| CTRI Number |
CTRI/2009/091/000830 [Registered on: 20/10/2009] |
| Last Modified On: |
23/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical Trial in patients for ocular surface anesthesia during ophthalmologic procedures. Clinical trial is to study efficacy, safety and tolerability of Lidocaine Hydrochloride Ophthalmic Gel 3.5% in comparison to Akten (reference product). |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Double Blind, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Lidocaine Hydrochloride Ophthalmic Gel 3.5% Vs Akten in patients for ocular surface anesthesia during ophthalmologic procedures. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| APL/CT/09/011 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sharad Mistry |
Dr. Sharad Mistry's Clinic |
Sector 3; A-43,Shanti Nagar. Mira Road (E)-401104
Thane
MAHARASHTRA |
09821711054
esmile1614@yahoo.co.in |
| Dr. Sohan Narkhede |
OM Netralaya |
1st Floor, Siddhi-Prerana Complex, ,Sai Chowk, Navi Sanghvi,-411027
Pune
MAHARASHTRA |
09850019944
sohan_narkhede@yahoo.com |
| Dr. Swapnil Wadgaonkar |
Wadgaonkar Eye Hospital |
126, Madhushri, Varad Ganesh Mandir Road, ,Samarth Nagar,-431001
Aurangabad
BIHAR |
09422206647
wadeyehospital@yahoo.in |
| Dr N T Babu |
Wockhardt Hospital |
14, ,Cunningham Road-560052
Bangalore
KARNATAKA |
09845091197
drbabu_nt@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC - Wockhardt Hospital, Cunningham Road-560052, Bangalore, KARNATAKA |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H590||Disorders of the eye following cataract surgery, Ocular surface anesthesia during ophthalmologic procedures, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Akten |
2 drops will be applied to the ocular surface in the area of the planned procedure |
| Intervention |
Lidocaine Hydrochloride Ophthalmic Gel 3.5% |
2 drops will be applied to the ocular surface in the area of the planned procedure |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 60 years.
2. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
3. Patient undergoing ophthalmologic procedures and requiring ocular anesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients < 18 & > 60 years
2. History of hypersensitivity to the study drug or similar class of drug.
3. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.
4. Pregnant or lactating women.
5. Patients with serum creatinine greater than 2.5 mg/dl.
6. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits
7. Significant history or presence of glaucoma, cardiovascular or hematological disease.
8. Any clinical significant illness during the 4 weeks prior to day 1 of this study.
9. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.
10. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
11. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
12. HIV and Australian Antigen positive subjects.
13. Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Efficacy will be assessed based on following points Grade of anesthesia, Time in onset of anesthesia and Duration of anesthesia
|
0 hr to end of anesthesia |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| safety and tolerability |
0 hr. to day 2nd |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
08/12/2009 |
| 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="0"
Months="2"
Days="17" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a Comparative, Randomized, Double Blind, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Lidocaine Hydrochloride Ophthalmic Gel 3.5% Vs Akten (Reference Drug), in patients for ocular surface anesthesia during ophthalmologic procedures. Date of enrollment is 08 Dec 2009.
Out come will be measured at 0 hr to end of anesthesia in patients for ocular
surface anesthesia during ophthalmologic procedures. The efficacy parameters will primarily focus on Grade of anesthesia, Time in onset of anesthesia and Duration of anesthesia & Secondary focusing on safety and tolerability. |