| CTRI Number |
CTRI/2021/11/037890 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
29/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate efficacy and safety of Tropicamide, Phenylephrine, Lidocaine intracameral injection in patients
undergoing cataract surgery. |
|
Scientific Title of Study
|
An Open label, single arm, multi centre, Phase IV clinical study to evaluate efficacy and safety of Tropicamide
0.2mg/ml, Phenylephrine HCl 3.1mg/ml, Lidocaine HCl 10mg/ml intracameral injection in patients
undergoing cataract surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT- CE-CS- 2020,Ver 2.0,dated 17May2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trial Operations |
| Affiliation |
CliniExperts Research Services Private Limited |
| Address |
Unit No. 325, City Center Mall, Plot no. 5, Sector 12, Dwarka
New Delhi
DELHI
110075
India
Unit No. 325, City Center Mall, Plot no. 5, Sector 12, Dwarka
New Delhi
DELHI
110075
India
New Delhi
DELHI
110075
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@cliniexperts.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trial Operations |
| Affiliation |
CliniExperts Research Services Private Limited |
| Address |
Unit No. 325, City Center Mall, Plot no. 5, Sector 12, Dwarka
New Delhi
DELHI
110075
India
Unit No. 325, City Center Mall, Plot no. 5, Sector 12, Dwarka
New Delhi
DELHI
110075
India
New Delhi
DELHI
110075
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@cliniexperts.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trial Operations |
| Affiliation |
CliniExperts Research Services Private Limited |
| Address |
Unit No. 325, City Center Mall, Plot no. 5, Sector 12, Dwarka
New Delhi
DELHI
110075
India
Unit No. 325, City Center Mall, Plot no. 5, Sector 12, Dwarka
New Delhi
DELHI
110075
India
New Delhi
DELHI
110075
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@cliniexperts.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sunways India Pvt Ltd |
| Address |
1002-1003, 10th Floor, Windfall,
Sahar Plaza, J.B.Nagar,
Andheri-Kurla Road, Andheri (East),
Mumbai-400059. Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atanu Biswas |
college of medicine & JNM Hospital |
College of Medicine &JNM Hospital Kalyani, West Bengal 741235
Kolkata
WEST BENGAL |
8373095828
dratanubiswas@gmail.com |
| Dr Virendra Agarwal |
Dr. Virendra Phaco Surgery Centre |
SP Rd, behind Toyota Car Showroom, Gautam Nagar, Gandhi Nagar, Jaipur, Rajasthan 302015
Jaipur
RAJASTHAN |
9314017147
virendravlpsc1@gmail.com |
| Dr Rakesh Porwal |
JLN Medical College and attached Hospitals, |
Kala Bagh, Ajmer – 305001, Rajasthan, India
Ajmer
RAJASTHAN |
9414004414
dr.rakeshporwal@gmail.com |
| Dr Pramod Kumar |
King George’s Medical University |
Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003-India
Lucknow
UTTAR PRADESH |
9838894091
pramodkumar2020@rediffmail.com |
| Dr Pooja Bhomaj |
Shanti Saroj Netralay |
A.N.Gaikwad, 901/902, Beside Sundar Nagar, Anand Nursing home road, off, Sangli - Miraj Rd, Miraj, Maharashtra 416410
Mumbai
MAHARASHTRA |
9890644489
drpoojabhomaj@gmail.com |
| Dr Sharath Shetty |
Vagus Super Specialty Hospital, |
6,7 & 8, ,18th Cross,Malleshwaram, Bangalore, Karnataka - 560008
Bangalore
KARNATAKA |
9342054123
shettysharath@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| College of Medicine and JNM Hospital,Kolkata |
Approved |
| Dr. Virendra Laser,Phaco Surgery Centre |
Approved |
| IEC- Mahatma Gandhi Cancer Hospital, Near Gulabrao Patil Homeopathic Medical College Miraj Sangli Maharashtra-416410 India |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College & Attached Hospital, Ajmer |
Approved |
| Institutional Ethics Committee, King Georges Medical University, Lucknow - 226003 |
Approved |
| Vagus Institutional Ethics Committee,Vagus Super Speciality,6,7,8 & 18th cross Malleswaram,Bangalore-560055 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Tropicamide 0.2mg/ml, Phenylephrine HCl 3.1mg/ml, Lidocaine HCl 10mg/ml |
Single dose of study product injected into the anterior chamber of
eye at the beginning of the cataract surgery procedure.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Signed informed consent prior to any study-mandated procedure.
2.Male or female aged 18 years and 65 years (both inclusive).
3.Cataract of any grade and type requiring cataract surgery indiscretion of Study
Investigator.
4.No secondary procedure planned (i.e. trabeculectomy,keratectomy,corneal
transplant,vitreoretinal procedure etc.)
5.Systemic condition capable of undergoing topical anesthesia
6.No previous intraocular surgery |
|
| ExclusionCriteria |
| Details |
1.Any iris pathology including but not limited to posterior synechia,iridocorneal
endothelial syndrome,corectopia,traumatic mydriasis,Horners syndrome,Adies pupil,cyclodialysis,iridodialysis
2.Corneal pathology affecting pupil magnification or measurement (keratoconus,
peripheral thinning,sclerocornea,scarring)
3.Known hypersensitivity to any of the individual formulation of Investigational
product.
4.Uncontrolled Hypertension as judged by investigator
5.Pregnant and/ or Lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pupil size |
Time Frame: At beginning, post Investigational product administration, every 5
minutes till next 30 minutes and completion of cataract surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative pain
2.Assessment of Clinical Global Impression scale change from baseline
3.Clinical Adverse events throughout the study |
1. Time Frame: 1 hour post surgery |
|
|
Target Sample Size
|
Total Sample Size="223"
Sample Size from India="223"
Final Enrollment numbers achieved (Total)= "223"
Final Enrollment numbers achieved (India)="223" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/11/2021 |
| Date of Study Completion (India) |
19/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Data Would Be Published Once Study Is Complete |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an Open-label, single-arm, Phase IV clinical study to evaluate the efficacy and safety of Tropicamide 0.2mg/ml, Phenylephrine HCl 3.1mg/ml, Lidocaine HCl 10mg/ml intracameral injection in patients undergoing cataract surgery.
Cataract surgery, also called lens replacement surgery, is the removal of the natural lens of the eye that has developed an opacification, which is referred to as a cataract, and its replacement with an intraocular lens.
Intracameral (IC) administration of mydriatics is an alternative to the traditional topical regimen for cataract surgery.
|