| CTRI Number |
CTRI/2025/07/089922 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Real-World Study on the Effects of a Fixed-Dose Combination Eye Drop (Timolol 0.5 Percentage, Brimonidine 0.2 Percentage, and Brinzolamide 1 Percentage) in Patients with Glaucoma or Ocular Hypertension |
|
Scientific Title of Study
|
An Open-label, Observational, Non-comparative, Real world Study with Fixed dose combination (FDC) of Timolol 0.5%, Brimonidine 0.2% and Brinzolamide 1% eye drops (Trisopt) in patients with glaucoma or ocular hypertension |
| Trial Acronym |
TRISIGHT Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alokesh Ganguly |
| Designation |
Principal Investigator |
| Affiliation |
Priyamvada Birla Aravind Eye Hospital |
| Address |
10, Sir UN Brahmachari Sarani, Elgin, Kolkata, West Bengal 700017.
Priyamvada Birla Aravind Eye Hospital
Deoartment of opthalmology
C/O Priyamvada Birla Aravind Eye Hospital, 10, Near Belle Vue Clinic, Minto Park, Loudon Street, Circus Avenue-700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
7829577296 |
| Fax |
|
| Email |
animan198@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alokesh Ganguly |
| Designation |
Principal Investigator |
| Affiliation |
Priyamvada Birla Aravind Eye Hospital |
| Address |
10, Sir UN Brahmachari Sarani, Elgin, Kolkata, West Bengal 700017.
Priyamvada Birla Aravind Eye Hospital
Deoartment of opthalmology
C/O Priyamvada Birla Aravind Eye Hospital, 10, Near Belle Vue Clinic, Minto Park, Loudon Street, Circus Avenue-700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
7829577296 |
| Fax |
|
| Email |
alokeshganguly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alokesh Ganguly |
| Designation |
Principal Investigator |
| Affiliation |
Priyamvada Birla Aravind Eye Hospital |
| Address |
10, Sir UN Brahmachari Sarani, Elgin, Kolkata, West Bengal 700017.
Priyamvada Birla Aravind Eye Hospital
Deoartment of opthalmology
C/O Priyamvada Birla Aravind Eye Hospital, 10, Near Belle Vue Clinic, Minto Park, Loudon Street, Circus Avenue-700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
7829577296 |
| Fax |
|
| Email |
alokeshganguly@gmail.com |
|
|
Source of Monetary or Material Support
|
| Priyamvada Birla Aravind Eye Hospital
Deoartment of opthalmology
C/O Priyamvada Birla Aravind Eye Hospital, 10, Near Belle Vue Clinic, Minto Park, Loudon Street, Circus Avenue-700017 |
|
|
Primary Sponsor
|
| Name |
Dr Alokesh Ganguly |
| Address |
10, Sir UN Brahmachari Sarani, Elgin, Kolkata, West Bengal 700017 |
| Type of Sponsor |
Other [self] |
|
|
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 Alokesh Ganguly |
Priyamvada birla aravind eye hospital |
10, Sir UN Brahmachari Sarani, Elgin, Kolkata, West Bengal 700017, department of Glaucoma,Division: Opthalmology,
Room No.203A
Kolkata
WEST BENGAL |
9903428490
alokeshganguly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HP Poddar Memorial Clinic and Nursing Home INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H408||Other glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed dose combination (FDC) of Timolol 0.5%, Brimonidine 0.2% and Brinzolamide 1% eye drops (Trisopt) |
Dose: One drop of the FDC (Fixed Dose Combination) of Timolol 0.5%, Brimonidine 0.2%, and Brinzolamide 1% eye drops (Trisopt)
Frequency: Twice daily
Route of Administration: Ophthalmic (in the affected eye(s)
Total Duration of Intervention: 12 weeks (84 ± 2 days) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged 18 years with glaucoma or ocular hypertensives (one eye/both
eyes) confirmed by Goldmann applanation tonometry.
2. Subject with known cases of glaucoma requires early intensification (Physician discretion for
assessment)
3. Gonioscopy angle of 20 degree in the study eye
4. Subjects willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Subjects with known hypersensitivity to any of the components of the formulation.
2. Subjects who are completely blind
3. Subjects who are scheduled to undergo eye surgery during the study period.
4. Pregnancy and lactation:
Pregnant or lactating or planning to become pregnant during the study period.
Females who are not ready to use acceptable contraceptive methods during the course of study.
5. Trial related conditions:
Suspected inability or unwillingness to comply with the study procedures.
6. Any other conditions which would make the patient, in the opinion of the Investigator,
unsuitable for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This outcome will establish the IOP-lowering potential of the fixed-dose combination (FDC). |
Week 2, Week 8,Week 12.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes
Safety & tolerability of the FDC eye drops will be evaluated based on:
Incidence of treatment-emergent adverse events (TEAEs)
Changes in ophthalmologic parameters, such as:
Visual Acuity (VA)
Slit-lamp biomicroscopy findings |
Week 2, Week 8,Week 12. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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 clinical study is an open-label, observational, non-comparative, real-world investigation designed to evaluate the efficacy and safety of a fixed dose combination (FDC) of Timolol 0.5%, Brimonidine 0.2%, and Brinzolamide 1% eye drops (Trisopt) in patients with glaucoma or ocular hypertension. Conducted over a 12-week period, the study aims to assess the reduction in intraocular pressure (IOP) as the primary endpoint, with secondary outcomes focused on safety and tolerability, including monitoring adverse events and changes in ophthalmological parameters. A total of 120 subjects are planned for enrollment to account for a potential 20% dropout, ensuring that at least 100 patients complete the study. Participants receive one drop of the FDC twice daily in the affected eye(s), and are followed up at baseline, optionally at Week 2, and mandatorily at Weeks 8 and 12. The study is investigator-initiated and complies with ethical guidelines including ICH-GCP, Schedule Y, and the Declaration of Helsinki, with approval from an independent ethics committee and proper informed consent procedures. Data will be analyzed using SPSS software with descriptive statistics to determine clinical outcomes. |