| CTRI Number |
CTRI/2017/01/007737 [Registered on: 23/01/2017] Trial Registered Prospectively |
| Last Modified On: |
16/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of the effects of two eyedrops, Nepafenac and Flurbiprofen in reducing pain and inflammation in patients who are undergoing cataract surgery. |
|
Scientific Title of Study
|
A comparative study of efficacy and saftey of topical nonsteriodal anti-inflammatory eye drops in immediate post cataract surgery at a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 01_M001_70153/no version/11.10.2016 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saiyadali Allisabanavar |
| Designation |
MBBS postgraduate in Pharmacology |
| Affiliation |
Bangalore medical college and research institute Bengaluru |
| Address |
Postgraduate in Pharmacology
Bangalore Medical College and Research Institute
Bebgaluru-560002
Bangalore
KARNATAKA
56002
India |
| Phone |
9739458704 |
| Fax |
|
| Email |
saiyadali06bims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saiyadali Allisabanavar |
| Designation |
MBBS ,Postgraduate in Pharmacology |
| Affiliation |
Bangalore medical college and research institute Bengaluru |
| Address |
Postgraduate in Pharmacology
Bangalore Medical College and Research Institute
Bebgaluru-560002.
Bangalore
KARNATAKA
56002
India |
| Phone |
9739458704 |
| Fax |
|
| Email |
saiyadali06bims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narayana Reddy S |
| Designation |
MBBS,MD |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE BENGALURU |
| Address |
Professor in Pharmacology
Bangalore Medical College and Research Institute
Bebgaluru-560002
Bangalore
KARNATAKA
56002
India |
| Phone |
9739458704 |
| Fax |
|
| Email |
dr.narayanareddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Saiyadali Allisabanavar,
Postgraduate in Pharmacology
Bangalore Medical College and Research Institute
Bebgaluru-560002. |
|
|
Primary Sponsor
|
| Name |
Dr Saiyadali Allisabanavar |
| Address |
Postgraduate in Pharmacology
Bangalore Medical College and Research Institute
Bebgaluru-560002.
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saiyadali Allisabanavar |
Minto hospital |
Regional Institute of Ophthalmology, Minto hospital, room no 5,Unit 5 , attached to Bangalore Medical College and Research Institute Bengaluru.
Bangalore
KARNATAKA |
9739458704
9739458704
saiyadali06bims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Uncomplicated cataract patients undergoing phacoemulsification/small incision cataract surgery fulfilling the inclusion/exclusion criteria will be enrolled in the study., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients receiving topically Flurbiprofen 0.03% eye drops thrice daily for 7 days. |
To compare efficacy and saftey of topical Flurbiprofen 0.03% eye drops in reducing ocular pain and inflammation in immediate post cataract surgery . |
| Intervention |
Patients receiving topically Nepafenac 0.1%, eye drops thrice daily for 7 days. |
To compare efficacy and saftey of topical Nepafenac 0.1% eye drop in reducing ocular pain and inflammation in immediate post cataract surgery . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to give written informed consent.
2.Patients undergoing uncomplicated cataract surgery
|
|
| ExclusionCriteria |
| Details |
1.Surgeries other than phacoemulsification/small incisional cataract surgery.
2.Known sensitivity to any of the ingredients in the study medications.
3.Patients with preexisting ocular pathology, inflammation, tumor and glaucoma.
4.History of previous intraocular surgery, uveitis and iritis or intraocular inflammation in the study eye.
5.Use of steroids and Non steroidal inflammatory drugs by systemic route within the 14 days of surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Measuring percentage reduction in pain and is assessed by Visual analogue scale and Anterior Chamber Cells and flare by The Sun Working Group Grading Scheme . |
one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Conjunctival redness by conjunctival hyperemia score and lid edema by Lid edema scoring |
one week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/01/2017 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group trail comparing the safety and efficacy of topical Flurbiprofen 0.03% eye drops thrice daily and topical Nepafenac 0.1%, eye drops thrice daily for one week in 80 patients with uncomplicated cataract undergoing phacoemulsification/small incision cataract surgery fulfilling the inclusion/exclusion criteria that will be conducted in one center in India. The primary outcome measures will be Measuring percentage reduction in pain and is assessed by Visual analogue scale and Anterior Chamber Cells and flare after by Sun Working Group Grading Scheme for one week. The secondary outcomes will be Conjunctival redness by conjunctival hyperemia score and lid edema by Lid edema scoring after one week. |