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
|
|
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
|
|
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. |