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NCT07496515: CH01

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

Not yet recruiting Phase 2 Last updated 27 March 2026
What this trial tests

Phase 2 trial testing Omega-3 supplement in Pediatric Chalazia in 168 participants. Not yet recruiting.

Timeline
1 June 2026
Primary endpoint
1 August 2026
1 February 2028

Quick facts

Lead sponsorJaeb Center for Health Research
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment168
Start date1 June 2026
Primary completion1 August 2026
Estimated completion1 February 2028

Drugs / interventions tested

Conditions studied

Sponsor

Jaeb Center for Health Research — full company profile →

Who can join

Adults 4 to 17, any sex, with Pediatric Chalazia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Omega-3 supplement

Trials testing the same drug.

Other Jaeb Center for Health Research trials

Trials by the same sponsor.

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Data sources for this page

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