| CTRI Number |
CTRI/2010/091/001454 [Registered on: 11/10/2010] |
| Last Modified On: |
24/11/2018 |
| 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)
|
Clinical trial is to study efficacy, safety and tolerability of Loteprednol etabonate + Gatifloxacin eye drops in comparison to Gatifloxacin + Dexamethasone eye drops (reference product). |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Loteprednol etabonate 0.5 % + Gatifloxacin 0.3 % eye drops Vs. Gatifloxacin 0.3 % + Dexamethasone 0.1 % eye drops in patients with Inflammatory ocular conditions where bacterial ocular infection or a risk of ocular infection exist.
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| APL/CT/09/025 |
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
43/44, ABCD, Charkop Industrial Estate, Kandivli (West)
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
43/44, ABCD, Charkop Industrial Estate, Kandivli (West)
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
43/44, ABCD, Charkop Industrial Estate, Kandivli (West)
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
43/44, ABCD, 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shilpa Shah |
Aadit Hospital |
Farhin Party Plot,Custom Road, Chala-396191
Valsad
GUJARAT |
09924119912
aadithospital@yahoo.com |
| Dr. Manoj Kumar Agarwal |
Shitij Eye Care Centre |
Kaveri D-002,Vasant Sagar Complex,Thakur Village, Kandivali(E)-400101
Mumbai
MAHARASHTRA |
drma@rediffmail.com |
| Dr Swati Zawar |
Tulsi Eye Hospital |
General Vaidya Nagar,Happy Home colony, Near Dwarka-411011
Nashik
MAHARASHTRA |
09422249913
swati_anuja@yahoo.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Jagruti Independent Ethics Committee Bandra Mumbai 400050 |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400050 |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400050 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
In patients with Inflammatory ocular conditions where bacterial ocular infection or a risk of ocular infection exist., (1) ICD-10 Condition: H571||Ocular pain, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Gatifloxacin + Dexamethasone eye drops |
1 drop 4 times per day for 7 days |
| Intervention |
Loteprednol etabonate + gatifloxacin eye drops |
1 drop 4 times per day for 7 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
2.Subjects who are candidate for routine, uncomplicated cataractsurgery.
3.Subjects who are not of childbearing potential. Subjects must be willing and able to comply with all treatment and follow- up procedures. |
|
| ExclusionCriteria |
| Details |
Patients < 18 & > 65 years.
History of hypersensitivity to the study drug or similar class of drug.
Pregnant or nursing females
Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye. |
|
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 |
| Improvement in ocular inflammation and bacterial infection |
Day 0, day 3, day 5 & day 7. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Global assessment of efficacy and tolerability |
7th day |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
21/10/2010 |
| 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="1"
Days="5" |
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)
|
A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Loteprednol etabonate + Gatifloxacin eye drops Vs.Gatifloxacin + Dexamethasone eye drops in patients with Inflammatory ocular conditions where bacterial ocular infection or a risk of ocular infection exist.The trial will be conducted on 100 patients and study will start on 21 oct 2010.
The primary outcome will be to measured inflammation by slit lamp biomicroscopic & following parameters will be assessed at Day 0, 3rd day, 5th day & 7th day.- Improvement in ocular inflammation and bacterial infection., Red or pink eyes, Eyelids sticking together especially in the morning,Itching,Excess tearing, White-yellow or cream colour thick sticky discharge, Watery discharge,Pain may be present,Virus infections and allergies often affect both eyes,Bleeding or hemorrhage can be seen as rupture of tiny blood vessels,Swelling of conjunctiva,Sensitivity to light,Swelling and redness for as long as 4 to 6 weeks after surgery,Decrease in visual acuity, sometimes caused by cystoid macular edema and secondary outcome will be Global assessment of efficacy and tolerability at 7th day. |