| CTRI Number |
CTRI/2017/04/008299 [Registered on: 06/04/2017] Trial Registered Prospectively |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Nepafenac Ophthalmic Suspension 0.3% w/v compared to Bromfenac Ophthalmic Solution 0.09% w/v in the treatment of Pain and Inflammation post Cataract Surgery. |
|
Scientific Title of Study
|
A Multicentric, Double Blind, Randomized, Active Control, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Nepafenac Ophthalmic Suspension 0.3 % w/v Vs. Bromfenac Ophthalmic Solution 0.09% w/v in the treatment of Patients with Pain and Inflammation in the Eye associated with Cataract Surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/16/07 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalpit Shah |
| Designation |
Principal Investigator |
| Affiliation |
B. J. medical Colloge and Civil Hospital |
| Address |
M & J Western regional Institute of Ophthalmology,
B. J. medical Colloge and Civil Hospital, Asarwa, Ahmedabad - 380016. Gujarat, India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825296016 |
| Fax |
|
| Email |
dr_kps@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Vice President R&D and Reg. Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-66062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Vice President R&D and Reg. Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-66062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
|
Source of Monetary or Material Support
|
| Ajanta Pharma Limited
Ajanta Pharma Limited,
Plot no. 43 AB & 44 BCD,
Govt. Industrial Estate, Charkop,
Kandivali (W),
Mumbai – 400067 |
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate, Kandivli (West) Mumbai-400067 Maharashtra. India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Parekh |
Bhagwan mahaveer Jain Hospital |
Department of Opthalmology,
Millers Road, Vasathnagar, Bangalore - 560062.
Bangalore
KARNATAKA |
9945544744
eyetrials@gmail.com |
| Dr Kalpit Shah |
BJ Medical College & Civil Hospital |
Department of Ophthalmology
M & J Western regional Institute of Ophthalmology, Asarwa, Ahmedabad - 380016. Gujarat, India
Ahmadabad
GUJARAT |
9825296016
dr_kps@yahoo.co.uk |
| Dr Saroj Sahdev |
BYL Nair Ch. Hospital and TN Medical College |
Department of Ophthalmology, Dr. AL Nair road, Mumbai Central, Mumbai- 400008
Mumbai
MAHARASHTRA |
9820512629
sisahdev@hotmail.com |
| Dr Nitin Batra |
Christian Medical College and Hospital |
Department of Ophthalmology,
brown Road, Ludhiana, Punjab - 141008.
Ludhiana
PUNJAB |
9815333665
nbatra2001@gmail.com |
| Dr VVL Narasimha Rao |
Dr. R.S.P.R. Government Regional Eye Hospital |
Department of Ophthalmology,
3rd Unit, Opp. Bulliya College, Resavapuvanipalem, Viskhapatnam - 530013, Andhra Pradesh.Visakhapatnam
ANDHRA PRADESH
Visakhapatnam
ANDHRA PRADESH |
9885268979
drvvlclinicalresearch@gmail.com |
| Dr B Kantha Sree |
Gandhi Hospital |
Deapartment of ophthalmology, Gandhi Hospital, Musheerabad, Secunderabad-500003.
Hyderabad
ANDHRA PRADESH |
9000986199
kanthasreebugge@gmail.com |
| Dr Deepika Singhal |
GMERS Medical College and Civil Hospital |
Department of Ophthalmology,
Sola ophthalmology Department, Nr. Gujarat
High Court,S. G. highway, Sola, Alunedabad-380061.Gujarat.
Ahmadabad
GUJARAT |
9426541167
deepika1103@yahoo.com |
| Dr Mohua Mazumdar |
IPGME&R, SSKM Hospital |
Department of Ophthalmology,
244 A J C Bose Road, Kolkata -700020.
Kolkata
WEST BENGAL |
9830682007
mazumder_mahua@yahoo.com |
| Dr Vaggu Sree Kumar |
Kakatiya Medical College |
Department of Ophthalmology, Rangampet Street, Warangal 506007, Telangana, India
Warangal
ANDHRA PRADESH |
9394058999
vaggusreekumar@gmail.com |
| Dr Ashish Saxena |
Kanoria Hospital & Research Center |
Department of Ophthalmology, Airport-gandhi Nagar Highway, Bhat Village, GandhiNagar-382428.
Gandhinagar
GUJARAT |
9824042699
drashishsaxenacr@gmail.com |
| Dr Sudhir Kumar Garg |
Maharaj Agrasen Hospital |
Department of Ophthalmology, West Punjabi Bagh, New Delhi-110026.
New Delhi
DELHI |
981141119
drskgi2610@gmail.com |
| Dr Anil Agarwal |
Marwari Hospital & Research Centre |
Department of Ophthalmology, SJ Road, Athgaon, Guwahati-781 008, Assam
Kamrup
ASSAM |
9864093366
dranil03@gmail.com |
| Dr Dinesh Kanth |
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital |
Department of Ophthalmology, Srikakulam-532001, A.P,India.
Srikakulam
ANDHRA PRADESH |
8500949101
dkmedico17@gmail.com |
| Dr Kumudini Sharma |
Sanjay Gandhi Postgraduate Institute of Medical sciences |
Department of Ophthalmology,
Raebareli road,
Lucknow - 226014.
Uttar Pradesh
Lucknow
UTTAR PRADESH |
7408890080
drpradhyumman@gmail.com |
| Dr Jigeesh Nareshbahi Desai |
Sanjivani Superspecialty Hospital |
Department of Ophthalmology,
New Uday Park Society, Nr. Sunrise Park,
Vastrapur, Ahmedabad-380015.
Ahmadabad
GUJARAT |
9426001724
dr.jigeeshdesai@gamial.com |
| Dr Ashwini K V |
Sapthagiri Institute of Medical sciences and research center |
Department of Ophthalmology,
# 15, Chikkasandra, Hesaraghatta main road, bangalore - 560090. Karnataka
Bangalore
KARNATAKA |
9731799114
ashwini_kulenur@yahoo.com |
| Dr Shailendra Deshmukh |
Sassoon General Hospital |
Department of Ophthalmology, Jayaprakash Narayan Road, Near Pune Railway Station,Pune-411001. Maharashtra.
Pune
MAHARASHTRA |
9822218540
dr.deshmukh.shailendra@gmail.com |
| Dr Rajesh Khipar Lohana |
Saviour Multispecialty Hospital |
Deaprtment of Ophthalmology,
Near Bharat petrol Pump, Near Lakhudi talav, Stadium road, Navrangpura, Ahmedabad- 380014.
Ahmadabad
GUJARAT |
9825064890
rajeshluhana@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| Ethics Committee, Kanoria Hospital and Research Centre |
Approved |
| Ethics Committee, Saptahgiri Institute of Medical Sciences and Research Center |
Submittted/Under Review |
| Institutional Ethics Committee BJ Govt. Medical College & Sassoon General Hospital |
Submittted/Under Review |
| Institutional Ethics Committee of B.J. Medical College of Civil Hospital, |
Submittted/Under Review |
| Institutional Ethics Committee, Christian Medical College and Hospital |
Approved |
| Institutional Ethics Committee, Kakatiya Medical College |
Approved |
| Institutional Ethics Committee, Maharaj Agrasen Hospital |
Approved |
| Institutional Ethics Committee, Marwari Hospital & Research Centre |
Approved |
| Institutional Ethics Committee, Sanjay Gandhi Postgraduate Institute of Medical sciences |
Not Applicable |
| Institutional Ethics Committee, T.N.Medical College & B.Y.L.Nair Charitable Hospital |
Submittted/Under Review |
| Institutional Ethics Committee,Rajiv Gandhi Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee_Bhagwan Mahaveer Jain Hospital |
Submittted/Under Review |
| Institutional Ethics Committee_Gandhi Medical College |
Approved |
| Institutional Ethics Committee_GMERS Medical College |
Submittted/Under Review |
| Institutional Ethics Committee_King George Hospital |
Approved |
| IPGME&R Research Oversight Committee |
Submittted/Under Review |
| Sanjivani Hospital Ethics Committee |
Submittted/Under Review |
| Saviour Hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H590||Disorders of the eye following cataract surgery, Pain and Inflammation in the Eye associated with Cataract Surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bromfenac Ophthalmic Solution 0.09% w/v |
One drop, once daily for 14 days |
| Intervention |
Nepafenac Ophthalmic Suspension 0.3 % w/v |
One drop, once daily for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female patients of age 18 - 70 years (Both inclusive).
2. Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens.
3. Voluntary willingness to give written informed consent prior to participation in trial.
|
|
| ExclusionCriteria |
| Details |
1. Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit.
2. Use of any form of steroids -topical, inhaled or systemic steroids within 14 days prior to surgery or local or oral NSAIDs within 7 days of surgery.
3. History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye.
4. Pregnant and lactating women.
5. Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article.
6. Subjects with bleeding tendency, dry eye, rheumatoid arthritis, ocular surface disease including epithelial problems.
7. Subject with any surgery which converted from phacoemulsification to extra capsular surgery.
8. Patients with history of ocular surgery, inflammatory eye disease, ocular infection, congenital ocular anomalies, ocular trauma or current signs and symptoms that were associated with these or other ocular conditions.
9. Lens pseudoexfoliation syndrome with glaucoma or zonular compromise or previous ocular trauma.
10. Patients were also excluded if their IOP could not be reliably measured or had planned multiple surgical procedures, lens pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye, ocular or systemic inflammatory or diabetic disease, or previous ocular trauma to the operative eye.
11. Patient with Diabetic Retinopathy, Glaucoma and any other Neurological condition.
12. Any other condition(s) that may affect the procedure of the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ocular inflammation as assessed by the investigator during slit lamp examination |
Day 1,Day 7,Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ocular pain will be assessed using a categorical scale.
Percentage of patients Pain Free at each visit post cataract surgery. |
Day 1,7,14 |
|
|
Target Sample Size
|
Total Sample Size="278"
Sample Size from India="278"
Final Enrollment numbers achieved (Total)= "248"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/04/2017 |
| Date of Study Completion (India) |
04/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/10/2017 |
|
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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is A Multicentric, Double Blind, Randomized,
Active Control, Parallel Group Comparative Study to Evaluate the Efficacy,
Safety and Tolerability of Nepafenac Ophthalmic Suspension 0.3 % w/v Vs.
Bromfenac Ophthalmic Solution 0.09% w/v in the treatment of Patients with Pain
and Inflammation in the Eye associated with Cataract Surgery.
Primary objective of this study is to assess Ocular
inflammation. Secondary objective of the study is to assess the Ocular pain and
number of patients pain free at each visit post cataract surgery. |