| CTRI Number |
CTRI/2010/091/001459 [Registered on: 11/10/2010] |
| Last Modified On: |
22/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical Trial in patients with Glaucoma. Clinical trial is to study efficacy, safety and tolerability of Tafluprost Ophthalmic solution in comparison to Latanoprost eye drop (reference product). |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to evaluate the efficacy, safety and tolerability of Tafluprost Ophthalmic solution 15 mcg/ml Vs. Latanoprost eye drops 0.005 % in patients with Glaucoma.
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| AJ/SC/14/2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD,Charkop Industrial Estate, Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD,Charkop Industrial Estate, Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD,Charkop Industrial Estate, Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent
43/44,ABCD,Charkop Industrial Estate, Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Niveditha. H |
Deeksha Hospital |
387/347, Next to Post Office, B.B. Road,nehrunagar, Yelahanka, -560 064
Bangalore
KARNATAKA |
|
| Dr. Rajendra Jain |
Kamala Eye and Maternity Home |
Indira Complex,60 Feet Road, Bhayander (W)-401101
Thane
MAHARASHTRA |
drrajendrajain@gmail.com |
| Dr Yatin Bhise |
Murlidhar Nursing and Maternity home |
Plot No. 22, "Shailaja",Suryodaya Housing Socienty, Ambernath (E)-400072
Thane
MAHARASHTRA |
09224327297
dryatinb@yahoo.co.in |
| Dr. Nanda Kumar Reddy |
Neha Eye & ENT hospital |
H.No.2-2-24/A/29 & 30,Near Andhra Bank, ,Bagh Amberpet-500013
Hyderabad
ANDHRA PRADESH |
pvnandkumar.reddy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Carewell Multispeciality Hospital |
Approved |
| Deeksha Hospital, 387/347, next to post office,B.B Road, Nehrunagar,Banalore 560064. |
Approved |
| Jagruti - Independent Ethics Committee |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400050 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Glaucoma, (1) ICD-10 Condition: H409||Unspecified glaucoma, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Latanoprost Eye Drop |
One drop for 4 weeks |
| Intervention |
Tafluprost Ophthalmic solution |
One drop for 4 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with diagnosis of glaucoma. |
|
| ExclusionCriteria |
| Details |
Pregnant or nursing females.
Patients with exfoliation glaucoma and neovascular glaucoma.
Patients with diabetic retinopathy.
Patients with advanced visual field loss (MD <-15dB).
Excessive myopia (<-6D).
Any corneal abnormality or other condition preventing reliable applanation tonometry.
Presence of any external disease and inflammation of the eye.
History of refractive surgery.
History of laser trabeculoplasty, filtering surgery, trabeculotomy, cataract surgery, and other intraocular surgery.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Blurred Vision, Halos around Lights, Pain and Redness of Eye. |
Day 1, week 1, week 2 and week 4. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Overall global assessment of efficacy and tolerability |
Week 4 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
22/10/2010 |
| 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
Modification(s)
|
Years="0"
Months="1"
Days="24" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, comparative, Double blind and multicentric clinical study comparing the safety and efficacy of Tafluprost Ophthalmic solution Vs. Latanoprost eye drop in 200 patients with Glaucoma. Date of first enrollment will be 13 Oct 2010.
Primary efficacy parameters will be mean Values of IOP levels and Ocular signs and symptoms such as Blurred vision, halos around lights, pain and redness of eyes will be assessed at baseline visit, all follow up visits and at final visit. |