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临床试验/CTRI/2024/05/068149
CTRI/2024/05/068149尚未招募Phase 3 4

TO STUDY THE EFFICACY AND SAFETY OF NETARSUDIL OPHTHALMIC SOLUTION 0.02 PERCENT IN PATIENTS OF POAG.

Northern Railway Central Hospital Basant Lane Aram Bag Paharganj New Delhi1 个研究点 分布在 1 个国家入组 130 人开始时间: 2024年6月11日最近更新:
适应症
相关药物

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
130
试验地点
1
主要终点
To compare the IOP reduction between the combination therapy of netarsudil with timolol versus timolol monotherapy calculated by averaging the mean IOP over a period of 3 month.

研究概览

简要总结

The aim of the trial is to study the efficacy and side effects of netarsudil 0.02% eye drops in patients of primary open angle glaucoma over a periods of 3 month. The sample size would be 130 patients and the duration of the trial will be for 18 months .The type of study is randomized control trial . The eligible patients are diagnosed case of POAG who is already  taking timolol 0.5% twice daily of age 45 year and above and IOP would be between 17 and 25 mm hg with visual acuity of 6/9 or better. The patients having advanced glaucomatous changes and having any other ocular pathology which affects IOP or media clarity will be excluded from the study.

After initial examination  like visual acuity ,IOP measurement ,slit lamp examination ,gonioscopy ,fundus and  baseline investigation like OCT for RNFL analysis the randomization of patients will be done by computer allocation system in two arms . The one arm will be provide netarsudil 0.02%  once daily eye drop as a combination therapy with timolol 0.5% twice daily and the other arm will remain on monotherapy of timolol 0.5% .

The follow up visit will be at 2 week ,6 week ,3 month . The visual acuity ,IOP, slit  lamp examinations , schirmers test will be done at each visit . The fundus examination and OCT for RNFL analysis will be done at 3 month .

The primary outcome will be IOP reduction from baseline in percentage which is calculated by averaging  the mean of mean IOP measurements at 2 week ,6 week and 3 month at 9 am , 11 am and 1pm

研究设计

研究类型
干预性
分配方式
随机
盲法
开放(无盲法)

入排标准

年龄范围
45.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Already diagnosed case of POAG on one of the standard drug that will be Timolol 0.5 percent eye drop for more than 1month.
  • Age at least 45 years and above.
  • 3 .IOP more than 17mmhg and less than 25 mmhg.
  • BCVA 6/9 or better by Snellens chart.

排除标准

  • Any ocular disease likely to affect IOP.
  • Any pathology of eye affecting media clarity.
  • Any infective /inflammatory pathology of eye at screening time.
  • Any ocular trauma in last 6 month .
  • CCT OF patients more than 625 micron.
  • Hypertension.

结局指标

主要结局

To compare the IOP reduction between the combination therapy of netarsudil with timolol versus timolol monotherapy calculated by averaging the mean IOP over a period of 3 month.

时间窗: 3 month

次要结局

  • The ocular safety variables with netarsudil are ocular symptoms like dry eyes, ,corneal deposits, corneal verticillata ,conjunctival hemorrhage ,corneal staining ,headaches, blurry vision,instillation site pain, erythema.(3 month)

研究者

发起方
Northern Railway Central Hospital Basant Lane Aram Bag Paharganj New Delhi
申办方类型
Research institution and hospital
责任方
主要研究者
主要研究者

Praveena Rawat

Northern Railway Central Hospital

研究点 (1)

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标识符

CTRI 编号
CTRI/2024/05/068149

日期

最近更新
(2年前)

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