Srishti Complex, Sector 1, Bhaktivedanta Swami Marg, Mira Road East, Thane, Maharashtra 401107, India.
Mumbai MAHARASHTRA
9833547425
drsuraj.b@bhaktivedantahospital.com
Dr Prashanth C N
Dr. B. R. Ambedkar Medical College
Room No. 03, 2nd Floor, Ophthalmology Department,
New OPD building, Dr.B.R. Ambedkar Medical College and Hospital, Shampura Main Road, K.G.Halli, Bangalore-560045 Bangalore KARNATAKA
9880708204
prashanthcndoctor@gmail.com
Dr Shalini Mohan
G.S.V.M Medical College
Department of Opthalmology,Ward no : 08 LLR Hospital,
Swaroop Nagar, Kanpur-208005 (U.P.)
Kanpur Nagar UTTAR PRADESH
9506740966
drshalinimohan.research@gmail.com
Dr Hemaxi Desai
GCS Medical College, Hospital & Research Centre
Department of ophthalmology, Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad - 380 025, Gujarat, India
Ahmadabad GUJARAT
9898065645
hemaxi.patel@gcsmc.org
Dr Rekha Mudhol
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
SMO office, Second Floor, Near psycharty ward, Nehru Nagar, Belagavi.590010 Belgaum KARNATAKA
9449938997
rekhamudhol@gmail.com
Dr Smita Sapate
Mahatme Eye Bank & Eye Hospital
2163/C Chintaman Nagar, Somalwada, Nagpur-440015, Maharashtra , India. Nagpur MAHARASHTRA
09922924637
drsmitaPsapate@gmail.com
Dr Abhijeet Deshpande
Meditrina Institute of Medical Sciences
278,Central Bazar Road,Ramdaspeth,NAGPUR - 440 012, Maharashtra , India. Nagpur MAHARASHTRA
9422105512
abhidesh123@reddifmail.com
Dr S Gopinath
Mysore Medical College and Research Institute and Associated Hospitals
Irwin Road, Mysore, Karnataka 570021, India. Mysore KARNATAKA
9448101419
gsgopinath61@gmail.com
Dr Rupal Shah
New Vision Laser Center Pvt. Ltd.
101, Tower A,Atlantis K-10, First Floor, Atlantis, Sarabhai Compound, Opp Honest Restaurant, Near Genda Circle, Vikram Sarabhai Road, Vadodara 390007, Gujarat, India. Vadodara GUJARAT
9376271000
rupal@newvisionindia.com
Dr Rekha Khandelwal
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Dept of Opthalmology, Digdoh Hills,Hingna, Nagpur, 440019, Maharashtra Nagpur MAHARASHTRA
9823515550
anand.rathi07@gmail.com
Dr Kalyani VKS
PBMAs H. V. Desai Eye Hospital
Room No 202., Second Floor, Dharmacy Nesay Superspecality Building, S.No 93, Tarawade Vasri, Mohammadwadi Road, Hadapsar, Pune 411060 Pune MAHARASHTRA
9423001834
drkalyanimark@yahoo.co.in
Dr R R Sudhir
Sankara Nethralaya, Medical & Vision Research Foundation
New No.41 ( Old No.18),C.U.Shah Cornea Services A SIVASAILAM BLOCK
No. 21, Pycrofts Garden Road (off. Haddows Road,
Nungambakkam,
Chennai 600 006.
Tamil Nadu, India Chennai TAMIL NADU
9444174847
rrsudhir@Yahoo.com
Dr Ashwini
Sapthagiri Institute of Medical Sciences and Research Centre
Room no:02, First floor, Ophthalmology dept , No. 15, Chikkasandara, Hessarghatta main Road, Bangalore-560090 Bangalore KARNATAKA
9731799114
ashwini_kulenur@yahoo.com
Dr Sheela Kerkar
Seth G. S. Medical College & KEM Hospital
OPD No.36,Department of Ophthalmology, Seth G.S. Medical College & KEM Hospital, Old Building, Ground Floor, Acharya Donde Marg, Parel, Mumbai. – 400012. Mumbai MAHARASHTRA
9820297576
mshah@parshwalifescieces.in
Dr Anupama Vyas
Shalby Hospitals
9th Floor, Clinical research department, Shalby Hospitals, Opposite Karnavati Club, S.G.Highway, Ahmedabad – 380015, Gujarat, India. Ahmadabad GUJARAT
9714821300
anupama.vyas@shalby.org
Dr Tinku Bali Razdan
Sir Ganga Ram Hospital
Rajinder Nagar,
New Delhi -110060,
India. New Delhi DELHI
Reference product1506 manufactured by Bausch & Lomb, Inc.It is 0.5% ophthalmic suspension of loteprednol etabonate
Intervention
SPIL1506 Ophthalmic suspension
SPIL1506 manufactured by Sun Pharmaceutical Industries Limited,India
Inclusion Criteria
Age From
18.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
1.Willing and able to provide written informed consent prior to any study procedures being performed.
2. Ready and able to follow all instructions and attend all study visits.
3.Have planned bilateral cataract extraction
4. Agree to perform pregnancy test before participation in the trial
5.Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential.
ExclusionCriteria
Details
1.Have any active ocular disease in either eye that requires prescription treatment
2.Have an active infection (bacterial, viral or fungal) of either eye or eyelids
3.Pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test.
4.use of an investigational drug or device within 30 days of Visit 1.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1.Pharmacokinetic parameter :(AUC0-6) and Cmax
1.Pharmacokinetic parameter : over a period of approximately 7 to 63 days
Secondary Outcome
Outcome
TimePoints
None
Not Applicable
Target Sample Size
Total Sample Size="418" Sample Size from India="418" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
01/09/2017
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
None yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?