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

Prior treatment

• Use of oral antibiotics or oral steroids within the prior 2 weeks.
• Current or prior use of implanted steroids.
• Prior surgery or injection for chalazia on any eyelid within the previous 6 months.
• Daily use of non-steroidal anti-inflammatory (NSAID) or blood-pressure-lowering medications.
• Current chemotherapy treatment.
• Current use of any other medication that the investigator feels may significantly interact with omega 3 supplementation, not including oral contraceptives.
• Has previously been randomized as a participant in this study.

Other illness

• 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 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
• Known hypersensitivity or allergy of fish or seafood.
• Known hypersensitivity or allergy to oral omega-3 supplements
• Bleeding disorder or taking any anticoagulants/antiplatelet medications.
• Diagnosis of any of the following conditions:
  • diabetes mellitus
  • heart rhythm disorder
  • underactive thyroid
  • liver disease
  • pancreatic disease

Other

• 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 anti-Demodex treatment in the last 2 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.
• Intraocular inflammation of any kind within the last month.
• Ocular rosacea.
• Unable to consume liquid supplements orally.
• Consumption of fish 4 or more times a week (on average).
• Current use of orlistat (Xenical or Alli).
• 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.
• 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.

• 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.