An Open Label, Comparative, Sequential-dose, Multi-centre Study Involving Intracameral Administration of a PA5108 Latanoprost FA SR Ocular Implant Into the Eye of Patients With Mild-moderate Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 9
- 主要终点
- Safety and Tolerability-incidence of treatment emergent Adverse Events
研究概览
简要总结
This is a multi-centre, open label, interventional, comparative, phase I study to identify a safe and efficacious dose (within the range of 14.7mcg to 35.5 mcg) of PA5108 (PolyActiva product code) Latanoprost free acid (FA) sustained release (SR) Ocular Implant in adults who have Primary Open Angle Glaucoma.
详细描述
This is a multi-centre, open label, interventional, comparative, phase Ib dose ranging study to identify a safe and efficacious dose (within the range of 14.7 to 35.5 microgram) of PA5108 Latanoprost FA SR Ocular Implant in adults who have Primary Open Angle Glaucoma (POAG).
The proposed study is a single ascending dose design to determine the minimum effective dose that provides the target of >20% IOP lowering effect at 12 weeks with minimal adverse events.
Up to three single-dose cohorts will be assessed from the following implant strengths:
- 35.5 microgram
- 26.6 microgram
- 14.7 microgram
In addition, a repeat-dose cohort will be assessed from the following implant strength:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants who:
- •Diagnosis of primary open angle glaucoma.
- •Unmedicated 8:00am IOP ≥ 24 mmHg and ≤ 36mmHg in the intent to treat eye. Additionally, the IOP at 12:00 and 16:00 hrs must be ≥ 20mmHg and ≤ 36mmHg.
- •Corrected visual acuity in each eye greater than or equal to +0.3logMAR.
- •Minimum central endothelial cell density of greater than or equal to 1600 cells per mm2
- •Currently managing their POAG with IOP lowering drop therapy.
排除标准
- •Participants who:
- •Have pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
- •Have a history of or current ocular inflammation.
- •Have aphakic eyes or only one eye.
- •Recent surgery in the study eye surgery (including laser).
- •Clinically significant ocular disease in either eye (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca or infection) which might interfere with the study.
- •Known sensitivity to any component of the product (e.g. latanoprost or polytriazole sensitivity), or to topical therapy used during course of study (e.g. povidone iodine, or anaesthetics).
- •Ocular medication in either eye of any kind within 30 days of screening.
- •Central corneal thickness in either eye that is less than 470 µm or greater than 630 µm at screening (or a difference between the eyes >70 µm).
- •Any abnormality in either eye preventing reliable applanation tonometry, including aphakic eyes or significant corneal guttatae.
- •Any other clinically significant disease (as determined by physician) which might interfere with the study.
研究组 & 干预措施
14.7 mcg (single dose)
PA5108 Latanoprost FA SR Ocular Implant which releases 14.7 mcg.
干预措施: PA5108 Latanoprost FA SR Ocular Implant (Drug)
26.6 mcg (single dose)
PA5108 Latanoprost FA SR Ocular Implant which releases 26.6 mcg.
干预措施: PA5108 Latanoprost FA SR Ocular Implant (Drug)
35.5 mcg (single dose)
PA5108 Latanoprost FA SR Ocular Implant which releases 35.5 mcg.
干预措施: PA5108 Latanoprost FA SR Ocular Implant (Drug)
14.7 mcg (repeat dose)
Repeat dose of PA5108 Latanoprost FA SR Ocular Implant which releases 14.7 mcg.
干预措施: PA5108 Latanoprost FA SR Ocular Implant (Drug)
结局指标
主要结局
Safety and Tolerability-incidence of treatment emergent Adverse Events
时间窗: Incidence of Treatment-Emergent Adverse Events throughout the study (up to 1 year).
Assess the safety and tolerability of PA5108 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (Primary). Incidence of Treatment-Emergent Adverse Events from visit 1 until end of study. Safety laboratory evaluations (biochemistry, haematology, urinalysis). Physical examinations and vital signs. Changes in ocular examinations from baseline to end of study.
Effective dose
时间窗: Intraocular Pressure (IOP) change measured at; baseline, week 12 and week 26.
Determine the minimum effective dose (as daily release rate of LtpFA) that achieves an IOP lowering effect \>20% with minimal adverse events.
次要结局
- Ease of Use(At visit 2-Day 0, after use of device to insert the implant into the eye.)