| CTRI Number |
CTRI/2024/05/068149 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the use and side effects of Netarsudil 0.02 percent eye drops in patients of glaucoma. |
|
Scientific Title of Study
|
TO STUDY THE EFFICACY AND SAFETY OF NETARSUDIL OPHTHALMIC SOLUTION 0.02 PERCENT IN PATIENTS OF POAG. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveena Rawat |
| Designation |
Primary DNB first year |
| Affiliation |
Northern Railway Central Hospital |
| Address |
Department of Ophthalmology Northern Railway Central Hospital Basant Lane New Delhi
New Delhi
DELHI
110055
India |
| Phone |
7976981837 |
| Fax |
|
| Email |
rawatdrpraveena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shailender Kumar Choudhary |
| Designation |
Assistant chief health director |
| Affiliation |
Norhtern Railway Central Hospital |
| Address |
Department of Ophthalmology Northern Railway Central Hospital Basant Lane New Delhi
New Delhi
DELHI
110055
India |
| Phone |
9717630563 |
| Fax |
|
| Email |
shailenderchoudhary@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shailender Kumar Choudhary |
| Designation |
Assistant chief health director |
| Affiliation |
Norhtern Railway Central Hospital |
| Address |
Department of Ophthalmology Northern Railway Central Hospital Basant Lane New Delhi
New Delhi
DELHI
110055
India |
| Phone |
9717630563 |
| Fax |
|
| Email |
shailenderchoudhary@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Northern Railway Central Hospital Basant lane Aram bag Paharganj New Delhi 110055 |
|
|
Primary Sponsor
|
| Name |
Northern Railway Central Hospital Basant Lane Aram Bag Paharganj New Delhi |
| Address |
Northern Railway Central Hospital Basant Lane Aram Bag Paharganj New Delhi 110055 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailender Kumar Choudhary |
Northern Railway Central Hospital |
Department of Ophthalmology, Ground Floor, OPD Room Number 4,Basant Lane,Aram Bag ,Paharganj,Delhi ,Pin code is 110055,India.
New Delhi
DELHI |
9717630563
shailenderchoudhary@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Northern Railway Central Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Netarsudil plus Timolol |
Netarsudil 0.02 percent administered topically to eye once daily in night for three month and Timolol 0.5 percent used in eye topically twice daily for three month. |
| Comparator Agent |
Timolol |
Timolol 0.05 percent eye drop used topically twice daily dosing for three month |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Already diagnosed case of POAG on one of the standard drug that will be Timolol 0.5 percent eye drop for more than 1month.
2. Age at least 45 years and above.
3 .IOP more than 17mmhg and less than 25 mmhg.
4. BCVA 6/9 or better by Snellens chart.
|
|
| ExclusionCriteria |
| Details |
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.
Advanced changes of glaucomatous optic nerve.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
3 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 |