Adjuvant topical 5fluorouracil (5FU) for ocular surface squamous neoplasia

A double-masked randomised placebo-controlled trial of adjuvant topical 5-fluorouracil (5FU) treatment following surgical excision of ocular surface squamous neoplasia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201207000396219

Enrollment

504

Registered

2012-07-19

Start date

2012-08-03

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Ocular surface squamous neoplasia

Interventions

Artificial tears

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (i) Histologically proven ocular surface squamous neoplasia (OSSN) (ii) attended for post-operative follow-up within the first two months of excision (iii) Healed excision site. (iv) At least 18 years of age.

Exclusion criteria

Exclusion criteria: (i) Prior treatment with topical or subconjunctival antimetabolite drugs such as 5FU, Mitomycin C (MMC) to the same eye or systemic cytotoxic drugs. (ii) Patients who may need more radical surgery than a simple excision eg. features suggestive of metastasis. (iii) Pregnant or breastfeeding mothers.

Design outcomes

Primary

Measure	Time frame
Development of a clinical recurrence of the lesion at any time during the first year of follow-up, confirmed by histology where this was available	—

Secondary

Measure	Time frame
Adverse effects of using topical 5-FU 1% four times daily for one month.	—

Countries

Kenya

Contacts

Public ContactStephen Gichuhi

Senior Lecturer & Consultant Ophthalmologist

sgichuhi@uonbi.ac.ke+2540-722873059

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026