A Phase 2 interventional study of Omega-3 supplement and Warm compress in Pediatric Chalazia, sponsored by Jaeb Center for Health Research. Not yet recruiting. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Jaeb Center for Health Research · Phase 2, Interventional, and Treatment
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.
The randomized clinical trial will address two primary questions:
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.
Jaeb Center for Health Research is the lead sponsor of 129 studies on the registry; 16 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnosis of any of the following conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
2x daily warm compresses and anti-Demodex lid cleanser
Device: Warm compress · Drug: Anti-Demodex eyelid cleanser
2x daily warm compresses and standard lid cleanser
Device: Warm compress · Device: Standard eyelid cleanser
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
Twice daily warm compresses (using a Bruder® Mask)
Twice daily standard eyelid cleanser (OCuSOFT® eyelid Scrub Plus Pre-Moistened Pads)
Twice daily anti-Demodex eyelid cleanser (Cliradex® Towelettes)
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.
Time frame: 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.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Chalazion
Jaeb Center for Health Research →