ChalazionPhase 3CTSNCT02025023
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
A Phase 3 study testing 5-fluorouracil Injection, Triamcinolone Acetonide and Incision and Curettage in people with Chalazion, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chalazion
- What is being tested?
- 5-fluorouracil Injection, Triamcinolone Acetonide and Incision and Curettage
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single or multiple chalazia in a single eyelid
Who cannot join
- Chalazia present for less than one month and no previous injection or incision and curettage
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Eye Institute at Harborview
Seattle, Washington, 98104
Simona Vuletic, 206-520-9728, simona@uw.edu
About this study
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.
Read the 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.
- Conditions
- Chalazion
- Being tested
- 5-fluorouracil Injection, Triamcinolone Acetonide, Incision and Curettage, Triamcinolone Acetonide/5-fluorouracil mixture
- Keywords
- Size, Pain, Resolution, Complications, Swelling
- Medical subject headings
- Chalazion, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracil InjectionDrug
Also called 5-FU
If the chalazion is present at follow-up visit, another injection of 5-FU will be given.
Triamcinolone AcetonideDrug
Also called triamcinolone
If chalazion present at follow-up, another Triamcinolone injection will be done.
Incision and CurettageProcedure or surgery
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 mixtureDrug
If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Incision and Curettage |
| Injection of Triamcinolone Acetonide | Active comparator | 0.1 ml of triamcinolone is injected directly in the chalazion. Receives: 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. Receives: 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. Receives: Procedure: Incision and Curettage; Drug: Triamcinolone Acetonide/5-fluorouracil mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of chalazion
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChalazionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Zhang, University of Washington
- Investigators
- Matthew M Zhang, MD, Principal investigator, University of Washington Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025023
- Sponsor's protocol ID
- STUDY00003748
- Acronym
- CTS
- Status last verified
- Feb 2020
- First submitted
- 29 Dec 2013
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
- ClinicalTrials.gov ID
- NCT02025023
- Acronym / sponsor ID
- CTS / STUDY00003748
- Conditions
- Chalazion
- Keywords
- Size, Pain, Resolution, Complications, Swelling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Incision and Curettage | Active comparator | Procedure: Incision and CurettageA vertical incision over the area of chalazion will be done. Inflammatory material will be removed and the chalazion capsule will be excised. |
| Injection of Triamcinolone Acetonide | Active comparator | Drug: Triamcinolone Acetonide, Procedure: Incision and Curettage0.1 ml of triamcinolone is injected directly in the chalazion. |
| Injection of 5-fluorouracil | Active comparator | Drug: 5-fluorouracil Injection, Procedure: Incision and Curettage0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally. |
| Injection of triamcinolone/5FU mixture | Active comparator | Procedure: Incision and Curettage, Drug: Triamcinolone Acetonide/5-fluorouracil mixture0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Single or multiple chalazia in a single eyelid
Key exclusion criteria (1 listed)
- Chalazia present for less than one month and no previous injection or incision and curettage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-fluorouracil InjectionAlso: 5-FUIf the chalazion is present at follow-up visit, another injection of 5-FU will be given. | Drug | Injection of 5-fluorouracil |
| Triamcinolone AcetonideAlso: triamcinoloneIf chalazion present at follow-up, another Triamcinolone injection will be done. | Drug | Injection of Triamcinolone Acetonide |
| Incision and CurettageIf chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture. | Procedure or surgery | Incision and Curettage, Injection of 5-fluorouracil, Injection of Triamcinolone Acetonide, Injection of triamcinolone/5FU mixture |
| Triamcinolone Acetonide/5-fluorouracil mixtureIf chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done. | Drug | Injection of triamcinolone/5FU mixture |
Primary outcome
Size of chalazion
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
Related trials for Chalazion
Not yet recruitingPhase 2
Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia
Pediatric Chalazia
Recruiting
Is the Use of a Steam Mask an Effective Treatment for Paediatric Chalazion in Comparison to Traditional Warm Compresses?
Chalazion
Not yet recruiting
Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
Chalazion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew M Zhang, MD principal investigator
University of Washington Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-fluorouracil Injection, Triamcinolone Acetonide and Incision and Curettage in people with Chalazion, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simona Vuletic (206-520-9728, simona@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of chalazion (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.