A Phase 2 Randomized, Multi-center, Parallel, Active-controlled Clinical Study to Evaluate the Safety and Efficacy of Intracameral PA5108 Ocular Implants in Patients With Primary Open-angle Glaucoma, or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Efficacy: change in mean diurnal intraocular pressure in study eye
研究概览
简要总结
The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.
详细描述
This is a randomised, parallel, masked, active-controlled study that will evaluate the efficacy and safety of a low dose and a high dose of PA5108 Ocular Implant with single redosing during the study, in adults with open-angle glaucoma or ocular hypertension.
The study will also collect information on the implant administration procedure and overall experience from study participants.
The study plans to recruit approximately 75 participants.
Eligible participants will be randomly selected to receive one of the following treatments:
- PA5108 Ocular Implant - low dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
- PA5108 Ocular Implant - high dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
- Latanoprost 0.005% eye drops in both eyes (control treatment group) If allocated to receive either of the ocular implants, a second implant of the same dose will be administered at 26 weeks and participants will be followed for safety and intraocular pressure control until week 58 or until the implant is no longer visible in the study eye.
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)
盲法说明
Due to the nature of the study design, the product and the treatment arms, neither the study Investigator nor participant can be completely masked as to the treatment being administered. The participant will be aware of randomization to either an ocular implant or eye drops but will remain masked as to the strength of implant administered.
The Investigator and implant administration personnel will be unmasked and be able to determine which strength of implant has been administered due to the size of the implant. Intraocular pressure assessments and certain safety assessments should be observer masked to the extent possible.
Study personnel/technicians performing some study assessments will be masked to the treatment randomization to the extent possible.
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
- •Ability to provide informed consent and follow study instructions
- •18 years of age or older
- •Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- •Qualifying IOPs across 2 visits following washout of IOP-lowering medication, if applicable
- •Qualifying best-corrected visual acuity BCVA using Early Treatment Diabetic Retinopathy Study (ETDRS) chart in study eye
- •Qualifying corneal endothelial cell density (CEDC) in the study eye
排除标准
- •Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.
- •Advanced or severe glaucoma
- •Disqualifying central corneal thickness in either eye
- •Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
- •Uncontrolled medical conditions
- •Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye
- •Have received intravitreal injections in the study eye within the last 3 months of the Screening Visit and anticipated need for an intravitreal injection during the course of the study
- •Unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days
研究组 & 干预措施
PA5108 Ocular Implant low dose
PA5108 Ocular Implant, low dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
干预措施: PA5108 Ocular Implant low dose (Combination Product)
PA5108 Ocular Implant high dose
PA5108 Ocular Implant, high dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
干预措施: Latanoprost 0.005% Ophthalmic Solution (Drug)
PA5108 Ocular Implant low dose
PA5108 Ocular Implant, low dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
干预措施: Latanoprost 0.005% Ophthalmic Solution (Drug)
PA5108 Ocular Implant high dose
PA5108 Ocular Implant, high dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
干预措施: PA5108 Ocular Implant, high dose (Combination Product)
Latanoprost ophthalmic solution 0.005%
Latanoprost ophthalmic solution 0.005% once daily pm in both eyes.
干预措施: Latanoprost 0.005% Ophthalmic Solution (Drug)
结局指标
主要结局
Efficacy: change in mean diurnal intraocular pressure in study eye
时间窗: From Baseline to 12 weeks
Incidence of ocular symptoms and ocular treatment-emergent adverse events.
时间窗: Day 1 to study completion until at least Week 58
Ocular safety and tolerability (AEs)
Clinically significant change on slit-lamp exam
时间窗: Day 1 to study completion until at least Week 58
Slit-lamp biomicroscopy of eye to observe clinically significant changes.
Clinically significant change in corneal endothelial cells
时间窗: Day 1 to study completion until at least Week 58
Corneal endothelial cell density (cells/mm2) measured by specular microscopy.
次要结局
- Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.(Weeks 2-52)