| CTRI Number |
CTRI/2011/11/002105 [Registered on: 04/11/2011] Trial Registered Prospectively |
| Last Modified On: |
24/09/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Trial to study the effects of two drugs travoprost & brimonidine/timolol combination in patients with kanchbind (high pressure in eyes). |
|
Scientific Title of Study
|
A comparative study on safety & efficacy of travoprost & brimonidine/timolol fixed combination in patients of primary open angle Glaucoma at ophthalmology department of Peoples College of Medical Sciences & Research Centre Bhanpur
Bhopal. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
rekha mehani |
| Designation |
PG student |
| Affiliation |
Peoples college of medical sciences and research center bhanpur Bhopal |
| Address |
51,52 chanakyapuri J.K.Road bhopal
Peoples college of medical sciences and research center bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9827539825 |
| Fax |
|
| Email |
drrekhasanjay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSDShukla |
| Designation |
Professor & H. O. D. |
| Affiliation |
Peoples college of medical sciences and research center bhanpur Bhopal |
| Address |
Department of pharmacology
Peoples college of medical sciences and research center bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9893733897 |
| Fax |
|
| Email |
shukladrsd9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
rekha mehani |
| Designation |
PG student |
| Affiliation |
Peoples college of medical sciences and research center bhanpur Bhopal |
| Address |
51,52 chanakyapuri J.K.Road bhopal
Peoples college of medical sciences and research center bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9827539825 |
| Fax |
|
| Email |
drrekhasanjay@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| 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 Rekha mehani |
at ophthalmology dept. of PCMS & RC Bhopal. |
at ophthalmology dept. of PCMS & RC Bhopal.
Â
Bhopal
MADHYA PRADESH |
9827539825
drrekhasanjay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples college of medical sciences and research center bhanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
brimonidine/timolol |
brimonidine/timolol eye drops twice daily for 12weeks
|
| Comparator Agent |
travoprost |
travoprost eye drops once daily for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
IOP in each eye more than 21 mm Hg.
Best corrected visual acuity 6/18 or better in each eye.
|
|
| ExclusionCriteria |
| Details |
Progressive or functionally significant visual fields loss within past year.
Pregnant women or lactating mothers.
Patients with corneal abnormalities or any other conditions that prevent applanation tonometry.
Patients with ocular infection, advanced cataract, ocular inflammation.
Patients of bronchial asthma & cardiac disease. Â
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual acuity
IOP
Slit lamp Bimicroscopy for optic disc evaluation
Gonioscopy
Perimetry |
4, 8, 12 wks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual acuity
IOP
Slit lamp Bimicroscopy for optic disc evaluation
Gonioscopy
Perimetry
|
4, 8, 12 wks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/11/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
•Glaucoma--------Second leading cause of blindness, silent thief of sight. • Progressive optic neuropathy with degeneration of retinal ganglion cells. • Irreversible blindness if left undiagnosed & untreated • Normal IOP ® 10-20mm Hg. • Data from the Early Manifest Glaucoma Trial (EMGT) have shown that an additional 1 mm Hg of IOP lowering reduces the risk of glaucoma progression by 10 %.•At the baseline visit, patients will be randomized into 2 groups after investigations and diagnosis•12.3% of total blindness • •Vision loss range from 5.2 to 6.7 million • •Prevalence-1% to 4% in people over 40yrs in Asia • •¯ in IOP delays damage to optic nerve & visual field • •¯ in IOP by 30% ¯ disease progression from ~35 to 10% . Travoprost is will be given to one group & Brimonidine + timolol to another group • Follow-up to be done - at 2, 4, 12 wks. •IOP measurement & fundus examination will be done at every visit. •Perimetery will be repeated monthly.
|