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

NCT07496515 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CH01
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pediatric Chalazia

Keywords

pediatric; chalazia

Outcome Measures

Primary Outcomes (2)

• Anti-Demodex vs Standard Cleanser

  The primary efficacy outcome will be the proportion of participants whose chalazia are determined to be "improved or resolved" vs. "worse or unchanged" after 8 weeks, based on a masked investigator examination.

  8 weeks

• Omega-3 vs Standard

  The primary efficacy outcome will be the proportion of participants with development of new chalazia between 8 weeks to 12 months based on all available data.

  12 months

Study Arms (3)

OMEGA-3 Group

EXPERIMENTAL

1x daily oral Omega-3 supplementation, plus 2x daily warm compresses and standard lid cleanser

Dietary Supplement: Omega-3 supplement; Device: Warm compress; Device: Standard eyelid cleanser

ANTI-DEMODEX Group

EXPERIMENTAL

2x daily warm compresses and anti-Demodex lid cleanser

Device: Warm compress; Drug: Anti-Demodex eyelid cleanser

STANDARD Group

PLACEBO COMPARATOR

2x daily warm compresses and standard lid cleanser

Device: Warm compress; Device: Standard eyelid cleanser

Interventions

Omega-3 supplement DIETARY_SUPPLEMENT

Oral omega-3 supplementation (eicosapentaenoic acid and docosahexaenoic acid) - once daily dose of 5mL (1000mg) or 10mL (2000 mg total), depending on age and weight

OMEGA-3 Group

Warm compress DEVICE

Twice daily warm compresses (using a Bruder® Mask)

ANTI-DEMODEX Group; OMEGA-3 Group; STANDARD Group

Standard eyelid cleanser DEVICE

Twice daily standard eyelid cleanser (OCuSOFT® eyelid Scrub Plus Pre-Moistened Pads)

OMEGA-3 Group; STANDARD Group

Anti-Demodex eyelid cleanser DRUG

Twice daily anti-Demodex eyelid cleanser (Cliradex® Towelettes)

ANTI-DEMODEX Group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead

MeSH Terms

Conditions

Chalazion

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Eyelid Diseases; Eye Diseases

Study Officials

• Amy L Waters, OD, FAAO

  Children's Mercy Hospital and Clinics

  STUDY CHAIR

• Courtney L Kraus, MD

  Wilmer Eye Institute

  STUDY CHAIR

Central Study Contacts

Danielle L Chandler, MSPH

CONTACT

813-975-8690; dchandler@jaeb.org

Raymond T Kraker, MSPH

CONTACT

813-975-8690; rkraker@jaeb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF