| CTRI Number |
CTRI/2013/10/004114 [Registered on: 30/10/2013] Trial Registered Prospectively |
| Last Modified On: |
05/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of SPILs Loteprednol with reference Lotemax |
|
Scientific Title of Study
|
Aqueous Humor Bioequivalence Study of Loteprednol 0.5 %, Sun Pharmaceutical Industries Ltd (SPIL) and Lotemax in Patients Undergoing Cataract Surgery: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Cross over, Active Controlled Study |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CLR_11_07 Version 06, 26 Sep 2014 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Ltd. |
| Address |
Sun Pharma Advanced Research Company Ltd.
17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Sun Pharma Advanced Company Research Ltd |
| Address |
Sun Pharma Advanced Research Company Ltd, 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai India
Mumbai
MAHARASHTRA
400093
India |
| Phone |
912266455645 |
| Fax |
91226645685 |
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Sun Pharma Advanced Company Research Ltd |
| Address |
Sun Pharma Advanced Research Company Ltd, 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai India
Mumbai
MAHARASHTRA
400093
India |
| Phone |
912266455645 |
| Fax |
91226645685 |
| Email |
clinical.trials@sparcmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Advanced Research Company Ltd 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400093, India |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Advanced Research Company Ltd |
| Address |
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400093, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Purvi Bhagat |
Glaucoma Clinic, M and J institute of ophthalmology, Civil Hospital |
Room no. 3, Ground floor, M and J Institute of ophthalmology,Civil hospital, Asarwa, Ahmedabad - 380 016.
Ahmadabad
GUJARAT |
9376271000
rupal@newvisionindia.com |
| Dr kalyani VKS |
PBMA’s H. V. Desai Eye Hospital |
93/2, Main OPD, Ground Floor, Main Building, PBMAs H.V.Desai Hospital, Tarwadewasti, Mohammadwadi, Hadapsar, Pune-411028.
Pune
MAHARASHTRA |
9423001834
02026970087
drkalyanimark@yahoo.co.in |
| Dr Rupal Shah |
Shree Hi-Tech Clinic Pvt. Ltd |
No. 229, Second floor, Siddharth complex, R C Dutt Road, Alkapuri, Vadodara - 390 007; Tel: 0265 3058610/611
Ahmadabad
GUJARAT |
9376271000
rupal@newvisionindia.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee of Centre for Knee Surgery/Dr. Rupal Shah/Vadodara |
Approved |
| Institutional Ethics Committee, PBMAs H.V. Desai Eye Hospital/ Dr. Kalyani VKS/pune |
Approved |
| The Institutional Ethics Committee, B.J. Medical College & Civil Hospital/Dr. Purvi Bhagat/Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
cataract extraction, (1) ICD-10 Condition: H268||Other specified cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator reference drug |
Topical ocular single dose administration |
| Intervention |
SPILs Loteprednol |
Topical ocular single dose administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Men or women ≥18 years of age (no upper age limit mentioned in the protocol)
-Willing to give informed consent
-elected for cataract extraction |
|
| ExclusionCriteria |
| Details |
-history of hypersensitivity to any of the components used in the preparation of the study drug
-History of chronic or recurrent severe inflammatory eye disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetic assessment |
Pre-dose, 30 min, 60 min, 90 min, 120 min, 240 min and 360 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety |
Visit 2 to Visit 6 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
10/04/2014 |
| 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
Modification(s)
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted to assess bioequivalence of SPIL’s
loteprednol ophthalmic suspension to the reference listed drug in patients undergoing
cataract surgery and to monitor the safety of the patients participating in the
study.
|