| 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
|
|
|
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
|
|
|
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.
|