| CTRI Number |
CTRI/2015/01/005399 [Registered on: 14/01/2015] Trial Registered Prospectively |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to Study the Efficacy, Safety and Tolerability of Bepotastine Besilate Ophthalmic Solution Vs. Olopatadine Hydrochloride Ophthalmic Solution in Subjects Suffering from Allergic Conjunctivitis. |
|
Scientific Title of Study
|
A Clinical Trial to Study the Efficacy, Safety and Tolerability of Bepotastine Besilate Ophthalmic Solution
Vs. Olopatadine Hydrochloride Ophthalmic Solution in Subjects Suffering from Allergic Conjunctivitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DPY/CT/08/0801;Version No.: 5.0 dated 05.07. 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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
400 067
India |
| Phone |
022-6062111 |
| Fax |
022-6061200 |
| Email |
shailesh.singh@ajantapharma.com |
|
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
400 067
India |
| Phone |
022-6062111 |
| Fax |
022-6061200 |
| 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
400 067
India |
| Phone |
022-6062111 |
| Fax |
022-6061200 |
| Email |
shailesh.singh@ajantapharma.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43
AB/44CD, Charkop Industrial Estate,
Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehasis Basu |
Apollo Gleneagles Hospitals |
Ophthalmology department, Multi specialty division,1st floor,Apollo Gleneagles Hospital,Canal Circular Road, Kolkata-700054
Kolkata
WEST BENGAL |
91-9433361416
Sbasu2003@doctors.net.uk |
| Dr Sujata Navare |
Aster Aadhar Hospital (Prerana Hospital Ltd.) |
Aster Aadhar Hospital
(Prerana Hospital Ltd),
R.S. No. 628,
B Ward,
Near Shastri Nagar,
KMT Workshop,
Kolhapur-416012.
Kolhapur
MAHARASHTRA |
91-9225068511
sujatanavare.aacr@gmail.com |
| Dr VVL Narasimha Rao |
Govt Regional Eye Hospital |
Superintendent room, Govt.Regional Eye Hospital, Resapuvanipalem
Andhra Medical College/King George Hospital,
Visakhapatnam-530013
Visakhapatnam
ANDHRA PRADESH |
91-9885268979
vvlclinicalresearch@gmail.com |
| Dr Pradeep Saraf |
Health point Hospital |
Health point multi-Speciality Hospital,
21, Prannath Pandit street,
Kolkata-700 020.
Kolkata
WEST BENGAL |
91-8420011311
pksaraf@myeyeworld.com |
| Dr Prasenjit Maiti |
IPGMER & SSKM Hospital |
IPGMER & SSKM Hospital,
244 A.J.C Bose Road,
Kolkata-700020
Kolkata
WEST BENGAL |
91-9831044795
sreejitamaiti@gmail.com |
| Dr Sanjiv Kumar Gupta |
King George Medical University |
Department of ophthalmology(south wing)
1st floor, 1st room,
King George’s medical college chowk,Lucknow-226003
Lucknow
UTTAR PRADESH |
91-9532998211
Sanjiv204@gmail.com |
| Dr Nayana Potdar |
Lokamanya Tilak Muncipal General Hospital |
Department of Opthalmology, Second Floor, OPD Building ,Near Gate Number 7,Lokmanya Tilak Municipal general Hospital,Sion-west
Mumbai-400022
Mumbai
MAHARASHTRA |
91-9869120570
nayanapotdar@yahoo.com |
| Dr Pankaj Gupta |
Post Graduate Institute of Medical Education and Research |
Post Graduate Institute of Medical Education and Research,
Sector 12,
Chandigarh-160012.
Chandigarh
CHANDIGARH |
91-9876436810
gupta.pankaj@pgimer.edu.in |
| Dr V Dinesh Kanth |
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital. |
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital,
Srikakulam-532001.
Srikakulam
ANDHRA PRADESH |
91-8500949101
dkmedico17@gmail.com |
| Dr Anju Kochar |
S.P. Medical College and A.G. of Hospital |
S.P. Medical College and A.G. of Hospital,
Bikaner-334003.
Bikaner
RAJASTHAN |
91-9414452209
dranjukochar@yahoo.co.in |
| Dr Smita P Patil |
Seth G.S Medical College & KEM Hospital |
OPD Number 36,Ground Floor,Department of Ophthalmology, Old Building
Seth GS Medical College and KEM hospital,Acharya Donde Marg, Parel,
Mumbai 400 012.
Mumbai
MAHARASHTRA |
91-8286021365
drsmitap@yahoo.co.in |
| Dr Nishit Dhoka |
SR Kalla Memorial Gastro and General Hospital |
Research Department,
Third Floor,
SR Kalla Memorial Gastro and General Hospital,
78-79 Dhuleshwar Garden,
Behind HSBC Bank,
Sardar Patel Marg,
C Scheme,
Jaipur-302001
Jaipur
RAJASTHAN |
91-9660038297
ndhoka@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Aster Aadhar Ethics Committee |
Approved |
| Ethics Committee, S. P. Medical College and A.G. Hospitals |
Approved |
| Health Point Ethics Committee |
Approved |
| Institutional Ethics Committee Apollo Gleneagles Hospital |
Approved |
| Institutional Ethics committee, King George’s Medical College |
Approved |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Goverment General Hospital |
Approved |
| Institutional Ethics Committee, Seth G.S Medical College & KEM Hospital |
Not Applicable |
| Institutional Ethics Committee- HR, Lokamanya Tilak Municipal Medical College, Sion, Mumbai-22 |
Approved |
| Institutional Ethics Committee- Human Resource |
Approved |
| IPGME&R Research Oversight Committee |
Not Applicable |
| S R Kalla Memorial Ethical Committee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H108||Other conjunctivitis, Subjects suffering from Allergic Conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bepotastine besilate 1.5%ophthalmic solution |
Instill one drop into the affected eye(s) twice a day for 3 weeks |
| Comparator Agent |
Olopatadine hydrochloride 0.1% ophthalmic solution |
One drop in each affected eye two times per day for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject with sign and symptoms of allergic conjunctivitis like ocular itching, eye lid swelling, tearing, photophobia, watery discharge, diagnosis of allergic conjunctivitis will be confirmed by conjunctival smear examination.
2.Freshly diagnosed subject or Subjects who are previously diagnosed and on treatment of allergic conjunctivitis will undergo for 3 days wash out period
3.Subject willing to sign informed consent form (ICF) prior to any screening procedure. For Minor subject (age below 18yrs) LAR (Legally Acceptable Representative) should be taken with assent.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs.
2.Use of disallowed medications during the period indicated prior to study enrollment or during the study.
3.Subject with dry eyes should be excluded from the trial
4.Subject with Schirmer 10 should be excluded from the study.
5.Subject who are blind or subject with single eye.
6.Subjects who have planned surgery during trial period.
7.Subject with Vernal Keratoconjunctivitis should be excluded from the trial.
8.Subjects having corneal epithelial detachment or corneal ulcer in the target eye.
9.Subjects who are required to wear contact lens during the study period.
10.Subjects who are pregnant or may be pregnant or lactating.
11.Subjects who have participated in other clinical studies within 3 months.
12.Any ocular condition that, in the opinion of the investigator, could affect the subject’s safety or trial parameters.
13.Known contraindications or sensitivities to the study medication or its components.
14.Other patients who in the opinion of the investigator/sub investigator were inappropriate for the study participation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution in Subjects Suffering from Allergic Conjunctivitis. |
Day 0,1 week,2 week and 3 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety and tolerability of Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution.
Global assessment of study medications by Subjects and Investigators.
|
Day 0,1 week,2 week and 3 week. |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/01/2015 |
| 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="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 Comparative, Randomized, Double blind, Parallel group and Non Crossover Multicentric Clinical Study with Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution in Subjects Suffering from Allergic Conjunctivitis.
Ocular allergies are very common and range in intensity from mild, self-resolving, acute conditions to serious, chronic disease that can severely affect vision.
The efficacy parameter is primarily focused on ocular itching,conjuctival redness.
|