| CTRI Number |
CTRI/2020/01/022874 [Registered on: 20/01/2020] Trial Registered Prospectively |
| Last Modified On: |
16/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the effectiveness, benefits and risks of four eye drops prednisolone acetate 1%, dexamethasone 0.1%, loteprednol etabonate 0.5% and difluprednate 0.05% in patients with red, swollen, painful eyes after cataract surgery. |
|
Scientific Title of Study
|
A comparative, randomized, open label clinical study to assess the efficacy and safety of topical prednisolone acetate 1%, dexamethasone 0.1%, loteprednol etabonate 0.5% and difluprednate 0.05% eye drops in postoperative ocular inflammation following cataract surgery. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr DINKAR BERI |
| Designation |
PG STUDENT CUM TUTOR |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
KIMS COLLEGE, DEPARTMENT OF PHARMACOLOGY, BANASHANKARI 2nd STAGE, BANGALORE
Bangalore
KARNATAKA
560070
India |
| Phone |
8427466335 |
| Fax |
|
| Email |
dinkarberi85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIJENDRA R |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
KIMS COLLEGE, DEPARTMENT OF PHARMACOLOGY, BANASHANKARI 2nd STAGE, BANGALORE
Bangalore
KARNATAKA
560070
India |
| Phone |
9980033334 |
| Fax |
|
| Email |
vijendra_ramaiah@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr DINKAR BERI |
| Designation |
PG STUDENT CUM TUTOR |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
KIMS COLLEGE, DEPARTMENT OF PHARMACOLOGY, BANASHANKARI 2nd STAGE, BANGALORE
Bangalore
KARNATAKA
560070
India |
| Phone |
8427466335 |
| Fax |
|
| Email |
dinkarberi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIMS HOSPITAL, KR ROAD, VV PURAM, BANGALORE 560004 |
|
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Primary Sponsor
|
| Name |
Dr DINKAR BERI |
| Address |
PG student,Department of pharmacology, KIMS College, BSK 2nd stage , BANGALORE 560070 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr DINKAR BERI |
KIMS HOSPITAL |
B BLOCK, OPHTHALMOLOGY OPD (No.8), KR ROAD, VV PURAM, BANGALORE
Bangalore
KARNATAKA |
8427466335
dinkarberi85@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone 0.1% |
Eye drop six times a day in first week, five times a day in second week, four times a day in third week, three times a day in fourth week, two times a day in fifth week, one time a day in sixth week. |
| Intervention |
Difluprednate 0.05% |
Eye drop four times a day in first week, four times a day in second week, three times a day in third week, three times a day in fourth week, two times a day in fifth week, one time a day in sixth week. |
| Intervention |
Loteprednol etabonate 0.5% |
Eye drop six times a day in first week, five times a day in second week, four times a day in third week, three times a day in fourth week, two times a day in fifth week, one time a day in sixth week. |
| Comparator Agent |
Prednisolone acetate 1% |
Eye drop six times a day in first week, five times a day in second week, four times a day in third week, three times a day in fourth week, two times a day in fifth week, one time a day in sixth week. |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with senile cataract with an indication for cataract extraction.
2.Subjects willing to give informed consent and be available for regular follow up.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with congenital and traumatic cataract.
2.Subjects with recurrent infectious and/or inflammatory eye diseases.
3.Subjects with uncontrolled diabetes or associated with complications.
4.Subjects with history of auto-immune diseases.
5.Subjects who are immunocompromised or having tuberculosis, human immunodeficiency virus (HIV) infection.
6.Subjects who develop intra-operative complications during surgery.
7.Subjects with history of hypersensitivity to study drugs.
8.Subjects with history of steroid use 14 days prior to surgery.
9.Subjects with active ocular and/or ENT infections.
10.Subjects with uncontrolled glaucoma.
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Efficacy parameters:
1.Anterior chamber cell and flare grading as per standardization of uveitis nomenclature (SUN).
2.Ocular pain assessed by Visual Analogue Scale (VAS).
|
6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety and tolerability parameters:
1.Intraocular Pressure measured with tonometry.
2.Adverse drug event monitoring.
|
6 weeks |
|
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Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is a randomized, open label, parallel group, single centered, trial comparing the efficacy and safety of prednisolone acetate 1%, loteprednol etabonate 0.5%, dexamethasone 0.1% and difluprednate 0.05% eye drops in post-operative ocular inflammation following cataract surgery for six weeks in 140 patients randomized into 4 groups at department of ophthalmology, KIMS Hospital, VV Puram, Bangalore 560004, India. The primary outcome measures will be Efficacy parameters : Anterior chamber cell and flare grading as per standardization of uveitis nomenclature (SUN), Ocular pain assessed by Visual Analogue Scale (VAS). at six weeks. The secondary outcome measures will be Safety and tolerability parameters : Intraocular Pressure measured with applanation tonometry, Adverse drug event monitoring. at six weeks. Even though there are many studies which have established the efficacy of the commonly used topical corticosteroids, there have been few systematic studies conducted to assess the efficacy and safety of these drugs in postoperative ocular inflammation following cataract surgery in Indian population. Hence, this present study is proposed to be taken up. |