| CTRI Number |
CTRI/2025/05/086457 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Tobramycin 0.3% vs. Dual Therapy with Fortified Cefazolin and Ciprofloxacin in Bacterial Keratitis |
|
Scientific Title of Study
|
Evaluating the Effectiveness of Tobramycin 0.3 percent vs. Dual Therapy with Fortified Cefazolin and Ciprofloxacin in Bacterial Keratitis of moderate severity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
GPR Building, 1st floor, Room 125, clinical research department, L V Prasad Marg
Banjara Hills, Road No:02
Hyderabad 500034
Telangana, India
Hyderabad
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
GPR Building, 1st floor, Room 125, clinical research department, L V Prasad Marg
Banjara Hills, Road No:02
Hyderabad 500034
Telangana, India
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
GPR Building, 1st floor, Room 125, clinical research department, L V Prasad Marg
Banjara Hills, Road No:02
Hyderabad 500034
Telangana, India
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute,
GPR Building, 1st floor, Room 125, clinical research department, L V Prasad Marg
Banjara Hills, Road No:02
Hyderabad 500034
Telangana, India
|
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
L V Prasad Marg
Banjara Hills, Road No:02
Hyderabad 500034
Telangana, India
|
| Type of Sponsor |
Other [Non Profitable Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrBhupesh Bagga |
L V Prasad Eye Institute |
Mudhole
Adilabad
TELANGANA |
9618276424
bhupesh@lvpei.org |
| DrBhupesh Bagga |
L V Prasad Eye Institute |
Adilabad
Adilabad
TELANGANA |
9618276424
bhupesh@lvpei.org |
| DrBhupesh Bagga |
L V Prasad Eye Institute |
Thoodukurthy
Mahbubnagar
TELANGANA |
9618276424
bhupesh@lvpei.org |
| DrBhupesh Bagga |
L V Prasad Eye Institute |
Paloncha
Khammam
TELANGANA |
9618276424
bhupesh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antibiotic Therapy |
Cephazoline and Ciprofloxin combination vs Tobramycin.
Follow-up visits: 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months. |
| Comparator Agent |
Antibiotic Therapy |
Cephazoline and Ciprofloxin combination vs Tobramycin.
Follow-up visits: 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Microbiologically confirmed bacterial keratitis smear or smear negative cases where the the fungus has been ruled out by microscopic examination.
2.No prior study medication use exceeding six times per day for more than 10 days.
3.Corneal infiltrate size 4–6 mm, with stromal involvement not exceeding two-thirds of corneal thickness.
4.Vision in the other eye better than 20/200.
5.Willingness to participate in the study.
6.Non-pregnant individuals.
7.Systemically stable patients.
8.Willingness for admission or regular follow-up.
|
|
| ExclusionCriteria |
| Details |
1.Mixed infection
2.Participant not willing to participate
3.Having Advanced form of infection
4.Limbal involvement
5.Scleral involvement
6.Posterior chamber involvement
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Number of cases achieving medical cure.
2.Incidence of corneal perforations.
3.Number of patients requiring urgent TPK.
|
Follow-up visits: 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Best spectacle-corrected visual acuity (BSCVA) at 3 months. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
09/06/2025 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of the study is to compare the efficacy of Tobramycin topically in the management of moderately severe bacterial keratitis and compare their outcome with the combination of cefazoline and ciprofloxacin |