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

February 4, 2020 updated by: Matthew Zhang, University of Washington
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomized interventional study comparing four current standard-of-care treatments for chalazia: incision and curettage, local injection of triamcinolone, local injection of 5-FU, and local injection of combination triamcinolone/5-FU.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Simona Vuletic
  • Phone Number: 206-520-9728
  • Email: simona@uw.edu

Study Contact Backup

  • Name: Ian Luttrell
  • Phone Number: 206-520-8305
  • Email: lutri@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington Eye Institute at Harborview
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.
Active Comparator: Injection of Triamcinolone Acetonide
0.1 ml of triamcinolone is injected directly in the chalazion.
Procedure: 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.
Drug: Triamcinolone Acetonide
If chalazion present at follow-up, another Triamcinolone injection will be done.
Other Names:
  • triamcinolone
Active Comparator: Injection of 5-fluorouracil
0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.
Procedure: 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.
Drug: 5-fluorouracil Injection
If the chalazion is present at follow-up visit, another injection of 5-FU will be given.
Other Names:
  • 5-FU
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.
Procedure: 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.
Drug: Triamcinolone Acetonide/5-fluorouracil mixture
If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Size of chalazion
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Matthew M Zhang, MD, University of Washington Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

December 29, 2013

First Submitted That Met QC Criteria

December 29, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003748

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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