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CTRI Number  CTRI/2018/05/013693 [Registered on: 04/05/2018] Trial Registered Prospectively
Last Modified On: 12/02/2019
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 check the effect and safety of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v compared with Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v in patients suffering with ocular itching associated with allergic conjunctivitis. 
Scientific Title of Study   “A Phase III, Multicenter, Comparative, Randomized, Double blind, Two arm, Parallel group Clinical Study to evaluate Efficacy and Safety of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v as compared with Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v for the treatment of Ocular Itching associated with Allergic Conjunctivitis.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
APL/CT/17/02  Protocol Number 
Version No.01, Aug 01, 2017  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A Tarakeswara Rao 
Designation  Principal Investigator 
Affiliation  Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital 
Address  Department of Ophthalmology, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital, Srikakulam - 532001 Andhra Pradesh

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  8942279033  
Fax    
Email  drtarakrims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailesh Singh 
Designation  Sr Vice President R&D and Regulatory Affairs 
Affiliation  Ajanta Pharma Limited  
Address  Ajanta Pharma Ltd Advent 43AB/44BCD, Charkop Industrial Estate, Kandivli West. Mumbai

Mumbai (Suburban)
MAHARASHTRA
400067
India 
Phone  2266062111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailesh Singh 
Designation  Sr Vice President R&D and Regulatory Affairs 
Affiliation  Ajanta Pharma Limited  
Address  Ajanta Pharma Ltd Advent 43AB/44BCD, Charkop Industrial Estate, Kandivli West. Mumbai

Mumbai (Suburban)
MAHARASHTRA
400067
India 
Phone  2266062111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Source of Monetary or Material Support  
Ajanta Pharma Ltd., Advent 43 AB/44BCD, Charkop Industrial Estate, Kandivli West.Mumbai. Maharashtra - 400067 
 
Primary Sponsor  
Name  Ajanta Pharma Ltd 
Address  Advent 43 AB/44BCD, Charkop Industrial Estate, kandivli West.Mumbai. Maharashtra 400067 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neeraj Chowdhry  Ajanta Research Centre  Ajanta Research Centre, Ajanta Hospital & IVF Centre, 765, ABC Complex, Kanpur Road, Alambagh, Lucknow-226005
Lucknow
UTTAR PRADESH 		 9839121338

neerajtaurus3@gmail.com 
Dr Kalpit Pravinbhai Shah  B.J. Medical College  M&J Western Regional Institute of Ophthalmology, B.J. Medical College, Civil Hospital Campus, Ahmedabad-380016, Gujarat, India.
Ahmadabad
GUJARAT 		 9825296016

dr_kps@yahoo.co.uk 
Dr Nitin Batra  Christian Medical College and Hospital  Department of Ophthalmology, Christian Medical College and Hospital, Ludhiana, Punjab - 141008
Ludhiana
PUNJAB 		 09815333665

nbatra2001@gmail.com 
Dr Deepika Singhal  Department of Ophthalmology GMERS Medical College & Civil Hospital  Department of Ophthalmology,GMERS Medical College & Civil Hospital,Near New Gujarat High court, S G Highway Sola, Ahmedabad-380061, Gujarat, India
Ahmadabad
GUJARAT 		 9426541167

deepika1103@yahoo.com 
Dr B Kantha Sree  Gandhi Hospital  Department of Ophthalmology, Gandhi Hospital, Musheerabad, Secunderabad, Telangana-500003
Hyderabad
ANDHRA PRADESH 		 9618888684

kanthasreebagge@gmail.com 
Dr Hemaxi Pratap Desai  GCS Medical College  GCS Medical College, Hospital and Research Centre, Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad-380025, Gujarat, India.
Ahmadabad
GUJARAT 		 7966048000

ruhani91@yahoo.co.in 
Dr Shalini Mohan  GSVM Medical College  Department of Ophthalmology, Swaroop Nagar, Kanpur-208002, UP. India
Kanpur Nagar
UTTAR PRADESH 		 9506740966

drshalinimohan@gmail.com 
Dr Santosh Kumar Mahapatra  J P M Rotary Club of Cuttack Eye Hospital & Research Institute  JPM Rotary Club of Cuttack Eye Hospital & Research Institute, CDA, Sector-VI, Markat Nagar, Cuttack-753014 Odisha
Cuttack
ORISSA 		 9437017762

santu_k74@rediffmail.com 
Dr Smitha K S  KLES Dr Prabhakar Kore Hospital & Medical Research Centre  Department of Ophthalmology, KLES Dr Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar, Belgavi - 590010
Belgaum
KARNATAKA 		 09964319436

Drsmithaks@gmail.com 
Dr Sudhir Kumar Garg  Maharaja Agrasen Hospital  Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi-26
New Delhi
DELHI 		 981141119

Drskgi2610@gmail.com 
Dr Anil Agarwal  Marwari Hospital and Research Centre  Department of Ophthalmology, S. J. Road, Athgaon, Guwahati-781008
Kamrup
ASSAM 		 9864093366

dranil03@gmail.com 
Dr Daxa Pande  Medilink Hospital Research Centre  Medilink Hospital Research Centre, Basement Medilink Hospital, Nr. Shyamal Cross Road, 132 ft. Ring Road, Satellite, Ahmedabad-380015, Gujarat, India
Ahmadabad
GUJARAT 		 07926760646
07926743051
medilinkresearchcentre@yahoo.com 
Dr A Tarakeswara Rao  Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital  Department of Ophthalmology, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH 		 9441873644

drtarakrims@gmail.com 
Dr Tamojit Chatterjee  Regional Institute of Ophthalmology, Medical College and Hospital  Regional Institute of Ophthalmology, Medical College and Hospital, 88 College Street, Kolkata-700073
Kolkata
WEST BENGAL 		 9477371192

pralay.87@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical College  Approved 
Ethics Committee Marwari Hospital & Research Centre  Submittted/Under Review 
Ethics Committee, Ajanta Hospital & IVF Centre  Approved 
Institutional Ethics Committee GMERS Medical College and Civil Hospital  Approved 
Institutional Ethics Committee, Maharaja Agrasen Hospital  Approved 
Institutional Ethics Committee, B.J. Medical College & Civil Hospital  Submittted/Under Review 
Institutional Ethics Committee, Christian Medical College & Hospital  Submittted/Under Review 
Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital  Approved 
Institutional Ethics Committee, GCS Medical College, Hospital & Research Centre  Submittted/Under Review 
Institutional Ethics Committee, JPM Rotary Club of Cuttack Eye Hospital and Research Institute  Approved 
Institutional Ethics Committee, KLES Dr Prabhakar Kore Hospital & Medical Research Centre  Submittted/Under Review 
Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital  Approved 
Institutional Ethics Committee, Regional Institute of Ophthalmology  Submittted/Under Review 
Medilink Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Ocular Itching associated with Allergic Conjunctivitis, (1) ICD-10 Condition: H108||Other conjunctivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v   Instill one drop in each affected eye once a day for 14 days 
Intervention  Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v  Instill one drop in each affected eye once a day for 14 days. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female subjects, aged 10 years to 65 years (both inclusive).
2. Treatment naïve subjects with diagnosis of ocular itching associated with allergic conjunctivitis in one or both the eyes.
3. Subjects willing to discontinue contact lens wear for at least 72 hours prior to screening visit and throughout the study.
4. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures
 
 
ExclusionCriteria 
Details  1. Subjects with any contraindications or hypersensitivities to the use of the study medication or their components.
2. Subjects who are blind or subjects with single eye will be excluded from the study.
3. Subjects with Visual acuity of 20/80 in any eye.
4. Subjects with known case of persistent dry eye syndrome or currently on treatment for dry eyes.
5. Subjects with Vernal Keratoconjunctivitis (VKC), Atopic Keratoconjunctivitis (AKC) and Giant Papillary Conjunctivitis (GPC) will be excluded from the study.
6. Subjects with presence of ocular infection (bacterial, viral or fungal) or history of ocular herpes within 30 days of screening visit.
7. Subjects with presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
8. Subjects with chronic ocular degenerative condition or active intraocular inflammation that could worsen during the study.
9. Subjects with known case of glaucoma will be excluded from the study.
10. Subjects with known case of ocular surgery within 6 months or scheduled to undergo ocular surgery during the study period.
 
 
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 
Change from baseline in ocular itching score on day 1 (Time Frame: 3, 5 and 7 minutes of post first instillation of IMP), day 2 [at 24 hrs (+1 hr) post first instillation of IMP], 7 and 14.  At the end of Day 1, 7 and 14 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in conjunctival hyperemia grade on day 1, 7 and 14.
Change from baseline in tearing score at the end of day 2,7 and 14.
Change from baseline in chemosis score at the end of day 2, 7 and 14. 		 At the end of Day 1, 2, 7 and 14 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "219"
Final Enrollment numbers achieved (India)="219" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/05/2018 
Date of Study Completion (India) 24/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 24/10/2018 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a “A Phase III, Multicenter, Comparative, Randomized, Double blind, Two arm, Parallel group Clinical Study to evaluate Efficacy and Safety of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v as compared with Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v for the treatment of Ocular Itching associated with Allergic Conjunctivitis.”

Primary objective is to evaluate the efficacy of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v compared with Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v for the treatment of ocular itching associated with Allergic Conjunctivitis.

  

Secondary objective is to evaluate the safety of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v compared with Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v for the treatment of ocular itching associated with Allergic Conjunctivitis.

 
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