NCT07496515

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The randomized clinical trial will address two primary questions: 1. Is treatment with anti-Demodex eyelid cleanser superior to standard eyelid cleanser for improvement or resolution of chalazia at 8 weeks? 2. Is treatment with omega-3 supplementation for one year superior to no omega-3 supplementation for one year for the prevention of new chalazia between 8 weeks and 12 months? In addition, parents will take standardized photographs of their children's eyelids twice - first after the enrollment visit and second before the 8-week visit. Photographs will be supplemented with a Parental Treatment Outcome Question and parental palpation of the eyelids before the 8-week visit. The objective is to evaluate the agreement between a masked central reader's review of telehealth information (parental photos and Parental Treatment Outcome Question) and an in-office clinical assessment by a masked investigator "'gold standard") when determining whether chalazia have improved/resolved (versus not) at 8 weeks, across all treatment groups. Treatment with warm compresses and one of two different eyelid cleansers is mandated in each group for the first 8 weeks of the study. Treatment between 8 weeks and 12 months is at investigator discretion; however, the omega-3 group must continue omega-3 supplementation through 12 months, and the anti-Demodex eyelid cleanser and standard eyelid cleanser groups must NOT receive any omega-3 supplementation. Development of new chalazia between 8 weeks and 12 months will be assessed at 6- and 12-month follow-up visits, as well as by querying parents with monthly text or email message reminders and monthly online surveys. "New chalazion" is defined as a new lesion developing in the same location as a previously resolved chalazion or in a new area on any eyelid.

Conditions

• Pediatric Chalazia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-08-01
• Completion: 2028-02-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Regulatory

• FDA-regulated drug study