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

NCT07496515 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-08-25

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Omega-3 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

DEVICE

Warm compress

Twice daily warm compresses (using a Bruder® Mask)

DEVICE

Standard eyelid cleanser

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

DRUG

Anti-Demodex eyelid cleanser

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

Sponsors & Collaborators

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Amy L Waters, OD, FAAO · Children's Mercy Hospital and Clinics

  • Courtney L Kraus, MD · Wilmer Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2026-12-01
Completion
2028-02-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07496515 on ClinicalTrials.gov