| CTRI Number |
CTRI/2024/03/064353 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Local injections versus eyedrops Interferon in ocular surface squamous neoplasia |
|
Scientific Title of Study
|
Perilesional injections versus topical interferon alpha 2b in ocular surface squamous neoplasia |
| 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 Nandini Gupta |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Science |
| Address |
Dr Rajendra Prasad Centre of Ophthalmic Sciences,All India Institute Of Medical Science, Aurobindo Marg, Ansari nagar, NewDelhi
South
DELHI
110029
India |
| Phone |
9466726231 |
| Fax |
|
| Email |
guptanandining7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neiwete Lomi |
| Designation |
Associate Professor |
| Affiliation |
DR RP CENTRE OF OPHTHALMIC SCIENCES |
| Address |
Dr Rajendra Prasad Centre of Ophthalmic Sciences,All India Institute Of Medical Science, Aurobindo Marg, Ansari nagar, NewDelhi
South
DELHI
110029
India |
| Phone |
9013590844 |
| Fax |
|
| Email |
neiwete@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neiwete Lomi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Science |
| Address |
Dr Rajendra Prasad Centre of Ophthalmic Sciences,All India Institute Of Medical Science, Aurobindo Marg, Ansari nagar, NewDelhi
DELHI
110029
India |
| Phone |
9013590844 |
| Fax |
|
| Email |
neiwete@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Centre of Ophthalmic Sciences,All India Institute Of Medical Science, Aurobindo Marg, Ansari nagar, NewDelhi |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre of Ophthalmic Sciences |
| Address |
Aurobindo Marg, Ansari Nagar,NewDelhi |
| Type of Sponsor |
Government medical college |
|
|
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 Nandini Gupta |
All India Institute Of Medical Science |
Room No 477, Fourth floor
Dr Rajendra Prasad Centre of Ophthalmic Sciences, Aurobindo Marg, Ansari nagar, NewDelhi
South
DELHI |
9466726231
guptanandining7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C690||Malignant neoplasm of conjunctiva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Interferon alpha 2b eyedrops |
Interferon alpha 2b eyedrops will be given for ocular surface squamous neoplasia for 4 months |
| Intervention |
Interferon alpha 2b perilesional injection |
Perilesional injections of interferon alpha 2b will be given for ocular surface squamous neoplasia for 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All clinically and cytologically diagnosed OSSN
Patient willing to participate and follow up |
|
| ExclusionCriteria |
| Details |
Patient already on topical or perilesional immunotherapy/chemotherapy
/radiotherapy
Patient having any comorbidity
Intraocular or orbital OSSN (AJCC stage T3 OR T4)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome of treatment response clinically (Measured using slit lamp photography)
Severity of side effects(flu like syndrome, hyperemia/follicular conjunctivitis) by each treatment modality
Duration of recurrences if any |
1 month,2 month,3 month,4 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyse changes in ocular surface using (OSA) ocular surface analyser (Tear osmolarity/ Lipid layer thickness/Tear meniscus/Non invasive breakup time/ Meibography/Ocular redness classification) |
1 month,2 month,3 month,4 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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/03/2024 |
| 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 - NO
|
|
Brief Summary
|
This is a prospective randomised comparative interventional study comparing perilesional injection vs eye drops interferon alpha 2b. In perilesional injections,Interferon alpha 2b 3million IU/ml is given directly using tuberculin syringe and 30G needle through adjacent normal conjunctiva into subconjunctival space to achieve subconjunctival ballooning all around tumour. In eye drops,Interferon alpha 2b 3million IU/0.5ml is mixed with 2.5ml carboxymethylcellulose to form 1million IU/ml and patient will be told to put QID continuously. |