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CTRI Number  CTRI/2024/01/062041 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 04/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Use of Insulin Eye drops for treatment of corneal epithelial defects that do not heal with conventional medical therapy 
Scientific Title of Study   Use of topical Insulin for management of refractory persistent epithelial defects (PED) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parul Jain 
Designation  Associate Professor 
Affiliation  Guru Nanak Eye Center, Maulana Azad Medical College 
Address  Department of Ophthalmology, Guru Nanak Eye Center, Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, Delhi, 110002

Central
DELHI
110002
India 
Phone  9971927902  
Fax    
Email  pjain811@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Avani Hariani 
Designation  Senior Resident 
Affiliation  Guru Nanak Eye Center, Maulana Azad Medical College 
Address  Department of ophthalmology Guru Nanak Eye Center, Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, Delhi, 110002

Central
DELHI
110002
India 
Phone  9833727084  
Fax    
Email  avanihariani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Avani Hariani 
Designation  Senior Resident 
Affiliation  Guru Nanak Eye Center, Maulana Azad Medical College 
Address  Department of ophthalmology, Guru Nanak Eye Center, Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, Delhi, 110002

Central
DELHI
110002
India 
Phone  9833727084  
Fax    
Email  avanihariani@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated hospitals 
 
Primary Sponsor  
Name  Maulana Azad Medical College, Guru Nanak Eye Center 
Address  Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, Delhi, 110002 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Parul Jain  Department of ophthalmology, Guru Nanak Eye Center, Maulana Azad Medical College  Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, Delhi, 110002
Central
DELHI 		 9971927902

pjain811@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College And Associated Hospital, Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H188||Other specified disorders of cornea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Topical Insulin Eye Drops  Insulin eye drops will be prepared at a concentration of 1 IU/ml, using regular insulin (rDNA human monocomponent regular insulin 40 IU/ml). The insulin solution (0.25ml i.e. 10 IU) will be diluted in a polyethylene glycol and polypropylene glycol base (10ml) giving a final concentration of 1 IU/ ml which will be given four times a day till the healing of the defect or 1 month whichever is earlier 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients with persistent corneal epithelial defect (due to following etiologies: neurotrophic keratitis, chemical or thermal burns, neuroparalytic, multiple sclerosis, diabetes mellitus, immune mediated, post corneal transplants) of more than 2 weeks duration not responding to conventional treatment
2.Age group more than 18 years.
3.Diabetics and non- Diabetics both
 
 
ExclusionCriteria 
Details  1.Bacterial or fungal infection on corneal swab
2.Patients with immunosuppressed status eg. HIV, Malignancies
3.Unable to comply with tests/follow-up
4.Lid abnormalities (e.g. entropion, ectropion, trichiasis, etc)
5.Pregnant or breastfeeding women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Complete re-epithelisation (percent of people)  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Change in best corrected visual acuity (BCVA)  1 month 
If complete re-epithelisation not achieved, size of corneal epithelial defect   1 month 
Re-epithelialisation time (absence of fluorescein stain) and rate (initial area of PEDmm2/days till re-epithelisation)  1 month 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 
Date of First Enrollment (India)   01/02/2024 
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 Yet Recruiting 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - Proposals should be directed to [avanihariani@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Persistent corneal epithelial defects (PEDs) are difficult to treat and often refractory to conventional treatment. Insulin has been shown to play a role in the epithelial cell proliferation, restoring DNA synthesis and wound healing in the human eyes by acting on the Insulin like growth factor (IGF) receptors. 
Advantages of topical Insulin drops are excellent tolerance, easy availability, cost-effectiveness, non-invasive, lower immune reaction, lower infection rate, longer shelf life and easier handling as compared to the other novel modalities of treatment. This study aims to evaluate the efficacy of topical Insulin in the treatment persistent corneal epithelial defects refractory to usual medical treatment.
 
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