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Fish oil and eyelid wipes: a new hope for Kids' stubborn styes?

NCT ID NCT07496515

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 26, 2026 · Updated 6 times

Summary

This study tests whether omega-3 supplements or a special anti-demodex eyelid cleanser can help treat and prevent chalazia (styes) in children aged 4 to 17. All 168 participants will use warm compresses, and they will be split into three groups: one adds omega-3 fish oil and standard eyelid wipes, another uses anti-demodex wipes, and the third uses standard wipes only. The goal is to see which approach works best for clearing current styes and stopping new ones over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Omega-3 supplement (fish oil) and anti-demodex eyelid cleanser
What this could lead to
If it works, this could offer simple, non-surgical ways to treat and prevent chalazia in children, reducing the need for procedures.
What could go wrong
This is a small Phase 2 trial, so results may not be conclusive. The treatments might not work better than standard warm compresses and eyelid cleansers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 168 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 4 to \<17.0 years. * At least one chalazion measuring \>3 mm, visible without special instrumentation. * Chalazion onset (all current lesions) within the past 6 months by parental report. * Willing to forego non-study use of omega-3 supplements (i.e., pills, liquid, gummies) for the duration of the study. * Prior or current treatment with warm compresses, eyelid cleanser/scrubs, topical antibiotic, and/or topical steroids IS allowed. * Topical antibiotics and topical steroids must be discontinued at study enrollment. * All non-study treatments for chalazia must be discontinued at enrollment for the first 8 weeks of the study. * Parent seeking treatment for child's chalazion/chalazia. * There is a working microwave oven/and refrigerator in the home. * Parent has a smartphone or other digital device that can take photographs. * Parent is able and willing to take photographs and upload them to the PEDIG website. * The parent and participant are willing to comply with the assigned treatment regimen after an in-office trial of Cliradex® and Physician Recommended Nutraceuticals (PRN)® Eye Omega Benefits for Kids * Willing to consume fish-based oral supplements. * Contact lens correction of refractive error is allowed. Exclusion Criteria: * Current chalazion on any eyelid present for over 6 months by parental report. * Use of oral omega-3 supplements (i.e., pills, liquid, gummies) in the last 2 months. * Use of oral antibiotics or oral steroids within the prior 2 weeks. * Use of anti-Demodex treatment in the last 2 months. * Current or prior use of implanted steroids. * Prior surgery or injection for chalazia on any eyelid within the previous 6 months. * Presence of ptosis as defined by 2-mm or smaller marginal light-reflex distance 1 (MRD-1) (distance from corneal light reflex and bottom of upper eyelid). This includes ptosis covering the visual axis. Sectoral mechanical ptosis in the area of chalazia is allowed if the visual axis is not obscured, and the investigator does not deem the ptosis visually significant. * History of ptosis surgery. * Any conjunctivitis (e.g., phlyctenular keratoconjunctivitis, allergic, bacterial, and/or vernal) requiring treatment other than antihistamines, artificial tears, and/or cold compresses. * Intraocular inflammation of any kind within the last month. * Intraocular conditions that in the investigator's opinion may require use of oral or intraocular steroids, or systemic immunotherapy within the next year. * Current corneal erosion, infiltrates, ulcers, significant neovascularization (within 3 mm of optical center), or history of corneal graft or central corneal scarring * Known hypersensitivity or allergy to Cliradex® Towelette ingredients including terpinen-4-ol, a tea tree oil derivative. * Known hypersensitivity or allergy to OCuSOFT® eyelid Scrub Plus Pre-Moistened Pads or its ingredients (Polyhexamethylene biguanide preservative (PHMB), provitamin B5, and decyl glucoside). * Known hypersensitivity or allergy to Bruder® mask * Ocular rosacea. * Known hypersensitivity or allergy of fish or seafood. * Known hypersensitivity or allergy to oral omega-3 supplements * Unable to consume liquid supplements orally. * Consumption of fish 4 or more times a week (on average). * Bleeding disorder or taking any anticoagulants/antiplatelet medications. * Daily use of non-steroidal anti-inflammatory (NSAID) or blood-pressure-lowering medications. * Current chemotherapy treatment. * Current use of orlistat (Xenical or Alli). * Current use of any other medication that the investigator feels may significantly interact with omega 3 supplementation, not including oral contraceptives. * Diagnosis of any of the following conditions: * diabetes mellitus * heart rhythm disorder * underactive thyroid * liver disease * pancreatic disease * Moving outside the area in the next 12 months. * Other family member participating in the study. * Immediate family member (i.e., parent or legal guardian, sibling) is an investigator, coordinator, or certified tester directly affiliated with this study or an employee of the JAEB Center for Health Research. * Has previously been randomized as a participant in this study. * Developmental delays/sensory sensitivities that parents or the investigator feel would interfere with study treatment. * Pregnancy, lactating or planning on becoming pregnant during study participation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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