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CTRI Number  CTRI/2018/09/015810 [Registered on: 24/09/2018] Trial Registered Prospectively
Last Modified On: 14/03/2019
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 study of Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops for the treatment of Subjects 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 Fixed dose combination of Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops compared with Alcaftadine Ophthalmic Solution 0.25% w/v for the treatment of Subjects with Ocular Itching associated with Allergic Conjunctivitis.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
APL/CT/17/05  Protocol Number 
V01/22-Dec-17  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr B Kantha Sree 
Designation  Principal Investigator 
Affiliation  Gandhi Hospital Secunderabad, Telangana 
Address  Department of Ophthalmology, Gandhi Hospital, Musheerabad, secunderabad-500003

Hyderabad
ANDHRA PRADESH
500003
India 
Phone  9000986199  
Fax    
Email  kanthasreebugge@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

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

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 = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Kartik Ambade  Arneja Heart and Multispeciality Hospital  Dr Ajay kartik Ambade, Arneja Heart and Multispeciality Hospital, 123, Ramdaspeth, Nagpur-440010, Maharashtra.
Nagpur
MAHARASHTRA 
919823178466

dr_ajayambade@rediffmail.com 
Dr Shah Kalpit Pravinbhai  B. J Medical College & Civil Hospital  M & J Institute of Ophthalmology, Western Regional Institute of India, B. J. Medical College, Civil Hospital Campus, Ahmedabad- 380016, Gujarat.
Ahmadabad
GUJARAT 
9725769355

dr_kps@yahoo.co.uk 
Dr Amit Jagyasi  Chandulal Chandrakar Memorial Medical College & Hospital  Chandulal Chandrakar Memorial Medical College & Hospital, Kanchandur, Kurud road, Durg, Chhattisgharh 490024.
Durg
CHHATTISGARH 
919158592177

cmmdurg.research@gmail.com 
Dr B Kantha Sree  Gandhi Hospital  Dept. of Ophthalmology, Gandhi Hospital,Musheerabad, Secunderabad-500003
Hyderabad
ANDHRA PRADESH 
9000986199

kanthasreebagge@gmail.com 
Dr Hemaxi Pratap Desai  GCS Medical College, Hospital and Research Centre  Dept. of Ophthalmology, GCS Medical College, Hospital and Research Centre, Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad-380025, Gujarat, India.
Ahmadabad
GUJARAT 
919898065645
917922201915
ruhani91@yahoo.co.in 
Dr Shalini Mohan  GSVM Medical College  Department of Ophthalmology, Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH 
9506740966

drshalinimohan@gmail.com 
Dr Sukhada Mishra  J P M Rotary Club of Cuttack Eye Hospital & Research Institute  J P M Rotary Club of Cuttack Eye Hospital & Research Institute, CDA, Sector-VI, Markat Nagar, Cuttack-753014, Odisha, India.
Cuttack
ORISSA 
9437164357

debasukhada@rediffmail.com 
Dr Vupputuri Venkata Lakshmi Narasimha Rao  King George Hospital  Govt. Regional Eye Hospital,Opp Bullayya College, Resapuvanipalem, Andhra Medical College, Visakhapatnam-530013, India
Visakhapatnam
ANDHRA PRADESH 
9885268979

drvvlclinicalresearch@gmail.com 
Dr Sandeep Saxena  King Georges Medical University  Dept.of Ophthalmology,King Georgs Medical University, Shahmina Road, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH 
9415160528

sandeepsaxena2020@yahoo.com 
Dr Srikant Kumar Sahu  L V Prasad Eye Institute  LV Prasad Eye Institute, MTC Campus, Patia, Bhubaneshwar-751024 Odisha
Khordha
ORISSA 
9439488888

srikantsahu@lvpei.org 
Dr Sudhir Kumar Garg  Maharaja Agrasen Horpital  Maharaja Agresen Hospital, Punjabi Bagh, New Delhi-110026
New Delhi
DELHI 
91981141119

drskgi2610@gmail.com 
Dr Daxa Pande  Medilink Hospital Research Centre  Basement Medilink Hospital, Shyamal Cross Road, 132, ft. Ring Road, Satellite, Ahmedabad-380015
Ahmadabad
GUJARAT 
08347457660

daxajay_108@yahoo.com 
Dr A Tarakeswara Roa  Rajiv Ganddhi Institute of Medical Sciences & RIMS  Dept. of Ophthalmology, Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital, Srikakulam-532001, Andhra Pradesh
Srikakulam
ANDHRA PRADESH 
918942279033

drtarakrims@gmail.com 
Dr Kumudini Sharma  Sanjay Gandhi Postgraduate Institute of Medical Sciences  Dept. Of Ophthalmology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknmow-226014, India.
Lucknow
UTTAR PRADESH 
8004904441

kumud@sgpgi.ac.in 
Dr Jigeesh Nareshbhai Desai   Sanjivani Superspeciality Hospital Pvt Ltd.  Sanjivani Superspeciality Hospital Pvt Ltd, 1, New Uday Society, Nr. Sunrise Park, Vastrapur, Ahmedabad-380015
Ahmadabad
GUJARAT 
9426001724

dr.jigeeshdesai@gmail.com 
Dr Aniruddha Maiti  Susrat Eye Foundation & Research Centre  Susrat Eye Foundation & Research Centre, HB-36/A/1, Sector III, Salt Lake City, Kolkata-106
Kolkata
WEST BENGAL 
9836552140

write2maiti@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 18  
Name of Committee  Approval Status 
Arnejas Institutional Ethics Committee  Approved 
Bioethics Cell Institutional Ethics Committee  Submittted/Under Review 
Chandulal Chandrakar Memorial Medical College and Hospital Institutional Ethics Committee  Approved 
Ethics Committee GSVM Medical College  Approved 
Ethics Committee LV Prasad Eye Institute Patia  Submittted/Under Review 
Ethics Committee Rajiv Gandhi Institute of Medical Sciences & RIMS Govt General Hospital  Approved 
Ethics Committee, Institute of Medical Sciences (lMS) and SUM Hospital  Submittted/Under Review 
IEC for KGMU  Submittted/Under Review 
Institutional Ethics Committee B.J. Medical College & Civil Hospital  Approved 
Institutional Ethics Committee Bansal Hospital & Research Centre  Approved 
Institutional Ethics Committee Gandhi Medical College  Approved 
Institutional Ethics Committee GCS Medical College, Hospital and Research Centre  Approved 
Institutional Ethics Committee JPM Rotary Club of Cuttack Eye Hospital & Research Institute  Approved 
Institutional Ethics Committee Kings George Hospital  Submittted/Under Review 
Institutional Ethics Committee Maharaja Agresen Hospital  Submittted/Under Review 
Institutional Ethics Committee Susrut Eye Foundation & Research Centre  Submittted/Under Review 
Medilink Hospital Ethics Committee  Approved 
Sanjivani Hospital Ethics Committee  Submittted/Under Review 
 
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 
Intervention  Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops   Instil one drop in each affected eye once a day for 28 days. 
Comparator Agent  Alcaftadine Ophthalmic Solution 0.25% w/v   Instil one drop in each affected eye once a day for 28 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female subjects, aged 18 years to 65 years (both inclusive).
2.Treatment naïve subjects with diagnosis of ocular itching associated with allergic conjunctivitis (primary outcome measure).
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 Giant Papillary Conjunctivitis (GPC) will be excluded from the study.
2.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
3.Subjects with presence of ocular infection (bacterial, viral or fungal) or history of ocular herpes within 3 months of screening visit.
4.Subjects with chronic ocular degenerative condition or active intraocular inflammation that could worsen during the study.
5.Subjects with known case of persistent dry eye syndrome or currently on treatment for dry eyes.
6.Subjects with known case of corneal epithelial detachment, corneal ulcer, Keratitis and evidence of corneal epithelial breakdown etc.
7.Subjects with known case of glaucoma will be excluded from the study.
8.Subjects with known case of ocular surgery within 6 months or scheduled to undergo ocular surgery during the study period.
9.Subjects planned to use contact lenses in the study eye during the study period.
10.Subjects with Visual acuity of 20/80 in any eye.
11.Subjects with Type 1 diabetes or Type 2 diabetes mellitus with HbA1c value greater than 8% within last 3 month prior to screening will be excluded from the study.
12.Subjects with known case of diabetic retinopathy.
13.Subjects with known case of clinically significant trauma to the study eye within the past 12 months.
14.Subjects who are blind or subjects with single eye will be excluded from the study.
15.Subjects with active peptic ulcer disease, gastrointestinal bleeding or perforation, or known history of peptic ulcer disease or gastrointestinal bleeding or any other bleeding disorders.
16.Clinically relevant recent (within 6 months of baseline visit) history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of the Investigational product.
17.Subjects with 1 month prior to screening visit or current use of systemic, topical or ocular corticosteroids, NSAIDs, anticholinergics, immunosuppressants, or H1-antihistamines.
18.Any contraindications or hypersensitivities to the use of the study medication or their components.
19.History of alcohol abuse and smoking.
20.Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
21.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
22.Suspected inability or unwillingness to comply with the study procedures.
 
 
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 in ocular itching score from baseline at all visits after randomization  At the end of Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Change in conjunctival hyperemia grade from baseline at all visits after randomization.
Change in Tearing score from baseline at all visits after randomization.
Change in Chemosis score from baseline at all visits after randomization.
Assessment of study medications by Subjects and Investigators at end of study visit.
 
At the end of Day 28 
 
Target Sample Size   Total Sample Size="236"
Sample Size from India="236" 
Final Enrollment numbers achieved (Total)= "222"
Final Enrollment numbers achieved (India)="222" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/09/2018 
Date of Study Completion (India) 23/02/2019 
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   Yet Not 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is A Phase III, Multicenter, Comparative, Randomized, Double blind, Two arm, Parallel group Clinical Study to evaluate Efficacy and Safety of Fixed  dose combination of Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops compared with Alcaftadine Ophthalmic Solution 0.25% w/v for the treatment of Subjects with Ocular Itching associated with Allergic Conjunctivitis.

Primary Objective: To evaluate the efficacy of fixed dose combination of Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops compared with Alcaftadine Ophthalmic Solution 0.25% w/v for the treatment of Subjects with Ocular Itching associated with Allergic Conjunctivitis.

Secondary Objective: To evaluate the safety of fixed dose combination of Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops compared with Alcaftadine Ophthalmic Solution 0.25% w/v for the treatment of Subjects with Ocular Itching associated with Allergic Conjunctivitis.  

 
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