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CTRI Number  CTRI/2010/091/000280 [Registered on: 25/03/2010]
Last Modified On: 23/11/2018
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 inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists. Clinical trial is to study efficacy, safety and tolerability of Moxifloxacin plus Bromfenac eye drops in comparison to Gatifloxacin plus Dexamethasone eye drops. 
Scientific Title of Study
Modification(s)  		 A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Moxifloxacin 0.5% w/v + Bromfenac 0.09% w/v eye drops Vs. Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops in patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.  
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
DPY / CT / 08 / 0903  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)  
Ajanta Pharma Ltd. 
 
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)  
Name  Address 
NIL  NIL 
 
Countries of Recruitment
Modification(s)  		   India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharad Mistry  Dr. Sharad Mistrys Clinic  Sector 3: A-43, Shanti Nagar,Mira Road (E)-401104, Thane, MAHARSHTRA. India
Thane
MAHARASHTRA 		 09821711054

esmile1614@yahoo.co.in 
Dr Yatin P Bhise  Murlidhar Nursing and Maternity Home  Plot No. 22, "Shailaja" ,Suryodaya Housing Society,Ambernath (E) Thane MAHARASHTRA
Thane
MAHARASHTRA 		 09224327297

dryatinb@yahoo.co.in 
Dr Santosh Tupdikar  Nakshatra Netralaya  First floor, Khandare Complex,,Chandranagar-413512, Latur, MAHARSHTRA, India.
Latur
MAHARASHTRA 		 09823069378

santosh_tupdikar@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
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 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists. , (1) ICD-10 Condition: H571||Ocular pain,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Gatifloxacin 0.3% + Dexamathasone 0.1% eye drops  Instill 1 drop four times a day for 7 days 
Intervention  Moxifloxacin 0.5% w/v + Bromfenac 0.09% eye drops   Instill 1 drop four times a day for 7 days 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery at the same time)
2. Written informed consent to participate to the trial. 
 
ExclusionCriteria 
Details  1. Patients < 18 & > 60 years. 2. Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs; 3. Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded) 4. Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs; 5. Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery); 6. Patients who underwent preoperative and/or postoperative intravitreous injection of corticosteroids; 7. Patients who underwent sub-conjunctival injection 8. Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations; 9. Patients who underwent gas tamponade at the surgery; 10. Patients with endogenous uveitis; 11. Patients having corneal epithelial detachment or corneal ulcer in the target eye; 12. Patients who have allergy to corticosteroid drugs; 13. Patients who are required to wear contact lens during the study period; 14. Patients who are scheduled to undergo surgery of the opposite eye during the study period; 15. Patients who are pregnant or may be pregnant or lactating; 16. Patients who have participated in other clinical studies within 3 months.  
 
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 
Slit Lamp Biomicroscopy  Day 1,Day 3, Day 5 and Day 7. 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Conjunctival hyperaemia, corneal and lid oedema, Ocular Infection, pain, photophobia and tearing   Day 1,Day 3, Day 5 and Day 7. 
 
Target Sample Size
Modification(s)  		 Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  		 Phase 3 
Date of First Enrollment (India)
Modification(s)  		 29/03/2010 
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="2"
Days="26" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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 Moxifloxacin 0.5% w/v + Bromfenac 0.09% w/v eye drops Vs. Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops in 100 patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.

 

The primary outcome measures will be assessed by Slit Lamp Biomicroscopy at day 1, Day 3, Day 5 and Day 7. The secondary outcome measures will be assessed by Conjunctival hyperaemia, corneal and lid oedema, Ocular Infection, pain, photophobia and tearing at day 1, Day 3, Day 5 and Day 7.

 
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