Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertensive Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Number of participants with serious adverse events
研究概览
简要总结
Aim: Evaluation of a single subconjunctival injection of liposomal EggPC formulation of latanoprost in treating glaucoma.
Hypothesis: The investigators have already evaluated carrier stability, drug partitioning, in vitro drug release, tolerance, and efficacy of latanoprost-incorporated EggPC liposomes upon subconjunctival administration in both rabbit and monkey eyes. Therefore, the investigators hypothesize that this would be safe and efficacious in humans as well.
Methodology: A pilot study to assess a liposome formulation containing latanoprost. The investigators will recruit 6 study subjects with eyes that have raised IOP, for subconjunctival injection of this liposome formulation. The recruited eye will be injected and monitored for inflammation, toxicity and pain as primary end-points. Monitoring of the eye will be for the first 24 hours post-injection, week 2, months 1, 2 and 3 thereafter.
Importance: If proven safe, this method of drug delivery could potentially be used for treatment of raised intraocular pressures in blinding conditions such as glaucoma.
详细描述
The number of recorded adverse events and intolerance to the subconjunctival injection procedure by the participants during the study period was used as a measure of safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glaucoma patients who have eyes with raised IOP (baseline IOP >21 mmHg) due to end-stage glaucoma with a poor visual prognosis.
- •Exclusion criteria:
- •Active or recent eye infection, endophthalmitis
- •Known hypersensitivity to latanoprost
- •Previous glaucoma filtration surgeries or trabeculectomy
- •Intraocular pressure less than 12mmHg.
- •Inability to give informed consent.
- •Inability to safely administer a subconjunctival injection
- •Uncontrolled systemic hypertension, CVA or TIA within the previous month.
- •Pregnancy -
排除标准
- 未提供
研究组 & 干预措施
Lipolat
Subconjunctival injection of Lipolat into the superior bulbar conjunctiva of all enrolled participants
干预措施: Subconjunctival injection of liposomal latanoprost (Drug)
结局指标
主要结局
Number of participants with serious adverse events
时间窗: 3 months
次要结局
- intraocular pressure(3 months)
研究者
A/Prof Tina Wong
Associate Professor
Singapore Eye Research Institute