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CTRI Number  CTRI/2025/08/093522 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of immune suppressing eye drops in corneal infection caused by fungus 
Scientific Title of Study   Fungal ulcer Augmented treatment with Natamycin and Cyclosporine Trial – Pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Josephine Christy 
Designation  Head of the Department, Cornea 
Affiliation  Aravind Eye Hospital, Pondicherry, India 
Address  Department of Cornea, Room no.25, Aravind eye hospital , Thavalakuppam, Cuddalore road, Pondicherry 605007
Aravind eye hospital , Thavalakuppam, Cuddalore road, Pondicherry 605007
Pondicherry
PONDICHERRY
605007
India 
Phone  9994549584  
Fax    
Email  josyfred@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Josephine Christy 
Designation  Head of the Department, Cornea 
Affiliation  Aravind Eye Hospital, Pondicherry, India 
Address  Department of Cornea, Room no.25, Aravind eye hospital , Thavalakuppam
Aravind eye hospital , Thavalakuppam, Cuddalore road, Pondicherry 605007
Pondicherry
PONDICHERRY
605007
India 
Phone  9994549584  
Fax    
Email  josyfred@gmail.com  
 
Details of Contact Person
Public Query  
Name  Josephine Christy 
Designation  Head of the Department, Cornea 
Affiliation  Aravind Eye Hospital, Pondicherry, India 
Address  Department of Cornea, Room no 25, Aravind eye hospital , Thavalakuppam
Aravind eye hospital , Thavalakuppam, Cuddalore road, Pondicherry 605007
Pondicherry
PONDICHERRY
605007
India 
Phone  9994549584  
Fax    
Email  josyfred@gmail.com  
 
Source of Monetary or Material Support  
Aravind Eye Hospital Cuddalore road Thavalakuppam Pondicherry-605007 India & Francis I Proctor foundation UCSF, 490, Illinois street,Floor 2, San Francisco, California-94158  
 
Primary Sponsor  
Name  Aravind Eye Hospital  
Address  Thavalakuppam, Cuddalore road, Pondicherry 605007 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Francis I Proctor foundation  University of California, 490 Illinois street, Floor 2, San Francisco, California 94158 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Josephine Christy  Aravind Eye Hospital  Aravind Eye Hospital, Thavalakuppam, Cuddalore main road
Pondicherry
PONDICHERRY 		 9994549584

josyfred@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aravind Eye Hospital, Pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H160||Corneal ulcer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fungal ulcer treated with antifungas with 0.1% cyclosporine or 2% cyclosporine  In addition to conventional antifungal eye drops, 0.1% or 2% cyclosporine eye drops will be used as 4 times a day dosing for 1 month and twice a day dosing for 1 month. 
Comparator Agent  Fungal ulcer treated with conventional antifungals and lubricant (placebo)   Conventional Antifungal eye drops like natamycin 5% and/or Voriconazole 1% or Amphotericin B drops 0.15 % until healing of corneal ulcer (1-2 months). Placebo - Hydroxypropyl methyl cellulose eye drops will be used as 4 time a day for 1 month and 2 times a day for 1 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Smear or culture positive for fungal keratitis, of any size and
Visual acuity of worse than 6/12 and better than 3/60
 
 
ExclusionCriteria 
Details  Impending perforation/perforation/endophthalmitis
Evidence of acanthamoeba by stain/herpetic keratitis by history or exam/bacterial mixed infection
History of corneal scar in the affected eye and best corrected visual acuity worse than 6/60 in other eye
Bilateral ulcers
Previous penetrating keratoplasty
Known allergy to study medications (cyclosporine or preservative)
Previous history of topical steroid/native medication use
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Best corrected visual acuity at 3 months between the placebo and intervention groups  Best corrected visual acuity at 3 months between the placebo and intervention groups 
 
Secondary Outcome  
Outcome  TimePoints 
Scar size   3 months 
Corneal perforation and need for therapeutic keratoplasty  3 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 2/ Phase 3 
Date of First Enrollment (India)   05/09/2025 
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="0"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  REDCAP DATA ENTRY PORTAL

  6. For how long will this data be available start date provided 09-06-2025 and end date provided 09-06-2026?
    Response (Others) -  DURING THE STUDY RECRUITMENT, ANALYSIS AND PUBLICATION PERIOD

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Corneal ulcers caused by fungus are associated with worse visual outcomes compared to other causes of infectious keratitis. Incidence of fungal corneal account for 35-44% of corneal ulcers in South India. “Successful" treatment is not always associated with a good visual outcome as the scar that accompanies resolution of fungal keratitis leaves many eyes blind. The host inflammatory response is required for immune protection, but can also lead to pathological tissue damage if not controlled. Topical steroids, can be beneficial as adjunctive therapy with bacterial keratitis, are not used with fungal keratitis as they promote fungal growth and worsen the infection. Topical cyclosporine demonstrates anti-fungal activity in vitro and modify inflammation via a different mechanism than topical steroids. The main objective of this study is to decrease vision loss from fungal ulcers by studying and predicting which cases of fungal keratitis may benefit from adjuvant topical cyclosporine.

 
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