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临床试验/NCT07641296
NCT07641296尚未招募1 期

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)

SpyGlass Pharma, Inc.0 个研究点目标入组 24 人开始时间: 2026年7月31日最近更新:
适应症

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

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

研究者

发起方
SpyGlass Pharma, Inc.
申办方类型
Industry
责任方
Sponsor

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