Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to evaluate and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension.
This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one eye and the generic version in the other one. In the second period, drops are switched from one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0 (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of second period). Variations of intraocular pressure in each eye will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •>18 years old
- •Primary open angle glaucoma, glaucoma suspect or ocular hypertension
- •Without any treatment or treated with latanoprost or another prostaglandin analog
- •Intraocular pressure >21mmHg (without treatment or after a washout period)
排除标准
- •Intraocular pressure >30mmHg
- •Secondary glaucoma (uveitic, neovascular, traumatic ) or congenital glaucoma
- •Pseudoexfoliation syndrome
- •Pigmentary dispersion syndrome or Pigmentary glaucoma
- •Severe glaucoma; Cup-to-disc ratio ≥9/10 OU Loss of central visual field (central 10°)
- •Use of other topical medication to lower intraocular pressure
- •Pregnancy and breast-feeding
- •Being allergic to latanoprost or benzalkonium chloride (BAK)
- •Current use of acetazolamide (Diamox)
- •Changes of systemic doses of beta-blockers during study
- •Recent use of topical corticosteroids (<1 month)
- •Contact lens wearer
- •Closed angle at gonioscopy or past angle closure glaucoma
- •Filtration surgery (example. : trabeculectomy)
- •Selective Laser Trabeculoplasty (SLT) or Argon Laser Trabeculoplasty(ALT)
- •Recent Intraocular surgery (<3 months)
- •Refractive surgery
- •Recent iridotomy or capsulotomy (<3 months)
- •Past medical history of ocular trauma (example : angle recession)
- •Past or active uveitis
- •Herpetic keratitis
- •Monocular vision
研究组 & 干预措施
Generic latanoprost
1 eye drop hs
干预措施: Generic latanoprost (Drug)
Generic latanoprost
1 eye drop hs
干预措施: Brand-name latanoprost (Drug)
Brand-name latanoprost
1 eye drop hs
干预措施: Generic latanoprost (Drug)
Brand-name latanoprost
1 eye drop hs
干预措施: Brand-name latanoprost (Drug)
结局指标
主要结局
Change in Intraocular Pressure (IOP)
时间窗: 8 weeks, 16 weeks
Goldman applanation tonometry will be used to measure IOP.
次要结局
- Change in corneal staining(8 weeks, 16 weeks)
- Change in Conjunctival hyperemia(8 weeks, 16 weeks)
- Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)(8 weeks, 16 weeks)
研究者
Marie-Josée Fredette
MD, FRCSC
CHU de Quebec-Universite Laval