| CTRI Number |
CTRI/2024/06/069674 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The new use of histoglob injection in people with allergic eye diseases |
|
Scientific Title of Study
|
The naive use of Histoglob in VKC- a pilot study |
| 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 Manmeet Singh |
| Designation |
Ophthalmologist and Fellow in Cornea |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room Number 125, Department of Cornea & Refractive Services, Sankara Eye Hospital
Guntur -Vijayawada highway
Pedakakani
Guntur, 522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9340000080 |
| Fax |
|
| Email |
drmanmeetsingh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sudhakar Potti |
| Designation |
Co-Investigator (Scientific Query) |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room number 125, Department of Cornea & Refractive Services, Sankara Eye Hospital
Guntur -Vijayawada highway
Pedakakani
Guntur, 522509
Guntur -Vijayawada highway
Pedakakani
Guntur, 522509
Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
|
| Fax |
|
| Email |
sudhakar@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manmeet Singh |
| Designation |
Fellow in Cornea |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room number 125, Department of Cornea & Refractive Services, Sankara Eye Hospital
Guntur -Vijayawada highway
Pedakakani
Guntur, 522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9340000080 |
| Fax |
|
| Email |
drmanmeetsingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Vijayawada-guntur Expressway, Pedakakani, Andhra Pradesh, India, 522509 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Vijayawada-Guntur Expressway, Pedakakani,Guntur,Andhra Pradesh, India 522509 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manmeet singh |
Sankara Eye Hospital, Guntur |
Room no 125,
Department of Cornea and Refractive services
Ground floor
Guntur
ANDHRA PRADESH |
9340000080
drmanmeetsingh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Kanchikamakoti medical trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H101||Acute atopic conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Histoglob |
Giving 1 ml dose of histoglob injection sub cutaneously at weekly interval for three weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with newly diagnosed and recurrent allergic eye diseases |
|
| ExclusionCriteria |
| Details |
Symptomatic patients of less than 6 months duration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to check how much reduction in the steroid dependence occurs as a result of intervention of this injection. |
The outcomes will be assessed and compared as baseline, week 1, 2 and 3 post injection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Minimising the steroid induced complications like glaucoma and cataract
To bring down the cost of treatment |
3 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
Months="3"
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
- 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).
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmanmeetsingh@yahoo.com].
- For how long will this data be available start date provided 02-01-2024 and end date provided 12-03-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Background: Vernal Keratoconjunctivitis is a chronic inflammation of the conjunctiva affecting predominantly children in developing, hot and humid conditions, especialy spring season and it sometimes persists throughout the year. Patients are exposed to longer use of topical steroids to contain the inflammation but in turn, which has a drastic impact leading to steroid induced glaucoma which is a matter of concern younger population loosing sight.
Purpose: To address this loss (steroid induced glaucom/cataract) should not happen due to longer use of topical steroids, we thought of doing research alternatives in the best interest of the visual health of the patients of Vernal Keratoconjuctivitis (VKC) by using Inj Histoglob in such patients in our pilot study |