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NOT YET RECRUITING
NCT07496515
PHASE2

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

Sponsor: Jaeb Center for Health Research

View on ClinicalTrials.gov

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.

Official title: A Randomized Trial of Omega-3 Dietary Supplementation, Anti Demodex Eyelid Cleanser, and Standard Eyelid Cleanser for Pediatric Chalazia

Key Details

Gender

All

Age Range

4 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2026-06-01

Completion Date

2028-02-01

Last Updated

2026-03-27

Healthy Volunteers

No

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)