| CTRI Number |
CTRI/2021/04/032545 [Registered on: 05/04/2021] Trial Registered Prospectively |
| Last Modified On: |
06/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effect and safety of Phenocaine Plus Injection in Cataract Surgery. |
|
Scientific Title of Study
|
A Phase IV, Multicentre, Open Label Clinical Study to Evaluate The Safety and Efficacy of Intracameral Phenocaine Plus Injection for Anaesthesia and Mydriasis in Cataract Surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-EPL-001 Version 1.0 dated 04 Jan 2021 |
Protocol Number |
| CT-06-21/2021 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Dinkar Deshpande |
| Designation |
Principal Investigator |
| Affiliation |
PBMA’s H. V. Desai Eye Hospital |
| Address |
PBMA’s H. V. Desai Eye Hospital S. No 93 Tarawade Vasti,
Mohammadwadi Hadapsar, Pune
Pune
MAHARASHTRA
411060
India |
| Phone |
9545830707 |
| Fax |
|
| Email |
rddeshpande71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction, Thane west
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction, Thane west
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Entod Pharmaceuticals Ltd.Ashirwad Building Opp Badi Masjid,
SV Road Bandra West,
Mumbai 400050
Maharashtra
|
|
|
Primary Sponsor
|
| Name |
Entod Pharmaceuticals Ltd |
| Address |
Ashirwad building, Opp. Badi Masjid, S V Road,
Bandra (W) Mumbai 400050, Maharashtra, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavita Rao |
Aditya Jyot Eye Hospital |
Plot no. 153, road no. 9, Major Parmeshwaran Road, opp. S.I.W.S. College gate no. 3, Wadala, Mumbai-400031, Maharashtra, India
Mumbai
MAHARASHTRA |
9769935180
drkavitarao@gmail.com |
| DrSatish Shitole |
B.J. Govt. Medical College and Sassoon General Hospital |
Department of Ophthalmology
B.J. G. M. College and Sassoon General Hospital Sassoon Road Station Road Pune Pune Maharashtra - 411001 India
Pune
MAHARASHTRA |
9819812654
drsatish.shitole@gmail.com |
| Dr Namrata Sharma |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences |
Room No 481, 4th Floor ,All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
New Delhi – 110029 (India)
New Delhi
DELHI |
9810856988
namrata.sharma@gmail.com |
| Dr Perwez Khan |
G.S.V.M. Medical College, Kanpur |
Department of Ophthalmology
GSVM Medical College, Swaroop Nagar
Kanpur U.P.,India 208002
Kanpur Nagar
UTTAR PRADESH |
9451875355
drperwezkhan.research@gmail.com |
| Dr Lolly Pattnaik |
Institute of Medical Sciences and SUM hospital |
Department of Ophthalmology
K-8, Kalinga Nagar Bhubaneswar, Odisha-751003, India
Khordha
ORISSA |
6742354333
lollypatnaik@gmail.com |
| Dr Ketaki Jatin Shah |
JMF’s ACPM Medical college & Hospital |
Department of Ophthalmology, JMF’s ACPM Medical college & Hospital, Morane, Sakri Road
Dhule–424001, Maharashtra, India
Dhule
MAHARASHTRA |
7020450433
doctorketaki@gmail.com |
| Dr D N Prakash |
KR Hospital,Mysore Medical College and Research Institute |
Department of ophthalmology Mysore Medical College and Research Institute,KR Hospital.
Irwin
Road Mysuru (Mysore) Karnataka - 570001
Mysore
KARNATAKA |
9342184581
bhanup7@yahoo.com |
| Dr Renu Shukla |
Malla Reddy Hospital |
Department of Ophthalmology, Suraram X Roads, Jeedimetla, Quthbullapur,
Hyderabad, Telangana, PIN-500055
Hyderabad
TELANGANA |
9985031111
drrenushukla@gmail.com |
| Dr Abhijeet Deshpande |
Meditrina Institute of Medical Sciences |
Department of Ophthalmology Meditrina Institute of Medical Sciences,
278, Central Bazar Road, Ramdaspeth, Nagpur, Maharashtra 440012
Nagpur
MAHARASHTRA |
9422105512
abhidesh123@rediffmail.com |
| Dr Kalishankar Das |
N. R. S. Medical College & Hospital |
Department of Ophthalmology,N. R. S. Medical College & Hospital, 138, AJC Bose Road, Sealdah, Kolkata-700014, West Bengal
Kolkata
WEST BENGAL |
9433130189
docksdas@gmail.com |
| Dr Rahul Deshpande |
PBMA’ S H. V. Desai Eye Hospital |
S.No 93, Tarawade Vasti, Mohammadwadi, Hadapsar,
Pune -411060, Maharashtra India
Pune
MAHARASHTRA |
9545830707
rddeshpande71@gmail.com |
| Dr Rachapalle Reddi Sudhir |
Sankara Nethralaya A unit of Medical Research Foundation |
Dept of Preventive Ophthalmology
41/18, College Road, Nungambakkam,
Chennai-600006,
Tamil Nadu, India
Chennai
TAMIL NADU |
9444174847
rrsudhir@yahoo.com |
| Dr Dheeraj Gupta |
W Pratiksha Hospital |
Department of Ophtalmology
Golf Course
Ext. Road, Sushant Lok-ll Sector-56, Gurugram,
Haryana-122011 Gurgaon, India
Gurgaon
HARYANA |
9350600354
drdheeraj@yahoo.com |
| Dr Chandrashekhar M Wavikar |
Wavikar Eye Institute, |
Level 4 and 5, Amber Arcade, Bhiwandi bypass road, Majiwada, Thane-400601, Maharashtra, India
Thane
MAHARASHTRA |
7738097716
drcmwavikar@wavikareye.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Aditya Jyot Eye Hospital Ethics Committee |
Submittted/Under Review |
| Ethics Committee GSVM Medical College |
Approved |
| IEC IMS and SUM Hospital |
Approved |
| IEC of B.J .G.M. C And Sassoon General Hospital |
Submittted/Under Review |
| IEC-MMC and RI and Associated Hospital |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics committee JMFs ACPM Medical College and Hospital |
Approved |
| Institutional Ethics committee Meditrina Institute of Medical sciences |
Submittted/Under Review |
| Institutional Ethics Committee MRIMS |
Approved |
| Institutional Ethics committee NRS Medical college and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee PBMAs H. V. Desai Eye Hospital H. V. Desai Eye Hospital |
Submittted/Under Review |
| North East Heatlthcare Private Limited |
Approved |
| The Institutional Ethics Committee of Vision Research Foundation |
Submittted/Under Review |
| V-Care Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H28||Cataract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Phenocaine Plus Injection |
Prior to the cataract surgery, One single injection of 0.2 ml of Phenocaine plus Injection is slowly injected by an ophthalmic surgeon via intracameral route, through the side port or principal port |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subjects of age between 18 to 75 years (both inclusive).
2.Subjects having grade 2 to 3 Cataract shall be included.
3.Subjects scheduled to undergo surgery for cataract.
4.Endothelial cell count > 2000 cell/mm2.
5.Pupil diameter ≥ 7 mm at screening.
6.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures
|
|
| ExclusionCriteria |
| Details |
1.Corrected visual acuity < 0.5.
2.Refractive Error with a spherical equivalent > +6 or smaller - 6 D.
3.Elevated intraocular pressure (higher than 22 mmHg).
4.Current or history within two months prior to baseline of significant ocular disease, e.g., corneal denervation, corneal epithelial defects, dry eye syndrome, ocular trauma to the operative eye, corneal edema, proliferative diabetic retinopathy in the operative eye or ocular infection.
5.In the operative eye, history of chronic or recurrent inflammatory disease, e.g., iritis, scleritis, uveitis, iridocyclitis or rubeosis iritis, lens pseudoexfoliation syndrome with glaucoma or zonular compromise of. Congenital ocular anomaly, e.g., aniridia or congenital cataract.
6.Iris atrophy in the operative eye.
7.Combined surgery
8.Clinically significant ocular endothelial dysfunction.
9.History of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery.
10.Topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to study-start.
11.Nonfunctional nonoperative eye.
12.Any laboratory value outside the clinically accepted reference range
13.Subjects with Type 1 or Uncontrolled Type 2 Diabetes mellitus.
14.History of uncontrolled hypertension with blood pressure > 140/90 mmhg.
15.History of orthostatic hypotension, fainting spells or blackout.
16.Subjects with clinically relevant recent current or past history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, Gastrointestinal, metabolic, autoimmune disease and other relevant systemic diseases or bleeding tendencies that would preclude the safe administration of the Investigational product.
17.The following concomitant medications will not be allowed:
- Systemic corticoid treatments and immunosuppressive treatments within 3 months before surgery;
-Systemic opioids and morphinic drugs within 7 days before surgery.
-Topical ocular treatment with mydriatic and/or anaesthetic action within 7 days before surgery;
-topical treatment with anti-inflammatory and antibiotic action within 1 day before surgery (except for the preoperative treatment specified in this protocol);
-anxiolytics and hypnotics on the day of surgery; adrenaline or any other agent with a mydriatic action in the intraocular irrigating solution on the day of surgery.
19.Known hypersensitivity to the active substances (tropicamide, phenylephrine, lidocaine,) or any of their excipients
20.Use of any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study
21.Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
22.History of alcohol abuse and smoking.
23.Concurrent participation in another clinical trial or any investigational therapy within two months prior to signing informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The incidence of Adverse Events related to study medication.
2.Change in best corrected visual acuity according to the Snellen test from baseline to end of study
3.Percentage of subjects with epithelial alterations evidenced by slit-lamp examination at visit 3 and visit 4.
4.Change in endothelial cells count from baseline to end of study.
5.Change in intraocular pressure from baseline to end of study.
|
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Percentage of subjects achieving capsulorhexis (Pupil diameter) without use of any additive mydriatic treatment.
2.Change in Ocular pain and discomfort from baseline to end of study.
3.Subjects’ satisfaction with study medications as assessed on an ordinal scale at visit 2 to end of the study.
4.Investigator’s satisfaction with study treatments as assessed on an ordinal scale at visit 2 to end of the study
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="219"
Sample Size from India="219"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/04/2021 |
| 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="6"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
A Study is A Phase IV,
multicentre, open label, clinical study to evaluate the safety and efficacy of
intracameral Phenocaine Plus injection for
anaesthesia and mydriasis in cataract surgery.
Primary Endpoints
The incidence of Adverse Events related to study
medication.
Change in best corrected visual acuity according to
the Snellen test from baseline to end of study
Percentage of subjects with epithelial alterations
evidenced by slit-lamp examination at visit 3 and visit 4.
Change in endothelial cells count from baseline to end
of study.
Change in intraocular pressure from baseline to end of
study.
Secondary Endpoints
Percentage of subjects achievingcapsulorhexis
(Pupil diameter) without use
of any additive mydriatic treatment.
Change in Ocular pain and discomfort from baseline to
end of study.
Subjects’ satisfaction with study medications as
assessed on an ordinal scale at visit 2 to end of the study.
Investigator’s satisfaction with study treatments
as assessed on an ordinal scale at visit 2 to end of the study
|