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CTRI Number  CTRI/2025/07/091618 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To investigate the role of Autologous Platelet Rich Plasma eyedrops in the management of symptomatic Dry Eye Disease 
Scientific Title of Study   To investigate the role of Autologous Platelet rich Plasma eyedrops in the management of symptomatic Dry Eye Disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saba Firdos Khan 
Designation  Assistant Professor 
Affiliation  NSCB Medical college and hospital, jabalpur 
Address  Department of Ophthalmology, NSCB MCH Jabalpur

Jabalpur
MADHYA PRADESH
482003
India 
Phone  9340765178  
Fax    
Email  sabafirdosk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Divya Sharma 
Designation  PG student 
Affiliation  NSCB MCH Jabalpur 
Address  Department of Ophthalmology, NSCB MCH Jabalpur

Jabalpur
MADHYA PRADESH
482003
India 
Phone  8120191043  
Fax    
Email  divya95manju@gmail.com  
 
Details of Contact Person
Public Query  
Name  Divya Sharma 
Designation  PG student 
Affiliation  NSCB MCH Jabalpur 
Address  Department of Ophthalmology, NSCB MCH Jabalpur


MADHYA PRADESH
482003
India 
Phone  8120191043  
Fax    
Email  divya95manju@gmail.com  
 
Source of Monetary or Material Support  
Department of Ophthalmology, NSCB MCH Jabalpur 
 
Primary Sponsor  
Name  Saba Firdos Khan 
Address  Department of Ophthalmology, NSCB MCH Jabalpur 482003, Madhya Pradesh, India 
Type of Sponsor  Government medical college 
 
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 Divya Sharma  NSCB MCH Jabalpur 482003, Madhya Pradesh , India  OPD number 12, Department of Ophthalmology
Jabalpur
MADHYA PRADESH 		 8120191043

divya95manju@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMITTEE, NSCB JABALPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H118||Other specified disorders of conjunctiva,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AUTOLOGOUS PLATELET RICH PLASMA EYEDROPS  Patients will receive topical autologous PRP eye drops prepared from their own blood under aseptic conditions. Blood will be centrifuged to separate platelet-rich plasma, which will be collected, filtered, and dispensed into sterile eye drop vials. PRP will be stored at 4°C and used within 7 days. Patients will instill 1 drop 6 times per day in both eyes for 3 months. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.All patients with symptomatic dry eye with an OSDI score of >40,
2.A TBUT score of <10s ,
3.Positive CFS score
4.Schirmer test score <10mm in 5 mins,
5.Able to give informed consent were included in the study
 
 
ExclusionCriteria 
Details  1.Patients who were unwilling or unable to give consent,
2.Refused follow up plans,
3.Uncooperative patients,
4.Under 18 years of age and over 75 years,
5.Contact lens user,
6.Patients with active ocular infection,
7.Patients with history of refractive surgeries
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in visual acuity, Schirmer score, OSDI, Tear break up time and Corneal staining  baseline, 1 month, 2 months, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 
Date of First Enrollment (India)   05/08/2025 
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="0"
Months="6"
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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 [divya95manju@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 16-01-2045?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This prospective interventional study evaluates the efficacy and safety of autologous platelet-rich plasma (PRP) eye drops in patients with moderate to severe symptomatic dry eye disease unresponsive to conventional therapy. PRP, rich in growth factors and anti-inflammatory mediators, is prepared from the patient’s own blood and applied topically for 12 weeks. Outcome measures include improvement in visual acuity, OSDI score, Schirmer’s test, TBUT, and corneal staining at baseline and follow-up visits. The study aims to assess PRP as a potential biological therapy for ocular surface healing in dry eye disease. 
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