| CTRI Number |
CTRI/2023/04/051652 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Bacterial Keratitis |
Scientific Title of Study
Modification(s)
|
Efficacy of Topical Polymyxin B/Trimethoprim + Rifampin for the Treatment of Keratitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Prashant Garg |
| Designation |
consultant-Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,Room No:123,Clinical Research Department, GPR building, Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No 2, Hyderabad, Telangana - 500034
L V Prasad Eye Institute,Room No:123,Clinical Research Department, GPR building, Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No 2, Hyderabad, Telangana - 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9849593572 |
| Fax |
04023548271 |
| Email |
prashant@lvpei.org |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Bhupesh Bagga |
| Designation |
consultant-Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,Room No:123,Clinical Research Department, GPR building, Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No 2, Hyderabad, Telangana - 500034
L V Prasad Eye Institute,Room No:123,Clinical Research Department, GPR building, Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No 2, Hyderabad, Telangana - 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr. Bhupesh Bagga |
| Designation |
consultant-Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,Room No:123,Clinical Research Department, GPR building, Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No 2, Hyderabad, Telangana - 500034
L V Prasad Eye Institute,Room No:123,Clinical Research Department, GPR building, Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No 2, Hyderabad, Telangana - 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,Room No:123,Clinical Research Department, GPR building, Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No 2, Hyderabad, Telangana - 500034 |
| Type of Sponsor |
Other [Non profitable organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant Garg |
L V Prasad Eye Institute |
Room No:123,Clinical Research Department, GPR building, Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No 2, Hyderabad, Telangana - 500034
Hyderabad
TELANGANA |
9849593572
04023548271
prashant@lvpei.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
PT and rifampin ophthalmic solution containing polymyxin B, trimethoprim and Rifampin (10,000 units polymyxin B, 1 mg per ml trimethoprim, and 0.5 mg per ml rifampin) |
1 drop in the study eye every 2 hours while awake and approximately 4 and 6 hours after retiring on Days 1-3.
1 drop 4 times daily while awake on Day 4 through completion
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects have given written informed consent to participate in the study
2.Subject has a clinical diagnosis of suspected bacterial keratitis in one eye only (study eye) defined as an ulceration of the epithelium characterized by fluorescein staining with focal or diffuse suppurative stromal inflammation, cellular infiltration in the adjacent stroma with or without anterior chamber cellular reaction
3.If subject is a female of childbearing potential, she must utilize a reliable contraceptive method [chemical contraceptive (oral, implantable, or injectable), spermicide with barrier, or IUD] throughout the study, and must have a negative urine pregnancy test prior to enrollment in this study
4.Subject is 18 years of age or older
5.Subject understands the scope of the study and is willing to follow instructions and able to make all required study visits
6.Subjects has best-corrected visual acuity (ETDRS) of +1.0 logMAR (Snellen equivalent 20/200) or better in the fellow eye
|
|
| ExclusionCriteria |
| Details |
1.Presence of suspected fungal, viral, or parasitic ocular infection in the study eye.
2.A significant thinning (>50%) of corneal stroma.
3.Females who are lactating, pregnant or are planning a pregnancy, or females of childbearing potential not using a reliable method of contraception.
4.Contact lens wear in the study eye during study period.
5.Use of any topical non-ocular or systemic antimicrobial (including subconjunctival injections) or steroid within 24 hours prior to enrollment into the study or during the study.
6.Use of topical ocular antimicrobial or steroid solution in the study eye within 2 hours prior to enrollment into the study or during the study. Patients should not have been on other pre-study antimicrobial therapy for corneal ulcers for >24 hours.
7.Subject with suspected bacterial endophthalmitis or bacterial scleritis.
8.Use of any systemic/topical investigational drug or device during the study or within 30 days before receipt of study medication. Patients cannot have previously been enrolled in this study.
9.Ocular surgery in the study eye within six weeks before the beginning of the study.
10.Cardiovascular or respiratory surgery within six weeks before the beginning of the study.
11.History of allergy or sensitivity to polymyxin B, trimethoprim, rifamycin or any component of the study medications, including the preservative BAK.
12.Current alcohol and/or drug abuse.
13.History of retinal detachment, diabetic retinopathy, or any retinal disease which may be progressive during the study.
14.Any history of uncontrolled chronic systemic disease (e.g., cardiovascular disease, hypertension, or diabetes).
15.Any history of autoimmune disease that the investigator feels may interfere with the study parameters (e.g., acquired immune-deficiency syndrome or rheumatoid arthritis).
16.Any abnormality or presence of any significant illness that could interfere with the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy variable is clinical cure (i.e., complete re-epithelialization of the infected cornea and no progression from baseline of the stromal infiltrate) at the clinical Cure Visit (Endpoint) with confirmation at the Confirmatory Visit. |
Day 1, day 2 or 3, Day 5, 8,12, 18 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
•Best Corrected Visual Acuity (BCVA)
•Cure rate at selected timepoints
•Cure rate at Endpoint by baseline epithelial defect size
•Time to Clinical Cure
•Treatment failures
•Adverse events & other therapeutic side effects
•Relapse of cure
•Cure rate based on organism
|
• Visit 1 (Day 0),
• Visit 2 (Day 1,2,3)
• Visit 3-8 (Days 4-19)
• Confirmatory Visit/End of Trial (Day 3±2 of Post Clinical Cure Visit) |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a prospective interventional academic single center trial evaluating the efficacy of Topical Polymyxin B/Trimethoprim + Rifampin for the treatment of Keratitis in 25 patients who have been diagnosed with Bacterial Keratitis at LVPEI, Hyderabad. The primary efficacy variable is clinical cure (i.e., complete re-epithelialization of the infected cornea and no progression from baseline of the stromal infiltrate) at the clinical Cure Visit (Endpoint) with confirmation at the Confirmatory end. |