| CTRI Number |
CTRI/2010/091/001136 [Registered on: 18/08/2010] |
| 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)
|
A clinical Trial in patients with inflammatory ocular conditions. Clinical trial is to study efficacy, safety and tolerability of Gatifloxacin 0.3 % + Difluprednate 0.05 % eye drops in comparison to Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops. |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Single blind, Multicentric,
Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Gatifloxacin 0.3 % + Difluprednate 0.05 % eye drops Vs. Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops in patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| APL / CT / 09 / 024 |
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 (W)
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 (W)
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 (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Ajanta Pharma Ltd. Advent, 43/44, ABCD, Charkop Industrial Estate, Kandivli (W), Mumbai - 400 067, Maharashtra, India. |
|
Primary Sponsor
Modification(s)
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd., Advent, 43/44, ABCD, Charkop Industrial
Estate, Kandivli (W)
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 Nimisha Patel |
Divya jyot eye hospital, |
Divya jyot eye hospital,
Natraj Complex,,
B. K. Road,
Mehasana
Gujarat
Mahesana
GUJARAT |
09825192139
dr.bhavesh_patel@yahoo.co.in |
| Dr. Sharad Mistry |
Dr. Sharad Mistry's Clinic |
Sector 3,A-43, Shanti Nagar,,Mira Road (east)-401104
Thane
MAHARASHTRA |
esmile1614@yahoo.co.in |
| Dr Mital Patel |
The Baroda association for the blind, |
The Baroda association
for the blind,
Near Elct. Sub-stn,
,Subhanpura,
Vadodara, Gujarat
Vadodara
GUJARAT |
09327412323
mitalnirav@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Jagruti - Independent Ethics Committee, Mumbai, Maharashtra |
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 |
Inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists, (1) ICD-10 Condition: H018||Other specified inflammations of eyelid, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Gatifloxacin 0.3 % + Difluprednate 0.05 % Eye Drops |
Instill 1 drop four times a day for 7 days |
| Comparator Agent |
Gatifloxacin 0.3% + Dexamathasone 0.1% eye drops |
Instill 1 drop four times a day for 7 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.
2.Patients showing an anterior chamber cell score of not less than 2 at a day after surgery.
3.Written informed consent to participate to the trial. |
|
| ExclusionCriteria |
| Details |
1.Patients < 18 & > 60 years.
2.Patients who took systemic administration of corticosteroids or immunosuppressive agents in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded.
3.Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs;
4.Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery);
5.Patients who underwent perioperative and/or postoperative intravitreous injection of corticosteroids;
6.Patients who underwent sub-conjunctival injection
7.Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations;
8.Patients who underwent gas tamponade at the surgery;
9.Patients with endogenous uveitis;
10.Patients having corneal epithelial detachment or corneal ulcer in the target eye;
11.Patients who are suspected of having viral, bacterial or mycotic keratoconjunctival disorders in the target or opposite eye;
12.Patients with glaucoma or ocular hypertension, or those with past history of IOP increased due to instillation of corticosteroids, or those whose IOP has been controlled by use of ophthalmic antihypertensive agents;
13.Patients showing IOP not less than 25 mmHg a day after surgery;
14.Patients who have allergy to corticosteroid drugs;
15.Patients who are required to wear contact lens during the study period;
16.Patients who are scheduled to undergo surgery of the opposite eye during the study period;
17.Patients who are pregnant or may be pregnant or lactating;
18.Patients who have participated in other clinical studies within 3 months.
|
|
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 |
| Slit Lamp Biomicroscopic Examination |
Day 0, Day 3, Day 5 and Day 7. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Conjunctival hyperaemia, Corneal and lid oedema, Ocular Infection, pain, photophobia and tearing will be assessed and observation will be graded as 0 Nil, 1 Mild, 2 Moderate, 3 Severe. |
Day 0, Day3, Day 5 and Day 7. |
|
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)
|
23/08/2010 |
| 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="7" |
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, single blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Gatifloxacin 0.3 % + Difluprednate 0.05 % eye drops Vs. Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops in 100 patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists. Date of first enrollment will be 23 August 2010.
The primary outcome measures will be Slit Lamp Biomicroscopic Examination at day 0, Day 3, Day 5 and Day 7. The secondary outcome measures will be Conjunctival hyperaemia, Corneal and lid oedema, Ocular Infection, pain, photophobia and tearing will be assessed and observation will be graded as: 0 = Nil, 1 = Mild, 2 = Moderate, 3= Severe at day 0, Day 3, Day 5 and Day 7. |