Phase 4 Study to Evaluate Efficacy And Safety of Three Different Preparations of Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- intraocular pressure (IOP) in mmHg
研究概览
简要总结
This study examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops preparations, commercially available in Italy, in subjects affected by primary open angle glaucoma.
详细描述
Prospective, randomized, single blinded study of the duration of 3 months, involving subjects affected by POAG or OH under therapy with different Latanoprost drugs (Galaxia, Iopize or Latanoprost Rathiopharm).
A total of 120 patients affected by POAG or OH newly diagnosed or already under topical therapy. will be recruited.
After a recruitment visit to assest eligibility of each subject, a "run-in" therapy composed of timolol 0,5% 2 drops per day will be prescribed for 4 weeks.
Then a baseline visit will be performed to evaluate IOP values and adverse effects in each subject. All subjects elegible for a therapy with a single dose of Latanoprost will be randomized into 3 arms.
After 4 weeks of therapy a second visit will be made to assest IOP changes and safety. Therapy will be continued for another 4 weeks, and after that, a final visit will be made.
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 (Investigator, Outcomes Assessor)
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
- •Age ranged between 18 and 80
- •Untreated IOP ranged between 21 and 30 mmHg
- •IOP already treated with a single drug (monotherapy) ranged between 10 and 28 mmHg
排除标准
- •History of adverse events or any controindication to drugs administred during sperimentation, i. e. Latanoprost and Timolol.
- •Narrow or closed iridocorneal angle.
- •History of acute angle-closure glaucoma.
- •Previous laser trabeculoplasty within 3 months before screening.
- •Severe visual field defects within 10° from fixation in at least one eye (at least 2 points with a p<0,5 in a pattern deviation map obtained from a reliable 24-2 Sita Standard SAP).
- •History of refractive surgery or any keratoplasty procedure, corneal opacities or diseases that make not suitable applanation tonometry.
- •Use of contact lenses.
- •BCVA less than 20/
- •Ocular inflammation/infection occurring within three months before screening.
- •History of bradicardia, systemic hypotension, bundle branch or any atrio-ventricular block
- •Women of childbearing potential who were not using adequate contraceptive methods or who were pregnant or nursing
研究组 & 干预措施
IOPIZE© eyedrops
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE©
干预措施: IOPIZE© Latanoprost eyedrops (Drug)
GALAXIA© eyedrops
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA©
干预措施: GALAXIA© Latanoprost eyedrops (Drug)
Latanoprost RATIOPHARM© eyedrops
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM©
干预措施: Latanoprost RATIOPHARM© latanoprost eyedrops (Drug)
结局指标
主要结局
intraocular pressure (IOP) in mmHg
时间窗: one month - two months
to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops
次要结局
- Tear Break-Up Time (BUT) expressed in seconds(one month - two months)
研究者
Luigi Varano, MD - Principal Investigator
M. D.
University of Catanzaro