked to treatment)
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
- •Pseudophakic or 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, or pigmentary glaucoma
- •History of incisional glaucoma surgery
- •Other ocular diseases, pathology, or conditions
