| CTRI Number |
CTRI/2010/091/000279 [Registered on: 26/03/2010] |
| Last Modified On: |
24/11/2018 |
| 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 Bacterial conjunctivitis. Clinical trial is to study efficacy, safety and tolerability of Besifloxacin ophthalmic suspension in comparison to Moxifloxacin ophthalmic solution (reference product). |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Besifloxacin ophthalmic suspension 0.6% Vs Moxifloxacin ophthalmic solution 0.5% in patients with Bacterial conjunctivitis. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| APL/CT/09/034 |
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 (W)
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 (W)
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 (W)
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
43AB/44CD, 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 Rajendra Jain |
Kamala Eye & Maternity Home |
Indira Complex, ,60 Feet Road, Bhayandar (W), Thane
Thane
MAHARASHTRA |
09920678238
drrajendrajain@gmail.com |
| Dr Yatin P Bhise |
Murlidhar Nursing and Maternity Home |
Plot No. 22, "Shailaja",Suryodaya Housing Society,Ambernath (E)
Thane
MAHARASHTRA
India.
Thane
MAHARASHTRA |
09224327297
dryatinb@yahoo.co.in |
| Dr. Santosh Tupdikar |
Nakshatra Netralaya |
First floor, Khandare Complex,,Chandranagar,-413512
Latur
MAHARASHTRA |
09823069378
santosh_tupdikar@yahoo.co.in |
| Dr Shafeeulla Tamboli |
Rani Masaheb Rotary Eye Hospital and Research Center |
Rotary Marg,,Dondaicha, Dhule,
Dhule
MAHARASHTRA |
09371079462
shafitamboli@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Jagruti Independent Ethics Committee Bandra Mumbai 400 050 |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400 050 |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400 050 |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400 050 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Bacterial conjunctivitis, (1) ICD-10 Condition: H108||Other conjunctivitis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Besifloxacin ophthalmic suspension 0.6% |
Instill 1 drop in both eyes 3 times daily for 5 days |
| Comparator Agent |
Moxifloxacin ophthalmic solution 0.5% |
Instill 1 drop in both eyes 3 times daily for 5 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
2. Patients providing written informed consent to participate in the trial.
|
|
| ExclusionCriteria |
| Details |
1. Patients < 18 & > 60 years.
2. Pregnant or nursing females
3. Known hypersensitivity to fluroquinolones or to any of the study ingredients.
4. Use of any antibiotic within 72 hours of treatment.
5. Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
6. Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
|
|
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 |
| The primary outcome measures will be slit lamp biomicroscopy, tear culture examination, ophthalmoscopic examination, redness of the eyes, eye pain, blurred vision, sensitivity to light, burning or itching of the eye, a scratchy feeling in the eye and discharge. |
Day 0 and Day 5. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Safety and tolerability |
Day 5 |
| Global assessment |
Day 5 |
|
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)
|
27/04/2010 |
| 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="3"
Days="0" |
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 comparative, randomized, double blind, multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Besifloxacin ophthalmic suspension 0.6% Vs Moxifloxacin ophthalmic solution 0.5% (Reference Drug) in 200 patients with Bacterial conjunctivitis in india. Date of first enrollment will be 27 April 2010.
The primary outcome measures will be slit lamp biomicroscopy, tear culture examination, ophthalmoscopic examination, redness of the eyes, eye pain, blurred vision, sensitivity to light, burning or itching of the eye, a scratchy feeling in the eye and discharge at day 0 and 5. Secondary outcome will be safety and tolerability and global assessment at day 5. |