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临床试验/NCT04461249
NCT04461249已完成不适用

Comparison Between the Effect of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To Compare Between the Efficacy of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma

研究概览

简要总结

Elevated IOP is a key risk factor for the progression of glaucoma. IOP is subjected to diurnal fluctuation in healthy individuals and higher fluctuation in POAG . So, once-daily antiglaucoma drugs must have consistent efficacy throughout the day. Prostaglandin analogues (PGAs) have become the first-line drops for medical treatment of glaucoma worldwide. In our study, we compare between the efficacy and tolerability of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on diurnal IOP fluctuation in patients having POAG, IOP fluctuation was assessed before treatment , then 2 weeks and 6 weeks after. A comparable and significant reduction in IOP fluctuation occurred in the 3 groups. Side effects were mild and tolerable.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders aged 18 years or more.
  • Newly diagnosed POAG cases having :
  • IOP more than 21 mmHg Open angle on gonioscopy Showing both structural and functional damage (confirmed with OCT and visual field)

排除标准

  • Angle closure glaucoma.
  • Secondary glaucomas.
  • Advanced glaucoma likely to be uncontrolled on monotherapy or needing a low target IOP.
  • History of ocular trauma, laser or intraocular surgery.
  • Any other ocular disorder including uveitis and cystoid macular edema.
  • Known history of allergy or sensitivity to any components of the study medications.

研究组 & 干预措施

Latanoprost group

Latanoprost 0.005 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.

干预措施: Latanoprost 0.005% Ophthalmic Solution (Drug)

Travoprost group

Travoprost 0.004 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.

干预措施: Travoprost 0.004% ophthalmic solution (Drug)

Tafluprost group

Tafluprost 0.0015 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.

干预措施: Tafluprost Ophthalmic 0.0015% Ophthalmic Solution (Drug)

结局指标

主要结局

To Compare Between the Efficacy of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma

时间窗: 3 months from starting the treatment

Newly diagnosed primary open-angle glaucoma patients received one of the 3 study medications and intraocular pressure fluctuation measured in mmHg by using Goldmann applanation tonometer was compared to the baseline intraocular pressure and to vompare its efficacy to the other 2 drugs

次要结局

  • To Compare Between the 3 drugs regarding their tolerability and assess their side effects.(3 Months from starting the treatment)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Essam Faseeh

Resident of Ophthalmology

Kasr El Aini Hospital

研究点 (1)

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