| CTRI Number |
CTRI/2025/07/091933 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the effectiveness of a specific eye drops called "Interferon alpha 2b " to treat eye surface tumor. |
|
Scientific Title of Study
|
Efficacy of interferon alpha 2b in treatment of 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 |
Akash khiyani |
| Designation |
DNB RESIDENT |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room 210,Department of Cataract and Intraocular lens,Division : Ophthalmology,SV Aravind Eye Hospital
near NCC Campus , Allipiri Cherlopalli road , tirupati , Andhra pradesh
Chittoor
ANDHRA PRADESH
517505
India |
| Phone |
7709436122 |
| Fax |
|
| Email |
khiyani.khiyani3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preeti Mohanty |
| Designation |
Senior Medical Officer |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room 210,Department of Cataract and Intraocular lens,Division : Ophthalmology,SV Aravind Eye Hospital
near NCC Campus , Allipiri Cherlopalli road , tirupati , Andhra pradesh
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
8332023520 |
| Fax |
|
| Email |
preetiliza@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akash khiyani |
| Designation |
DNB RESIDENT |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room 210,Department of Cataract and Intraocular lens,Division : Ophthalmology,SV Aravind Eye Hospital
near NCC Campus , Allipiri Cherlopalli road , tirupati , Andhra pradesh
Chittoor
ANDHRA PRADESH
517505
India |
| Phone |
7709436122 |
| Fax |
|
| Email |
khiyani.khiyani3@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Akash khiyani |
| Address |
Cherlopalli - Alipiri Rd, beside NCC Campus, Tirupati, Andhra Pradesh 517505 |
| Type of Sponsor |
Other [Self (individual)] |
|
|
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 |
| Akash Khiyani |
Sri Venkateswara Aravind Eye Hospital |
Room no. 210 , Department of Orbit and external ocular surface ,Division of Ophthalmology,Cherlopalli - Alipiri Road, beside NCC Campus, Tirupati, Andhra Pradesh 517505
Chittoor
ANDHRA PRADESH |
7709436122
khiyani.khiyani3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H058||Other disorders of orbit, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intalfa 3 million IU/ml |
Reconstituted interferon alpha 2b in distilled water used topically in eye as 1 million IU/ml formulation. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Ocular Surface Squamous Neoplasia |
|
| ExclusionCriteria |
| Details |
Patient already undergoing other ongoing / incomplete treatment were excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Interferon alpha 2b in resolution of the OSSN lesion (both clinically and on slit-lamp examination) |
6 months of Interferon treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to Clinical Resolution
Recurrence Rate
Partial Response Rate
Adverse Effects
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
09/08/2025 |
| 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 - NO
|
|
Brief Summary
|
This is a prospective, interventional, open-label, single-arm clinical study designed to evaluate the efficacy and safety of topical Interferon Alpha-2b in patients diagnosed with Ocular Surface Squamous Neoplasia (OSSN). The study aims to assess the rate of complete clinical resolution of OSSN lesions following treatment with Interferon Alpha-2b eye drops, as well as secondary outcomes including time to resolution, recurrence rate, adverse effects, and patient tolerability.
Patients meeting the inclusion criteria will receive topical Interferon Alpha-2b over a specified treatment period and will be regularly monitored through slit-lamp examination and photographic documentation. The study will provide important data on the therapeutic role of Interferon Alpha-2b in managing OSSN, potentially offering a non-surgical treatment alternative.
|