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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.

Comparison of Topical Mitomycin C and 5 Fluorouracil as Primary Treatment modalities for Ocular Surface Squamous Neoplasia: A Randomized Controlled Trial Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066329
Enrollment
60
Registered
2024-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C690- Malignant neoplasm of conjunctiva

Interventions

Intervention1: 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 ocul

Sponsors

Dr Shroff Charity Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1)% reduction in tumor dimensions(in terms of maximum vertical , horizontal dimensions and thickness) at 2 months and 3 months of starting therapy Timepoint: 1)% reduction in tumor dimensions(in terms of maximum vertical , horizontal dimensions and thickness) at 2 months and 3 months of starting therapy

Secondary

MeasureTime frame
1)time taken to complete clinical resolution of tumor 2)side effects/toxicity profile of each drug at the end of the studyTimepoint: 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

Countries

India

Contacts

Public ContactKhyati Roop

Dr Shroff Charity Eye Hospital

sima.das@sceh.net9910190098

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026