| CTRI Number |
CTRI/2021/03/031676 [Registered on: 03/03/2021] Trial Registered Prospectively |
| Last Modified On: |
08/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to evaluate the efficacy, safety and tolerability of triple fixed dose combination of Timolol 0.5% Brimonidine 0.2% Brinzolamide 1% eye drops in patients with Open angle glaucoma or ocular hypertension not responding to dual drug therapy |
|
Scientific Title of Study
|
An Open Label, Multicentric, Phase III, Prospective study to evaluate the efficacy, safety and tolerability of triple fixed dose combination of Timolol 0.5% Brimonidine 0.2% Brinzolamide 1% eye drops in patients with Open angle glaucoma or ocular hypertension not responding to dual drug therapy |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula S |
| Designation |
Sr VP Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula S |
| Designation |
Sr VP Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kumar M |
| Designation |
DGM Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
krishna@microlabs.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Micro Labs Limited |
| Address |
31 Race Course Road Bangalore 560001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R Krishna Das |
Aravind Eye Hospital Post Graduate Institute of Ophthalmology, Madurai |
Glaucoma Dept, No:1, Anna Nagar Pincode 625020
Madurai
TAMIL NADU |
04524356100
krishnadas@aravind.org |
| Dr Ganesh V Raman |
Aravind Eye Hospital, Post Graduate Institute of Ophthalmology Coimbatore |
Glaucoma Dept, Avinashi Rd, Civil Aerodrome Post, Sitra, pincode 641014
Coimbatore
TAMIL NADU |
04224360400
ganeshvr75@gmail.com |
| Dr Dnyanoba Darade |
BJ Medical College and Sassoon General Hospitals |
Dept of Ophthalmology
Jai Prakash Narayan Road, Near Pune Railway Station, Pincode 411001
Pune
MAHARASHTRA |
02026120161
ddnyanoba@gmail.com |
| Dr Suneeta Dubey |
Dr. Shroff’s Charity Eye Hospital |
Glaucoma Dept 5027, Kedarnath Road, Daryaganj Pincode 110002
North
DELHI |
01143524444
dubeysuneeta@hotmail.com |
| Dr Hemaxi P Desai |
GCS Medical College, Hospital and Research Centre |
Dept of Ophthalmology GCS Medical college Opp. DRM office, Nr. Chamunda Bridge Naroda Road
Ahmadabad
GUJARAT |
9429229114
bspatani@gmail.com |
| Dr P Seshu Babu |
Government Medical College and Hospital RIMS Srikakulam |
Dept of Ophthalmology Government Medical College & Government General Hospital
Pincode 532 001
Srikakulam
ANDHRA PRADESH |
08942279033
drseshubabupggh@yahoo.com |
| Dr SK Bhasker |
King Georges Medical University |
Dept of Ophthalmology, Shah Mina Rd, Chowk, Pincode 226003
Lucknow
UTTAR PRADESH |
05222258880
skbhasker@yahoo.com |
| Dr Aparna Rao |
LV Prasad Eye Institute, Bhubaneshwar |
Glaucoma Dept, Mithu Tulsi Chanrai Campus,
Patia , Pincode 751024
Cuttack
ORISSA |
06742653001
aparna@lvpei.org |
| Dr Sirisha Senthil |
LV Prasad Eye Institute, Hyderabad |
Glaucoma Unit, Kallam Anji Reddy Campus,L.V Prasad Marg, Banjara Hills, Road No:2 Pincode 500034
Hyderabad
TELANGANA |
04068102020
sirishasenthil@lvpei.org |
| Dr Ram Gopal B |
Narayana Nethralaya |
Glaucoma Dept, 21/C, Chord Rd, Near Iskcon Temple, 1st R Block, Rajajinagar,
Bangalore
KARNATAKA |
9449512206
dr.ramgopal@gmail.com |
| Dr Sushma Tejwani |
Narayana Netralaya 2 Bangalore |
258 A, Bommasandra, Hosur Road, PIN 560 099
Bangalore
KARNATAKA |
9902287370
sushmatej@gmail.com |
| Dr Susan Philip |
Regional Institute of Ophthalmology, Govt ophthalmic hospital Thiruvanathapuram |
Palayam - Airport Rd, Jai Vihar, Kunnukuzhy, Pincode 695035
Thiruvananthapuram
KERALA |
04712304046
drsusangeorge@gmail.com |
| Dr Lakshmi Kanta Mondal |
Regional Institute of Ophthalmology, Kolkata |
Regional Institute of Ophthalmology
Medical College,
88, College Street,
Kolkata
WEST BENGAL |
9836126283
lakshmi.mondal62@gmail.com |
| Dr Ronnie Jacob George |
Sankara Nethralaya |
Glaucoma Division, No. 41 Old No, 18, College Rd, Nungambakkam, Pincode 600006
Chennai
TAMIL NADU |
04442271500
drrg@snmail.org |
| Dr Reji Koshy Thomas |
St. Johns Medical College and Hospital |
Dept of Ophthalmology Pincode 560034
Bangalore
KARNATAKA |
08049466029
rejiann@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Dr. Shroff Charity Eye Hospital Ethics Committee |
Approved |
| Institutional Ethics Committe Regional Institute of Ophthalmology, Thiruvanathapuram |
Approved |
| Institutional Ethics Committe, REGIONAL INSTITUTE OF OPHTHATMOLOGY, kolkata |
Approved |
| Institutional Ethics Committee Aravind Eye Hospital, Post Graduate Institute of Ophthalmology and PSG institute Coimbatore |
Approved |
| Institutional Ethics Committee Aravind Eye Hospital Post Graduate Institute of Ophthalmology, Madurai |
Approved |
| Institutional Ethics Committee BJ Medical College and Sassoon General Hospitals Pune |
Approved |
| Institutional Ethics Committee GCS medical college |
Approved |
| Institutional Ethics Committee Govt. Medical College Govt.General Hospital Srikakulam |
Approved |
| Institutional Ethics Committee King Georges Medical University |
Approved |
| Institutional Ethics Committee L V Prasad Eye Institute Bhubhaneshwar |
Approved |
| Institutional Ethics Committee St. Johns Medical College Hospital |
Approved |
| Institutional Review Board - Ethics Committee , Vision Research Foundation Sankara hospital |
Approved |
| L V Prasad Eye Institute Ethics Committee Hyderabad |
Approved |
| Narayana Nethralaya Ethics Committee, Bangalore |
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 |
NA |
NA |
| Intervention |
Triple fixed dose combination of Timolol 0.5%, Brimonidine 0.2%, Brinzolamide 1% eye drops one drop twice a day for 12 weeks |
Eye drops to be administered twice a day (at 8 AM and 8 PM), for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects ≥18 years of age of both gender
2. Diagnosed with unilateral or bilateral open angle glaucoma (including pseudo exfoliation or pigment dispersion) or ocular hypertension
3. Subjects who are already on dual drug therapy on any two of the following anti-glaucoma drugs, Timolol (0.5%), Brimonidine (0.1% or 0.2%), Brinzolamide (1%) /Dorzolamide (2%) eye drops with IOP of 22-32 mmHg in at least one eye
4. Best Corrected Visual Acuity (BCVA) of 6/24 or better in study eye(s)
5. Gonioscopy angle of ≥2 in the study eye (s)
6. In case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures
7. Willing to complete all study-related procedures
8. Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed.
|
|
| ExclusionCriteria |
| Details |
1. Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
2. Clinically significant or progressive retinal disease (i.e. retinal degeneration, diabetic retinopathy, retinal detachment or retinal tears) or optic nerve disease.
3. Ocular laser surgery within the 3 months prior to entry.
4. Any abnormality preventing reliable applanation tonometry.
5. Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
6. Recent use of high-dose (>1 gram daily) salicylate therapy.
7. Subject with known allergy or hypersensitivity to the components of the formulation
8. Participation in another clinical trial within past 30 days
9. Other protocol-specified exclusion criteria may apply
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from Baseline in Intraocular Pressure (IOP) |
Baseline to Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in the mean IOP at week 2 and week 6 |
Baseline to week 2, week 6 |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "210"
Final Enrollment numbers achieved (India)="210" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
09/04/2021 |
| Date of Study Completion (India) |
19/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
To be decided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Glaucoma is associated with significant disability and global burden. The study is conducted to assess efficacy, safety and tolerability of triple combination of Timolol 0.5% + Brimonidine 0.2% + Brinzolamide 1% eye drops in patients with open angle glaucoma/ocular hypertension not responding to dual drug therapy. The mean ± SD change in IOP from baseline
to end of study (week 12) was statistically significant (p<0.001). Gonioscopy, biomicroscopy,
perimetry, C:D ratio, and Snellen’s BCVA results were comparable between
baseline and study end. There was statistically significant
improvement in ocular signs and symptoms, as reported by subjects, from
baseline to study end. There were no serious adverse events or
death during the study. Safety
parameters viz, Adverse events, ECG,
Echo, biochemical parameters did not achieve statistical difference between
baseline and Week-12. |