| CTRI Number |
CTRI/2025/09/095461 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Two Add-on Eye drop combinations for reducing eye pressure in Glaucoma patients |
|
Scientific Title of Study
|
TO COMPARE THE THERAPEUTIC EFFICACY OF 0.004 PERCENT
TRA VOPROST IN COMBINATION WITH 0.02 PERCENT NETARSUDIL VS 0.004
PERCENT TRA VOPROST IN COMBINATION WITH 0.5 PERCENT TIMOLOL IN
PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod Sharma |
| Designation |
Professor |
| Affiliation |
IGMC Shimla |
| Address |
Room no 1108, Eye OPD, New OPD building, IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9805122115 |
| Fax |
|
| Email |
Drsharma.track@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Sharma |
| Designation |
Professor |
| Affiliation |
IGMC Shimla |
| Address |
Room no 1108, Eye OPD, New OPD building, IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9805122115 |
| Fax |
|
| Email |
Drsharma.track@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Sharma |
| Designation |
Professor |
| Affiliation |
IGMC Shimla |
| Address |
Room no 1108, Eye OPD, New OPD building, IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9805122115 |
| Fax |
|
| Email |
Drsharma.track@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College, Shimla |
|
|
Primary Sponsor
|
| Name |
Dept of ophthalmology IGMCShimla |
| Address |
Dept Of Ophthalmology, Indira Gandhi Medical College, Shimla, Himachal Pradesh pincode 171001 |
| Type of Sponsor |
Government medical college |
|
|
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 Ananya Shree |
IGMC Shimla |
Eye OPD, 11th floor, New OPD Building, IGMC Shimla
Shimla
HIMACHAL PRADESH |
8146573586
Ananya.koki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGMC Shimla |
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 |
Travoprost 0.004% + Netarsudil 0.02% ophthalmic solution |
Travoprost 0.004% ophthalmic solution in combination with Netarsudil 0.02% ophthalmic solution, administered as one drop topically in the affected eye(s) once daily at night, for a duration of 12 weeks. |
| Comparator Agent |
Travoprost 0.004% + Timolol 0.5% ophthalmic solution |
Travoprost 0.004% ophthalmic solution in combination with Timolol 0.5% ophthalmic solution, administered as one drop topically in the affected eye(s) once daily at night, for a duration of 12 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1Old and new Eligible candidates with bilateral open angle glaucoma diagnosed on GAT, gonioscopy, fundus examination and visual field defects. All the previous anti-glaucoma drugs will be stopped for 3-4 weeks. OCT will be performed on a baseline basis and after 6 months.
2 Age greater than or equal to 18 years
3 Unmedicated IOP greater than 20 mm Hg and less than 36 mm Hg in both eyes despite treatment with Travoprost monotherapy for at least 6 weeks
4On Travoprost as a first line therapy for POAG, but showing insufficient IOP control and visual field deterioration.
5BCV A of 20/200 or better in at least 1 eye.
6Able to comply with general study requireme |
|
| ExclusionCriteria |
| Details |
1History of narrow angles or iridocorneal angle closure.
2Congenital glaucoma
3Previous refractive surgery
4Any active ocular inflammation or infection.
5Clinically significant dry eye syndrome that could interfere with IOP measurement or treatmentadherence.
6Central corneal thickness greater than 620 microns
7Known hypersensitivity or contraindications to Netarsudil or latanoprost (or their excipients).
8Other ocular diseases that might interfere with the study
9Use of systemic or ocular medications which can alter IOP within the past 4 weeks.
10Pregnant or lactating women.
11Participation in another clinical trial involving investigational drugs or devices within the past 30
days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the reduction in mean IOP with the use of 0.004 percent Travoprost in combination with 0.02
percent Netarsudil v/s 0.004 percent Travoprost in combination with 0.5 percent timolol in patients with
primary open angle glaucoma. |
Baseline, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The safety profile of 0.004 percent Travoprost in combination with 0.02 percent Netarsudil v/s 0.004 percent
Travoprost in combination with 0.5 percent timolol in patients with primary open angle glaucoma. |
Baseline, 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 4 |
|
Date of First Enrollment (India)
|
12/10/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This single-blind randomized controlled trial aims to compare the intraocular pressure-lowering efficacy and safety of topical netarsudil and timolol in patients with primary open-angle glaucoma (POAG) who have inadequate response to travoprost monotherapy. Eligible patients will be randomized to receive either netarsudil or timolol in addition to travoprost, with follow-up assessments of intraocular pressure, ocular side effects, and patient tolerability over a defined study period. The study is designed to provide evidence on the optimal second-line therapy for POAG, ensuring patient safety and scientific validity. |