| CTRI Number |
CTRI/2015/10/006326 [Registered on: 28/10/2015] Trial Registered Prospectively |
| Last Modified On: |
28/10/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A bioequivalance study comparing Tobradex eye drops of Alcon pharma with study medication with same combination of Cipla in aqueous humor of patients undergoing cataract surgery. |
|
Scientific Title of Study
|
A Multi Center, Open Label, Randomized, Two-Treatment, In Vivo, Crossover, Single Dose, Bioequivalence Study with Pharmacokinetic Endpoints to Compare the Pharmacokinetics of Marketed Product TobraDex® (Containing Tobramycin 0.3% and Dexamethasone 0.1 % Ophthalmic Suspension, Manufactured by Alcon Laboratories, Inc., USA.) to an Investigational Ophthalmic Sterile Suspension (Containing Tobramycin 0.3% and Dexamethasone 0.1%, Manufactured by Cipla Limited, India), in Aqueous Humor of Patients Undergoing Indicated Cataract Surgery |
| Trial Acronym |
TBO Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No ,S-14-969 version 1.0 number, Date 17 Nov 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowbhagya H N |
| Designation |
Professor and HOD dept of Ophthalmology |
| Affiliation |
Kempegowda Institute of Medical Sciences |
| Address |
V V Puram, K R Road
Bangalore
KARNATAKA
560004
India |
| Phone |
09620937759 |
| Fax |
|
| Email |
drhnsowbhagyaappaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shylashree Baraskar |
| Designation |
Medical Monitor |
| Affiliation |
Semler Research Center |
| Address |
75A, 15th Cross, I Phase J.P.Nagar,
Bangalore
KARNATAKA
560078
India |
| Phone |
08971336986 |
| Fax |
|
| Email |
drshylb@semlerresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vijay Bhaskar |
| Designation |
Project Manager |
| Affiliation |
Semler Research Center |
| Address |
75A, 15th Cross, I Phase J.P.Nagar
Bangalore
KARNATAKA
560078
India |
| Phone |
09741281900 |
| Fax |
|
| Email |
vijay@semlerresearch.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd., R&D Center, 4th Floor,
North Block, LBS Road, Vikhroli (W),
Mumbai 400 083, India |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
R&D Center, 4th Floor, North Block, LBS Road, Vikhroli (W), Mumbai 400 083, 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 Sowbhagya H N |
Kempe Gowda Institute of Medical Sciences |
Room no: 8, Ophthalmology Department, Ground floor, V. V. Puram, K. R. Road,
Bangalore
KARNATAKA |
09620937759
drhnsowbhagyaappaji@gmail.com |
| Dr Kalpit shah |
M and J Institute of Ophthalmology |
Room no:04,Ophthamology Department, Ground fllor, 4Western Regional Institute ofIndia, Civil Hospital
Ahmadabad
GUJARAT |
09725769355
dr.kps74@gmail.com |
| Dr Neeraj Manchanda |
Sir Ganga Ram Hospital |
Room Number: 74, First floor,Sir Ganga Ram Hospital Marg Old Rajinder Nagar, Rajinder Nagar
New Delhi
DELHI |
09811113404
neerajmanchanda@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, B. J. M and J Institute of Ophthalmology, Medical College & Civil Hospital |
Submittted/Under Review |
| Kempe Gowda Institute of Medical Kempegowda Institute of Medical Sciences- Institutional Ethics .Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bilateral cataracts undergoing indicated cataract surgery , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TobraDex |
Frequency: Single Dose of the test or reference product will be administered at at a designated time pre-operatively in each period
|
| Intervention |
Tobramycin 0.3% and Dexamethasone 0.1% Ophthalmic Suspension |
Single Dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1) Men or non-pregnant women of 18 to 65 years of age
(2)Presence of visually significant cataracts in both eyes as established by the complete ophthalmologic exam which are accounting for a best corrected visual acuity of 20/40 or worse as measured on Snellen chart or with glare
(3) Have a chief complaint consistent with visually significant cataracts such as but not limited to halos and/or glare with vision, difficulty reading, ambulating and or walking
(4) Be medically fit with clinically acceptable laboratory profiles
(5) Be willing to follow the required pre operative directions and post op care and be able to follow the scheduled appointment
(6) Have given the written informed consent for participation in the study |
|
| ExclusionCriteria |
| Details |
(1) Participation in any ophthalmic indicative bioavailability/ bioequivalence/ Pharmacokinetic study or received an ophthalmic indicative investigational drug within a period of three months prior to screening
(2) Pregnant women or lactating mothers or women planning to become pregnant during the study period
(3) Presence or history of epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella of the cornea and conjunctiva
(4) History of “recent (last 15 days)†or “active†viral diseases of the cornea and conjunctiva. Presence of corneal conditions like but not limited to Keratoconus, Fuch’s Dystrophy, S/P PKP, Chronic corneal erosion/ulcers/edema, S/P refractive surgery
(5) Presence or history of uveitis or uveitis within the previous 12 months, or laser-assisted in-situ keratomileusis, photorefractive, keratectomy, radial keratotomy, or similar surgery in the previous three months
(6) Presence of retinal disorders including but not limited to glaucoma, active diabetic retinopathy, wet/ dry macular degeneration, Histoplasmosis and any other retinal disease that would make vision worse than 20/50 best corrected will be excluded
(7) Ocular trauma within past three months of the screening, active external ocular disease, inflammation, or infection (mycobacterial or fungal disease) of the study eye and corneal diseases or disruption
(8) Patients who had received topical and or systemic/ oral steroids including but not limited to dexamethasone or beclomethasone within 7 days of screening
(9) History of any allergies (e.g. asthma, urticaria) including drug allergies that would place the patient at increased risk, as determined by the investigator(s)
(10) Known hypersensitivity or allergy to TobraDex® in combination or its components
(11) History of alcohol, chemical, drug abuse or dependence
(12) Serologic positivity for the Hepatitis B virus (HBsAg) and Human Immunodeficiency Virus (HIV 1 and 2)
(13) Presence of clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine, or nervous system
or psychiatric disease or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the patient at increased risk, as determined by the investigator(s) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The objective of this study is to evaluate the bioequivalence of the test product, Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension with the reference listed drug, TobraDex® ophthalmic suspension in aqueous humor of patients undergoing indicated cataract surgery.
|
Pharmacokinetic (PK) profile of dexamethasone in aqueous humor will be determined and compared after administration of a single dose of each of the two drugs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) To monitor the safety and tolerability of a single dose of the test drug and the reference drug in patients undergoing indicated cataract surgery
(2) Sample size determination for the pivotal study |
throughout the study |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
07/11/2015 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study Title: A Multi Center, Open Label, Randomized, Two-Treatment, In Vivo, Crossover, Single Dose, Bioequivalence Study with Pharmacokinetic Endpoints to Compare the Pharmacokinetics of Marketed Product TobraDex® (Containing Tobramycin 0.3% and Dexamethasone 0.1 % Ophthalmic Suspension, Manufactured by Alcon Laboratories, Inc., USA) to an Investigational Ophthalmic Sterile Suspension (Containing Tobramycin 0.3% and Dexamethasone 0.1%, Manufactured by Cipla Limited, India), in Aqueous Humor of Patients Undergoing Indicated Cataract Surgery.Study population: Patients with bilateral cataract Primary Objective: The objective of this study is to evaluate the bioequivalence of the test product, Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension with the reference listed drug, TobraDex® ophthalmic suspension in aqueous humor of patients undergoing indicated cataract surgery. For this purpose, the pharmacokinetic (PK) profile of dexamethasone in aqueous humor will be determined and compared after administration of a single dose of each of the two drugs. Secondary objectives: 1. To monitor the safety and tolerability of a single dose of the test drug and the reference drug in patients undergoing indicated cataract surgery 2. Sample size determination for the pivotal study 5 Visits: V1: Screening (30 days prior to Day 1) V2: (Day 1): Surgery of first eye V3: (Within day 7): Post-operative follow up visit V4: (Within Day 35 after first eye surgery): Surgery of second eye V5: (Within 7 days after second eye surgery): Follow up visit to assess the second operated eye and safety evaluation of both eyes |