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CTRI Number  CTRI/2025/04/085722 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Natamycin Monotherapy vs. Natamycin with Posaconazole in Mild to Moderate Fungal Keratitis 
Scientific Title of Study   Comparative Efficacy of Natamycin Monotherapy vs. Natamycin with Posaconazole in Mild to Moderate Fungal Keratitis: A Randomized Controlled Trial  
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, Room No:125, Clinical research department, 1st floor, GPR building,L V Prasad Marg Banjara Hills, Road No:02 Hyderabad 500034 Telangana, India

Hyderabad
TELANGANA
500034
India 
Phone  04068102615  
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, Room No:125, Clinical research department, 1st floor, GPR building,L V Prasad Marg Banjara Hills, Road No:02 Hyderabad 500034 Telangana, India


TELANGANA
500034
India 
Phone  04068102615  
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, Room No:125, Clinical research department, 1st floor, GPR building,L V Prasad Marg Banjara Hills, Road No:02 Hyderabad 500034 Telangana, India


TELANGANA
500034
India 
Phone  04068102615  
Fax    
Email  bhupesh@lvpei.org  
 
Source of Monetary or Material Support  
L V Prasad Eye Institute, Room No:125, Clinical research department, 1st floor, GPR building,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 Marg Banjara Hills, Road No:02 Hyderabad 500034 Telangana, India 
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 
DrBhupesh Bagga  L V Prasad Eye Institute  L V Prasad Eye Institute, Room No:125, Clinical research department, 1st floor, GPR building,L V Prasad Marg Banjara Hills, Road No:02 Hyderabad 500034 Telangana, India
Hyderabad
TELANGANA 		 9618276424

bhupesh@lvpei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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  Antifungal Therapy  Follow ups on 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months. Natamycin monotherapy versus Natamycin with Posaconazole  
Intervention  Antifungal Therapy  Natamycin monotherapy versus Natamycin with Posaconazole. Follow ups on 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 fungal keratitis (smear and/or culture positive).
2.No prior antifungal use exceeding six times per day for more than 10 days.
3.Corneal infiltrate size 2–6 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.
 		 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Number of patients requiring urgent TPK.  1 week, 2 weeks, 1 month, 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)   09/05/2025 
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="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This study aims to assess whether the addition of Posaconazole to Natamycin improves treatment outcomes in mild to moderate fungal keratitis. The findings will help refine treatment protocols and provide insights into the efficacy of combination antifungal therapy.

 
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