Recruiting
Phase 3

5-Fluorouracil

Sponsor:

University of Washington

Code:

NCT02025023

Conditions

Chalazion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

5-fluorouracil Injection

Triamcinolone Acetonide

Incision and Curettage

Triamcinolone Acetonide/5-fluorouracil mixture

Study Details

Brief summary:

Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection of triamcinolone (steroid) and incision and curettage for treatment of chalazia.

Conditions

Chalazion

Study ID

NCT02025023

Start date

Dec, 2013

Status verified date

Feb, 2020

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Single or multiple chalazia in a single eyelid

Exclusion Criteria:

  • Chalazia present for less than one month and no previous injection or incision and curettage

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Incision and Curettage

A vertical incision over the area of chalazion will be done. Inflammatory material will be removed and the chalazion capsule will be excised.

active comparator: Injection of Triamcinolone Acetonide

0.1 ml of triamcinolone is injected directly in the chalazion.

active comparator: Injection of 5-fluorouracil

0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.

active comparator: Injection of triamcinolone/5FU mixture

0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.

Interventions

5-fluorouracil Injection

If the chalazion is present at follow-up visit, another injection of 5-FU will be given.

Triamcinolone Acetonide

If chalazion present at follow-up, another Triamcinolone injection will be done.

Incision and Curettage

If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.

Triamcinolone Acetonide/5-fluorouracil mixture

If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.

Primary outcome measure

  • Size of chalazion [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Simona Vuletic

206-520-9728simona@uw.edu

Ian Luttrell

206-520-8305lutri@uw.edu

Locations

University of Washington Eye Institute at Harborview

Recruiting

Seattle, Washington, United States, 98104

Contacts

Simona Vuletic

206-520-9728simona@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Feb 6, 2020

Last verified

Feb, 2020

Keywords

  • Size
  • Pain
  • Resolution
  • Complications
  • Swelling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2020-02-06.