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CTRI Number  CTRI/2023/04/051652 [Registered on: 17/04/2023] Trial Registered Prospectively
Last Modified On: 18/03/2026
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   Safety and Efficacy of Polymyxin B, Trimethoprim plus Rifampin for the Treatment of bacterial infectious Keratitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAmrita Mohanty 
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  9937876318  
Fax  04023548271  
Email  dramritamohanty@lvpei.org  
 
Details of Contact Person
Scientific Query  
Name  DrAmrita Mohanty 
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

TELANGANA
500034
India 
Phone  9937876318  
Fax  04023548271  
Email  dramritamohanty@lvpei.org  
 
Details of Contact Person
Public Query  
Name  DrAmrita Mohanty 
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

TELANGANA
500034
India 
Phone  9937876318  
Fax  04023548271  
Email  dramritamohanty@lvpei.org  
 
Source of Monetary or Material Support  
L V Prasad Eye Institute 
 
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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAmrita Mohanty  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 		 9937876318
04023548271
dramritamohanty@lvpei.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee, L V Prasad Eye Institute  Approved 
Ethics Committee, L V Prasad Eye Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
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.Size of the ulcer <1mm or >6mm.
3.Presence of corneal thinning >50% or any signs of perforation or near perforation.
4.Females who are lactating, pregnant or are planning a pregnancy, or females of childbearing potential not using a reliable method of contraception
5.Contact lens wear in the study eye during study period
6.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
7.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. Patient should not have been on other pre-study antimicrobial therapy for corneal ulcer for >24 hours
8.Subject with suspected bacterial endophthalmitis or bacterial scleritis.
9.Use of any systemic/topical investigational drug or device during the study or within 30 days before receipt of study medication. Patient cannot have previously been enrolled in this study
10.Ocular surgery in the study eye within six weeks before the beginning of the study
11.Cardiovascular or respiratory surgery within six weeks before the beginning of the study
12.History of allergy or sensitivity to polymyxins, trimethoprim, rifampins, or any component of the study medications, including the preservative BAK
13.Current alcohol and/or drug abuse
14.History of retinal detachment, diabetic retinopathy, or any retinal disease which may be progressive during the study
15.Any history of uncontrolled chronic systemic disease (e.g., cardiovascular disease, hypertension, or diabetes)
16.Any history of autoimmune disease that the investigator feels may interfere with the study parameters (e.g., acquired immune-deficiency syndrome or rheumatoid arthritis)
17.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  
Outcome  TimePoints 
Cure rate at selected timepoints
Cure rate at Endpoint by baseline epithelial defect size
Investigator’s clinical impression
Treatment failures
Adverse events and other therapeutic side effects
 		 Visit 1 (Day 1), Visit 2 (Day 2 or 3), Day 5±1, Day 8±1, Day 12±2, Day 18±3, Confirmatory visit (2 to 5 days after 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)   20/04/2023 
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. 
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