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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT02025023
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chalazion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-fluorouracil Injection — DRUG
    If the chalazion is present at follow-up visit, another injection of 5-FU will be given.
  • Triamcinolone Acetonide — DRUG
    If chalazion present at follow-up, another Triamcinolone injection will be done.
  • 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.
  • Triamcinolone Acetonide/5-fluorouracil mixture — DRUG
    If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.

Study Details

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.

Key Dates

Start date
Dec 31, 2013
Status verified
Feb 2020
Primary completion
Jul 31, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Size of chalazion [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Eye Institute at HarborviewSeattleWashington98104
Simona Vuletic
[email protected]
206-520-9728

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By research site
University of Washington Eye Institute at Harborview· Seattle, WA

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