| CTRI Number |
CTRI/2024/04/066329 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness and side effects of Mitomycin c and 5 Fluorouracil eye drops used for treating patients with surface tumor of the conjunctiva of the human eye. |
|
Scientific Title of Study
|
Comparison of Topical Mitomycin C and 5 Fluorouracil as Primary Treatment modalities for Ocular Surface Squamous Neoplasia: A Randomized Controlled Trial 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 |
Khyati Roop |
| Designation |
Post Graduate Resident |
| Affiliation |
Dr Shroff Charity Eye Hospital |
| Address |
A-66 first floor
South extension part-2
Dr Shroff Charity Eye Hospital, Kedarnath lane, New Delhi , 110002
Central
DELHI
110049
India |
| Phone |
7042531633 |
| Fax |
|
| Email |
khyatiroop@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sima Das |
| Designation |
HOD Department of Oculoplastics and Ocular oncology |
| Affiliation |
Dr Shroff Charity Eye Hospital |
| Address |
Dr Shroff Charity Eye Hospital, Kedarnath lane, New Delhi , 110002
Central
DELHI
110002
India |
| Phone |
9910190098 |
| Fax |
|
| Email |
sima.das@sceh.net |
|
Details of Contact Person
Public Query
|
| Name |
Khyati Roop |
| Designation |
Post Graduate Resident |
| Affiliation |
Dr Shroff Charity Eye Hospital |
| Address |
A-66 first floor
South extension part-2
Dr Shroff Charity Eye Hospital, Kedarnath lane, New Delhi , 110002
DELHI
110049
India |
| Phone |
7042531633 |
| Fax |
|
| Email |
khyatiroop@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shroff Charity Eye Hospital |
| Address |
Dr Shroff Charity Eye Hospital, Kedarnath lane, Daryaganj, New Delhi,110002 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Khyati Roop |
Dr Shroff Charity Eye Hospital |
Department of oculoplasty and ocular oncology, Medical education Division , Academic block , room no N/A
Central
DELHI |
7042531633
khyatiroop@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Shroff Charity Eye Hospital 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 |
topical 1% 5 Fluorouracil |
Topical 5 Fluorouracil(antimetabolite) eye drop 1% given 4 times a day for 1 week and then 3 weeks drug holiday used for ocular surface squamous neoplasia |
| Intervention |
Topical Mitomycin C 0.04% |
Topical Mitomycin C (alkylating agent) eye drops in 0.04% given topically 4 times a day for 4 days a week for 4 weeks followed by 2 weeks drug holiday in ocular surface squamous neoplasia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 18 years of age diagnosed with ocular surface squamous neoplasia without scleral or orbital invasion with no history of prior treatment for presenting lesion |
|
| ExclusionCriteria |
| Details |
1)patients with previous history of receiving treatment for presenting lesion
2)patients with advanced cases of ocular surface squamous neoplasia with scleral or orbital invasion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)% reduction in tumor dimensions(in terms of maximum vertical , horizontal dimensions and thickness) at 2 months and 3 months of starting therapy
|
1)% reduction in tumor dimensions(in terms of maximum vertical , horizontal dimensions and thickness) at 2 months and 3 months of starting therapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)time taken to complete clinical resolution of tumor
2)side effects/toxicity profile of each drug at the end of the study |
1) time taken for complete clinical resolution is variable
2)side effect profile at end of study i.e. 1 year 6 months from start |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The primary objective of the study is to compare the efficacy and safety of topical mitomycin c and topical 5 fluorouracil as primary treatment modalities for ocular surface squamous neoplasia(OSSN). OSSN is a spectrum neoplastic pathology ranging from benign to malignant neoplasia arising from the conjunctiva of the eye. Gold standard of treatment includes excision of the tumor with/without double freeze cryotherapy. Recent advances in the treatment involves the use of topical chemotherapeutic agents such as topical interferon alpha2B, mitomycin c 5 fluorouracil as non invasive alternatives for primary therapy. The most popularly used chemotherapy agent is topical interferon alpha2B which has its own drawbacks in terms of limited availability, long duration of therapy with high cost for therapy and need for maintaining a cold chain to ensure efficacy of drug. Although several studies have been done comparing the different chemotherapy agents in as primary therapy in OSSN , however most of the studies done are retrospective in nature with limited literature available comparing topical mitomycin c and topical 5 fluorouracil directly with each other in a head to head comparison in same setting in a randomized manner. Our study aims to provide direct head to head comparison for the effectiveness and safety profile of topical mitomycin c and topical 5 fluorouracil in a randomized controlled study thereby eliminating any pre existing bias in an attempt to create sufficient data to justify use of these as safe , effective , easily available and cost effective treatment alternatives specially in Indian setting. |