Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study

NCT02025023 | Recruiting Phase 3 FDA Drug

• 1 other identifier: STUDY00003748
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Size; Pain; Resolution; Complications; Swelling

Outcome Measures

Primary Outcomes (1)

• Size of chalazion

  4 weeks

Study Arms (4)

Incision and Curettage

ACTIVE COMPARATOR

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

Procedure: Incision and Curettage

Injection of Triamcinolone Acetonide

ACTIVE COMPARATOR

0.1 ml of triamcinolone is injected directly in the chalazion.

Drug: Triamcinolone Acetonide; Procedure: Incision and Curettage

Injection of 5-fluorouracil

ACTIVE COMPARATOR

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

Drug: 5-fluorouracil Injection; Procedure: Incision and Curettage

Injection of triamcinolone/5FU mixture

ACTIVE COMPARATOR

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

Procedure: Incision and Curettage; Drug: Triamcinolone Acetonide/5-fluorouracil mixture

Interventions

5-fluorouracil Injection DRUG

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

Also known as: 5-FU

Injection of 5-fluorouracil

Triamcinolone Acetonide DRUG

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

Also known as: triamcinolone

Injection of Triamcinolone Acetonide

Incision and Curettage PROCEDURE

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.

Incision and Curettage; Injection of 5-fluorouracil; Injection of Triamcinolone Acetonide; Injection of triamcinolone/5FU mixture

Triamcinolone Acetonide/5-fluorouracil mixture DRUG

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

Injection of triamcinolone/5FU mixture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single or multiple chalazia in a single eyelid

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Eye Institute at Harborview

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Chalazion; Pain

Interventions

Fluorouracil; Triamcinolone Acetonide; Triamcinolone; Curettage

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Eyelid Diseases; Eye Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Surgical Procedures, Operative

Study Officials

• Matthew M Zhang, MD

  University of Washington Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Vuletic

CONTACT

206-520-9728; simona@uw.edu

Ian Luttrell

CONTACT

206-520-8305; lutri@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: December 31, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

US (1)