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

Primary Purpose

Chalazion

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
5-fluorouracil Injection
Triamcinolone Acetonide
Incision and Curettage
Triamcinolone Acetonide/5-fluorouracil mixture
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chalazion focused on measuring Size, Pain, Resolution, Complications, Swelling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington Eye Institute at HarborviewRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Incision and Curettage

Injection of Triamcinolone Acetonide

Injection of 5-fluorouracil

Injection of triamcinolone/5FU mixture

Arm Description

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

0.1 ml of triamcinolone is injected directly in the chalazion.

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

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

Outcomes

Primary Outcome Measures

Size of chalazion

Secondary Outcome Measures

Full Information

First Posted
December 29, 2013
Last Updated
February 4, 2020
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT02025023
Brief Title
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
Acronym
CTS
Official Title
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion
Keywords
Size, Pain, Resolution, Complications, Swelling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Incision and Curettage
Arm Type
Active Comparator
Arm Description
A vertical incision over the area of chalazion will be done. Inflammatory material will be removed and the chalazion capsule will be excised.
Arm Title
Injection of Triamcinolone Acetonide
Arm Type
Active Comparator
Arm Description
0.1 ml of triamcinolone is injected directly in the chalazion.
Arm Title
Injection of 5-fluorouracil
Arm Type
Active Comparator
Arm Description
0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.
Arm Title
Injection of triamcinolone/5FU mixture
Arm Type
Active Comparator
Arm Description
0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil Injection
Other Intervention Name(s)
5-FU
Intervention Description
If the chalazion is present at follow-up visit, another injection of 5-FU will be given.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
triamcinolone
Intervention Description
If chalazion present at follow-up, another Triamcinolone injection will be done.
Intervention Type
Procedure
Intervention Name(s)
Incision and Curettage
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide/5-fluorouracil mixture
Intervention Description
If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.
Primary Outcome Measure Information:
Title
Size of chalazion
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simona Vuletic
Phone
206-520-9728
Email
simona@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Luttrell
Phone
206-520-8305
Email
lutri@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew M Zhang, MD
Organizational Affiliation
University of Washington Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Eye Institute at Harborview
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Vuletic
Phone
206-520-9728
Email
simona@uw.edu

12. IPD Sharing Statement

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

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