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CTRI Number  CTRI/2024/01/061897 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 09/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Trial on Dry Eyes  
Scientific Title of Study   Intraglandular platelet rich plasma injection in moderate to severe dry eye disease: A placebo-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  Dr Swati Singh 
Designation  Consultant Opthalmologist 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, GPR Building, 1st Floor, Clinical Research Department, Room No:123, Banjara Hills, Road No: 02 Hyderabad-500034, Telangana,India

Hyderabad
TELANGANA
500034
India 
Phone  04068102123  
Fax    
Email  swatisingh@lvpei.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Singh 
Designation  Consultant Opthalmologist 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, GPR Building, 1st Floor, Clinical Research Department, Room No:123, Banjara Hills, Road No: 02 Hyderabad-500034, Telangana,India


TELANGANA
500034
India 
Phone  04068102123  
Fax    
Email  swatisingh@lvpei.org  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Singh 
Designation  Consultant Opthalmologist 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, GPR Building, 1st Floor, Clinical Research Department, Room No:123, Banjara Hills, Road No: 02 Hyderabad-500034, Telangana,India


TELANGANA
500034
India 
Phone  04068102123  
Fax    
Email  swatisingh@lvpei.org  
 
Source of Monetary or Material Support  
L V Prasad Eye Institute Banjara Hills, Road No: 02, Hyderabad 500034 Telangana, India 
 
Primary Sponsor  
Name  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, GPR Building, 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 
Dr Swati Singh  L V Prasad Eye Institute  GPR Building, 1st Floor, Clinical Research Department, Room No:123, Banjara Hills, Road No: 02, Hyderabad-500034, Telangana,India
Hyderabad
TELANGANA 
7036981646

swatisingh@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: H041||Other disorders of lacrimal gland,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  injection normal saline 
Intervention  Platelet rich rich plasma injection  Patients own blood will be collected for plasma formulation and injected in to the gland. The dose is 0.5 to 1cc. Frequency is once in 2 weeks. Route of administration is transconjunctival,duration of the study is 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Aged 18–70 years
2. Have OSDI scores ≥33 or Oxford staining grade ≥2
3. Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logMAR
4.Diagnosis of DED in both eyes supported by the criteria mentioned below
Defined by at least one eye meeting all the following criteria:
o A symptom severity score of ≥22 for OSDI
o An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤5 mm per 5 minutes
o Evidence of ocular surface staining (total fluorescein staining score of at least 3) [0-15 scale])
5. Have normal lid anatomy and no other ocular disease except refractive errors or cataract
 
 
ExclusionCriteria 
Details  1. Uncontrolled systemic diseases, active infection or chronic kidney disease, liver cirrhosis, advance cancer.
2. Pregnant or nursing women.
3.Have not recently used the following medications, interventions, surgery, Anticoagulants or anti-platelets,Topical undiluted blood products within 3 months, Punctal plug or contact lenses, Ocular surgery within 6 months.
4.Have no contraindication for blood donation, Positive HIV, hepatitis B or C, or syphilis, Anaemia.Hemoglobin less than 110 grams per Litre.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change from baseline in total corneal staining  week 4, week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change from baseline in the score of dry eye questionnaires, change in Schirmer values & NIBUT, degree of burning or stinging sensation  week 4, week 12 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/01/2024 
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="6"
Days="1" 
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 - NO
Brief Summary  

Patients with moderate to severe dry eye disease due to lack of lacrimal gland function will receive PRP injection fortnightly for one month and it will be compared with placebo injection.

Purpose of the study is to evaluate the efficacy of intraglandular PRP injection in dry eyes.

 
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