Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia

Starting soon · Phase 2

Conditions studied: Pediatric Chalazia

In brief

Participants enrolled into the study will be prescribed twice daily warm compresses for 8 weeks and randomly allocated (1:1:1) to receive either 1) Oral omega-3 supplementation and standard eyelid cleanser, 2) Anti-Demodex eyelid cleanser, or 3) Standard eyelid cleanser as treatment for chalazia. Participants will return for a visit after 8 weeks for a masked clinical exam to determine whether the chalazia has improved or resolved. The 8-week visit will also include a masked central reader's assessment of parent photographs, parental palpation of eyelids, and review of Parental Treatment Outcome Question as part of a telehealth objective. After the 8-week visit, treatment is at investigator discretion other than 1) the OMEGA-3 group must continue the study-prescribed omega-3 supplementation and 2) the ANTI-DEMODEX and STANDARD groups must not receive omega-3 supplementation. Participants will be followed from 8 weeks to 12 months from baseline to determine the proportion of participants with new chalazia based on monthly parental report and office visits at 6 months and 12 months.

Key facts

Study ID

NCT07496515

Run by

Jaeb Center for Health Research

People needed

168

Starts

2026-10-01

Expected to finish

2028-02-01

Last updated by the study team

2026-07-22

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.