| CTRI Number |
CTRI/2015/11/006338 [Registered on: 02/11/2015] 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 test the Effectiveness, Safety and Tolerance of Alcaftadine eye drops in comparison with Olopatadine hydrochloride eye drops in patients who are suffering from Allergic Conjunctivitis |
|
Scientific Title of Study
|
A Clinical Trial to Study the Efficacy, Safety and Tolerability of Alcaftadine eye drops Vs. Olopatadine hydrochloride eye drops in Subjects Suffering from Allergic Conjunctivitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/12/02; Version No.: 4.0, Dated 03.02.2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Kempegowda Institute of Medical Sciences |
| Address |
Kempegowda Institute of Medical Sciences
B Block,
OPD Building Ground Floor,
Department of Ophthalmology,
VV Puram,
KR Road,
Bangalore–560004.
Karnataka.
Bangalore
KARNATAKA
560004
India |
| Phone |
91-9916103274 |
| Fax |
|
| Email |
drkirankumar06@gmail.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
400067
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
400067
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-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 = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Ambade |
Arneja Heart & Multispecialty Hospital |
Room No.5, Ground Floor, Ophthalmology Department, Arneja Heart & MultiSpecialty Hospital, 123, Ramdaspeth, Nagpur 440010, Maharashtra.
Nagpur
MAHARASHTRA |
09823178466
drajaya.cicrs@gmail.com |
| Dr Mohua Mazumdar |
Institute of Post Graduate Medical Education & Research |
Department of Ophthalmolgy, Institute of Post Graduate Medical Education & Research, 244, AJC Bose Road, Kolkata-700020, West Bengal, India
Kolkata
WEST BENGAL |
9830682007
mazumder_mahua@yahoo.com |
| Dr Kiran Kumar |
Kempegowda Institute of Medical Sciences |
Kempegowda Institute of Medical Sciences
B Block,
OPD Building,
Ground Floor,
Department of Ophthalmology Kempegowda Institute of Medical Science,
VV Puram,
KR Road,
Bangalore–560004
Bangalore
KARNATAKA |
91-9916103274
drkirankumar06@gmail.com |
| Dr Sanjeev Kumar Gupta |
King George’s Medical University |
Room no. 208, First Floor, Department of Ophthalmology,
King Georges Medical University, Chowk, Lucknow – 226003, Uttar Pradesh, India.
Lucknow
UTTAR PRADESH |
9532998211
sanjiv204@gmail.com |
| Dr Dhas Sachin Dnyaneshwar |
Lifepoint Multispecialty Hospital |
Room No. 104, Ophthalmology Department, First Floor,
Lifepoint Multispeciality Hospital, 145-1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune-411057, Maharashtra, India
Pune
MAHARASHTRA |
9881310464
drsachindhas@gmail.com |
| 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 Tamal Roy |
Regional Institute of Ophthalmology |
Department of Ophthalmology
Medical College,
88,
College Street,
Kolkata-700073.
Kolkata
WEST BENGAL |
91-9051831597
tamal_oph@yahoo.com |
| Dr Saroj Sahdev |
Seth G.S. Medical College & K.E.M Hospital |
Dept. of Ophthalmology,
Seth G.S. Medical College & K.E.M Hospital,
Parel,
Mumbai-400012
Mumbai
MAHARASHTRA |
91-9820512629
sisahdev@hotmail.com |
| 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= 9 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Arnejas Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, Kempegowda Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, King George’s Medical University U.P. |
Approved |
| Institutional ethics Committee, Lifepoint Research - Ethics Committee |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Goverment General Hospital |
Approved |
| Institutional Ethics Committee, Regional Institute of Ophthalmology |
Submittted/Under Review |
| Institutional Ethics Committee, Seth G.S Medical College & KEM Hospital |
Submittted/Under Review |
| IPGME&R Research Oversight Committee |
Approved |
| 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 |
Subjects suffering from Allergic Conjunctivitis, (1) ICD-10 Condition: H119||Unspecified disorder of conjunctiva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alcaftadine 0.25% w/v Eye Drops |
Instill one drop in each eye once daily for 14 days. |
| Comparator Agent |
Olopatadine hydrochloride 0.2% w/v Eye Drops |
Instill one drop in each eye once daily for 14 days |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The study will be conducted in 2 stages:
In 1st stage subjects between 18 to 60 years (both inclusive) will be enrolled. Based on the outcome of 1st stage of the study and its report submitted to the committee, in the 2nd stage, study will be conducted on 10 to less than 18 years age group of subjects.
2. Subjects with diagnosis of allergic conjunctivitis.
3. Freshly diagnosed or subject who are previously diagnosed and on treatment of Allergic conjunctivitis will undergo washout period for 3 days.
4. Voluntary willingness of patient to give written as well as Audio-Visual informed consent prior to participation in clinical trial. For Minor subject LAR (Legally Acceptable Representative) should be taken with assent form.
|
|
| ExclusionCriteria |
| Details |
1. Male and female subjects <10 years and >60 years of age.
2. Women who were not using an effective means of contraception or who are pregnant or nursing.
3. Visual acuity of 20/40 in any eye.
4. Subject who are blind or subject with single eye.
5. Subject with history of active stage of any other concomitant ocular disease.
6. Contraindication or sensitivity to any component of study treatment.
7. Subject having history of chronic use of ocular medication other than the study drug, progressive or functionally visual field loss within the past year.
8. Contact lens user.
9. Subject who are schedule to undergo surgery of the eye during the study period.
10. Subject with known history of ocular inflammation or any other condition that in the opinion of the investigator that does not justify the patient’s participation in the study.
11. Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
12. Subject not willing to comply with the study protocol and provide written informed consent to participation.
13. Any disease or condition that could interfere with the safety and efficacy evaluation of the study medication.
14. Have used H1-antagonist antihistamines within 72 hours.
15. 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.
16. Subject with Schirmer<10 should be excluded from the study. |
|
|
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 Alcaftadine Vs. Olopatadine hydrochloride eye drops in Subjects Suffering from Allergic Conjunctivitis. |
Day 0, At the end of 3rd Day, At the end of 7th Day, At the end of 14th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety and tolerability of Alcaftadine Vs. Olopatadine hydrochloride eye drops.
Global assessment of study medications by Subjects and Investigators. |
Day 0, At the end of 3rd Day, At the end of 7th Day, At the end of 14th Day
Global assessment of study medications by Subjects and Investigators at the end of 14th Day |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="204" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/11/2015 |
| Date of Study Completion (India) |
25/05/2016 |
| 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 Alcaftadine eye drops or Olopatadine
hydrochloride eye drops 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 and conjuctival redness. |