| CTRI Number |
CTRI/2015/05/005783 [Registered on: 19/05/2015] 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 evaluate Efficacy, Safety and Tolerability of 2% Rebamipide ophthalmic suspension Vs 0.1 % Sodium Hyaluronate Ophthalmic solution for treatment of patients with Dry Eye |
|
Scientific Title of Study
|
A Multicentric, Double Blind, Randomized, Active Control, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of 2% Rebamipide Ophthalmic Suspension Vs. 0.1 % Sodium Hyaluronate Ophthalmic solution for treatment of patients with Dry Eye. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/13/02,Version No 1.0,Dated 24 June 2014 |
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
400067
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
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 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 = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwini Sapre |
GMERS Medical College & General Hospital |
Gotri Road,
Vadodara-390021.
Gujarat.
Vadodara
GUJARAT |
9825625516
ashwinisapre@yahoo.com |
| Dr A Tarakeswara Rao |
Government Regional Eye Hospital |
Resapuvanipalem
Visakhapatnam-530013
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH |
9441873644
tarakeye@gmail.com |
| Dr Pradeep Saraf |
Health point Hospital |
Health point Hospital,multi-Speciality ,21 prannathpandit street,Kolkata
Kolkata
WEST BENGAL |
8420011311
pksaraf@myeyeworld.com |
| Dr Pramod Kumar |
King George’s Medical University |
Department of
Ophthalmology,
South Wing, 1st
Floor, King George
Medical University
Chowk, Lucknow-
226003
Lucknow
UTTAR PRADESH |
9838894091
Pramodkumar2020@rediffmail.com |
| Dr Shweta Bhide |
Muktai Hospital |
Plot no 11
Shivaji Nagar
Opp Fame Adlabs
Nashik Pune Road Nashik 422006
Maharashtra
Nashik
MAHARASHTRA |
9371103254
shwetabhidensk@gmail.com |
| Dr V Dinesh Kanth |
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital |
Srikakulam-532001
Andhra Pradesh
Srikakulam
ANDHRA PRADESH |
8500949101
dkmedico17@gmail.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 |
09820512629
sisahdev@hotmail.com |
| Dr Ashok Grover |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital
Rajendra Nagar
Pvt O.P.D Room No -F1 New Delhi- 110060
North West
DELHI |
91-9811083026
Akgrover55@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Health Point Ethics Committee |
Approved |
| Institutional Ethics Committee Seth GS Medical College & KEM Hospital |
Approved |
| Institutional ethics committee GMER Medical College |
Approved |
| Institutional Ethics Committee- King Geoge’s Medical University |
Approved |
| Institutional Ethics Committee_KGMU |
Approved |
| Institutional Ethics Committee_RIMS Govt. General Hospital |
Approved |
| Muktai Hospital Ethics Committee |
Approved |
| Sir Ganga Ram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
For the treatment of Dry Eye signs and symptoms., (1) ICD-10 Condition: H041||Other disorders of lacrimal gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.1 % Sodium Hyaluronate |
1 drop in affected eye(s) Four times daily for 24 weeks |
| Intervention |
2% Rebamipide ophthalmic suspension |
1 drop in affected eye(s) Four times daily for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.A clinical diagnosis Dry Eye at least since from 20 months.
2.Anesthetized Schirmer test score of 0 to 9 mm per 5minutes or less or tear breakup time is 5 seconds or less.
3.Best corrected visual acuity of 0.2 or better in both eyes.
4.Voluntary willingness to give written informed consent prior to participation in trial.
5.Wash out period for subjects who are on medications for same condition will be 3 days. |
|
| ExclusionCriteria |
| Details |
1.Any active inflammation of eyes.
2.Any long lasting inflammation of eyes.
3.Subject with block nasal duct.
4.Subjects with history of recurrent corneal erosions diagnosed by slit lamp examination.
5.Subjects with history of epithelial basement membrane dystrophy.
6.Subjects with history of floppy eyelid syndrome diagnosed by Slit lamp examination
7.Subjects with history of Conjunctivochalasis diagnosed by slit lamp examination
8.Anterior segment disease like Glaucoma or Ocular Hypertension.
9.Using Cyclosporine since long time
10.Use of contact lenses
11.Use of topically instilled Ocular medication during study.
12.History of Ocular surgery within 12 months.
13.Females who are pregnant, lactating, or child bearing potential.
14.Females who are not willing to remain abstinent or use contraception.
15.Subjects who are on systemic Hormonal or corticosteroid therapy.
16.Subjects with history of Diabetes Mellitus.
17.Presence of Stevens Johnson Syndrome.
18.Ocular surgery due to Dry eye Syndrome.
19.Use of topical &/or systemic treatment potentially interfering with tear production.
20.Concurrent involvement in another study or previous receipt of same drug.
21.Any ocular condition that, in the opinion of the investigator, could affect the subject’s safety or trial parameters.
22.Known contraindications or sensitivities to the study medication or its components.
23.Other patients who are 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 determine Efficacy of 2% Rebamipide Ophthalmic Suspension compared to 0.1% Sodium Hyaluronate for the treatment of patients with Dry eye. |
Day1, 4th week, 8th week, 12thweek, 16th week, 20thweek, 24thweek |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To determine Safety and Tolerability of 2% Rebamipide Ophthalmic Suspension Compared to 0.1% Sodium Hyaluronate in patients with Dry eye
•Global assessment of study medication by Investigators and Patients
|
Day1, 4th week, 8th week, 12thweek, 16th week, 20thweek, 24thweek |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/06/2015 |
| 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="6"
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
|
A Multicentric, Double Blind, Randomized, Active Control, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of 2% Rebamipide Ophthalmic Suspension Vs. 0.1 % Sodium Hyaluronate Ophthalmic solution for treatment of patients with Dry Eye.
Dry eye is a condition characterized by a patient’s inability to produce enough tears or the appropriate quality of tears to keep the eye healthy and comfortable.
The primary end point will be assessed by the change in Fluorescein Corneal Staining (FCS) Score at every visit for 24 weeks of treatment.
The secondary end points are Foreign Body Sensation, Dryness, Photophobia, Eye Pain and blurred vision will be assessed. |