| CTRI Number |
CTRI/2025/09/094026 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of efficacy and safety of Fixed Drug Combination of Timolol with two different molecules:Brinzolamide and Brimonidine |
|
Scientific Title of Study
|
Comparative study for efficacy and safety of fixed drug combination between Timolol Maleate(0.5 percent) plus Brinzolamide(1 percent) and Timolol Maleate (0.5 percent) plus Brimonidine Tartrate(0.2 percent) in Primary Open Angle Glaucoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushi Macwan |
| Designation |
1st year post graduate student |
| Affiliation |
GCS Medical College,Hospital and Research Centre |
| Address |
Room 210,F1 block GCS Residents hostel,GCS Medical College Hospital and Research Centre,opp.DRM office,Naroda road,near Chamunda bridge,Ahemdabad-Gujarat 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
8160863074 |
| Fax |
|
| Email |
khushimacwan1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ruchi Kabra |
| Designation |
Associate Professor,Department of Ophthlmology |
| Affiliation |
GCS Medical College,Hospital and Research Centre |
| Address |
Department of Ophthalmology,GCS Medical College Hospital and Research Centre,opp.DRM office,Naroda road,near Chamunda bridge,Ahemdabad-Gujarat 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9327456667 |
| Fax |
|
| Email |
drruchis@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Khushi Macwan |
| Designation |
1st year post graduate student |
| Affiliation |
GCS Medical College,Hospital and Research Centre |
| Address |
Room 210,F1 block GCS Residents hostel,GCS Medical College Hospital and Research Centre,opp.DRM office,Naroda road,near Chamunda bridge,Ahemdabad-Gujarat 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
8160863074 |
| Fax |
|
| Email |
khushimacwan1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GCS medical college hospital and research centre |
| Address |
GCS medical college ,Hospital and research centre,opp.DRM office, near Chamunda bridge, Naroda Road,Ahmedabad-380025, Gujarat |
| Type of Sponsor |
Private 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 |
| DrKhushi Macwan |
OPD NO. 42 TO 47,Department of Ophthalmology,GCS Hospital |
GCS Medical College,Hospital and Research Centre,opp. DRM office,Naroda road,near Chamunda bridge,Ahemdabad,Gujarat
Ahmadabad
GUJARAT |
8160863074
khushimacwan1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (BIOMEDICAL & HEALTH RESEARCH) GCS Medical College,Hospital and Research Centre |
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 |
| Comparator Agent |
Timolol Maleate plus Brimonidine Tartrate |
Timolol Maleate (0.5%) plus Brimonidine Tartrate (0.2%) eye drops twice daily for six months |
| Intervention |
Timolol Maleate plus Brinzolamide |
Timolol Maleate (0.5%) plus Brinzolamide (1%) eye drops twice daily for six months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Freshly diagnosed primary open angle glaucoma patients
2.Intraocular pressure more than or equal to 21mmHg
3.Patients already being treated with study drug
4.Age more than 20 years |
|
| ExclusionCriteria |
| Details |
1.Patients on or requiring systemic or topical anti-glaucoma medications other than these two Fixed Drug Combinations
2.Patients with Best Corrected Visual Acuity less than 6/60
3.Patients with Secondary open angle glaucoma
4.Cataract surgery within 3 months of study
5.Pre-existing macular and retinal pathologies,ocular surgery,ocular trauma
6.Known allery to Sulfa group
7.History of hypersensitivity to any of the study medication or their products
8.Contact lens users
9.Pregnant women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy:
-IOP reduction in mmHg
-Optic disc changes
-Visual field changes
-RNFL by OCT
Safety
-tolerability/adverse reactions
-Side effects |
Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare compliance of both Fixed Drug Combination |
baseline , 2nd week,1 month,3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2025 |
| 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="6"
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
|
Study design: Prospective comparative study Study duration: 1.5 years • Participants: Patients with POAG • Drugs Used: Timolol with Brinzolamide and Timolol with Brimonidine SAMPLE SIZE : 50 patients in each group (total 100 patients) -Group I: Patients of POAG treated with FDC of Timolol + Brinzolamide -Group II: Patients of POAG treated with FDC of Timolol + S Brimonidine • Outcome Measures: evaluation at baseline(0). Follow up at 2nd week, 1 month,3 months and 6 months for efficacy and safety Efficacy: IOP reduction in mmHg Optic disc changes Visual field changes RNFL Safety: Tolerability/adverse reactions Side effects Data analysis: -Paired t-test and unpaired t-test for IOP reduction comparison -Chi-square test for adverse events |