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CTRI Number  CTRI/2024/06/068916 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On: 15/06/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy of three medicines as a combination eye drop and as three individual eye drops in patients with eye pressure (Glaucoma). 
Scientific Title of Study   Efficacy and compliance FDC Trisopt ophthalmic suspension versus individual eye drops in ocular hypertensive or glaucomatous patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Lional Raj D 
Designation  Medical Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Department Of Glaucoma, Dr. Agarwals Eye Hospital, 15, South Bypass Road Vannarpettai

Tirunelveli
TAMIL NADU
627003
India 
Phone  8754411261  
Fax    
Email  drlionalraj@dragarwal.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Lional Raj D 
Designation  Medical Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Department Of Glaucoma, Dr. Agarwals Eye Hospital, 15, South Bypass Road Vannarpettai


TAMIL NADU
627003
India 
Phone  8754411261  
Fax    
Email  drlionalraj@dragarwal.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Lional Raj D 
Designation  Medical Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Department Of Glaucoma, Dr. Agarwals Eye Hospital, 15, South Bypass Road Vannarpettai


TAMIL NADU
627003
India 
Phone  8754411261  
Fax    
Email  drlionalraj@dragarwal.com  
 
Source of Monetary or Material Support  
Dept. of Glaucoma, Dr. Agarwals Eye Hospital, 15, South Bypass Road Vannarpettai Tirunelveli 627003 TN India 
 
Primary Sponsor  
Name  Investigator initiated study 
Address  Dr. Agarwals Eye Hospital 15, South Bypass Road Vannarpettai, Tirunelveli 627003, Tamil Nadu, India  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Dr Lional Raj D  Dr. Agarwals Eye Hosptial  Dept. of Glaucoma, Dr. Agarwals Eye Hospital, 15, South Bypass Road Vannarpettai Tirunelveli 627003,India
Tirunelveli
TAMIL NADU 		 8754411261

drlionalraj@dragarwal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Agarwal’s Eye Hospital Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H402||Primary angle-closure glaucoma,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Three individual eye drops  Eye Drop 1: Brinzolamide 1%, Eye Drop 2: Brimonidine 0.2 % & Eye Drop 3: Timolol 0.5%. Treatment Duration: 3 Months 
Intervention  Trisopt ophthalmic suspension in Fixed Dose Combination  Single Vial fixed dose combination of Brinzolamide 1%, Brimonidine 0.2 % & Timolol 0.5%. Treatment Duration: 3 Months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Male or non-pregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.
2. Provide signed and dated informed consent in accordance with good clinical practice (GCP)
and local legislation prior to any study procedure.
3. Be able and willing to follow study instructions and complete all required visits.
4. Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
5. Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
6. Have a best spectacle-corrected visual acuity (BSCVA) equivalent to 20/200 or better in each
eye.
7. Adequate wash-out period prior to baseline of any ocular hypotensive medication. 
 
ExclusionCriteria 
Details  1. Subjects with angle closure glaucoma
2. Females who are pregnant, breast feeding, or planning a pregnancy.
3. Females of childbearing potential who do not agree to utilize an adequate form of contraception. 4. Current, or past history of, severe hepatic or renal impairment
5. Current, or history within 2 months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
6. Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
7. Functionally significant visual field loss  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in IOP from baseline (Day 1) to Week 12.  Change in IOP from baseline (Day 1) to Week 12. 
 
Secondary Outcome  
Outcome  TimePoints 
Drug Compliance by MARS-5  Week 6 and 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)   17/06/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response (Others) -  Manuscript
  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Manuscript

  6. For how long will this data be available start date provided 01-07-2024 and end date provided 30-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 To demonstrate the non-inferiority of Trisopt ophthalmic suspension (Single Vial fixed dose combination of Brinzolamide 1%, Brimonidine 0.2 % & Timolol 0.5%) compared with three individual eye drops of Brinzolamide 1%, Brimonidine 0.2 % & Timolol 0.5% in terms of efficacy and compliance.  
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