Randomized,Active Comparator-Controlled,Three Months,Open Label Clinical Trial to Compare Efficacy and Safety of Refrigeration-Free Latanoprost (0.005%) and Latanoprost (0.005%) Stored at Refrigeration Temperature in Patients With OAG or OHT
试验速览
- 阶段
- 不适用
- 发起方
- Aurolab
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
The purpose of this study is to:
- To evaluate the efficacy of Refrigeration-Free Latanoprost compared to Latanoprost stored at refrigeration temperature with respect to the diurnal intraocular pressure (IOP) change from baseline after 3 months of therapy in patients with open-angle glaucoma (OAG) or ocular hypertension.
- To evaluate the safety and tolerability of Refrigeration-Free Latanoprost in patients with open-angle glaucoma (OAG) or ocular hypertension.
详细描述
Latanoprost refrigeration free formulation is developed to overcome difficulties on storing drugs at 2-8˚ C in consumer end and also to avoid risk during transition. This formulation has the best solubilizing agent cyclodextrin to increase the solubility and stability of latanoprost API. To find out the efficacy and safety due to this additional excipient in this formulation rather than the cold storage product the investigators have to perform clinical trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 18 and 80 years of age
- •Newly diagnosed Primary Open-Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation, or Ocular hypertension.
- •Patient has a mean (or median) IOP of 24 and 36 mmHg in at least one eye
- •Patient has a best corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20/80) or better in each eye.
- •Patient should have the access / ability to refrigerate study drug.
- •Residence with 60 kms of Madurai
排除标准
- •Patient has a mean (or median) IOP >36 mmHg in either eye at the Screening Visit.
- •Patient has a history of or current abnormal corneal sensation or any abnormality in either eye preventing reliable Goldmann applanation tonometry
- •Pupil in either eye that will not dilate sufficiently for adequate evaluation of the retina
- •Patient has a history of retinal detachment, proliferative diabetic retinopathy, or any retinal disease in either eye that may be progressive during the study
- •Patient who has significant ocular symptoms or signs such as photophobia, flashes or streaks of light, metamorphopsia, diplopia, or transient loss of vision in either eye.
- •Patient has had intraocular surgery (e.g., cataract extraction) in either eye within 4months prior to Screening visit.
- •Patient is aphakic or has, in the judgement of the investigator, risk for ocular inflammation
研究组 & 干预措施
Refrigeration free Latanoprost
Latanoprost refrigeration free formulation as per randomization schedule.
干预措施: refrigeration free latanoprost (Drug)
latanoprost 2-8˚ C
latanoprost stored at 2-8˚ C
干预措施: latanoprost eye drops (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: 3 months
to evalate the change in intraocular pressure from baseline to end of treatment
次要结局
未报告次要终点