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

ConditionPediatric Chalazia

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age4-17

SponsorJaeb Center for Health Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 4 to <17.0 years.

At least one chalazion measuring >3 mm, visible without special instrumentation.

Chalazion onset (all current lesions) within the past 6 months by parental report.

Willing to forego non-study use of omega-3 supplements (i.e., pills, liquid, gummies) for the duration of the study.

Disqualifiers

Current chalazion on any eyelid present for over 6 months by parental report.

Use of oral omega-3 supplements (i.e., pills, liquid, gummies) in the last 2 months.

Use of oral antibiotics or oral steroids within the prior 2 weeks.

Use of anti-Demodex treatment in the last 2 months.

Trial design

Design model

Parallel

Treatments tested in this trial

Omega-3 supplement
Dietary 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
Warm compress
Device
Twice daily warm compresses (using a Bruder® Mask)
Standard eyelid cleanser
Device
Twice daily standard eyelid cleanser (OCuSOFT® eyelid Scrub Plus Pre-Moistened Pads)
Anti-Demodex eyelid cleanser
Drug
Twice daily anti-Demodex eyelid cleanser (Cliradex® Towelettes)

Treatment groups

168 Participants

are divided into 3 treatment groups

Group A: OMEGA-3 GroupExperimental treatment 3 interventions

Group B: ANTI-DEMODEX GroupExperimental treatment 2 interventions

Group C: STANDARD GroupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jaeb Center for Health Research

Lead sponsor

Source ClinicalTrials.gov

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