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

Study acronym: CH01
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 1, 2026 → Dec 1, 2026
See other at-risk trials from Jaeb Center for Health Research

Record History

  1. 2 versions Re-verified since Aug 20, 2026, no change to tracked fieldsv3-v4
  2. Start date: Jun 1, 2026 to Oct 1, 2026
    • Primary completion pushed from Aug 1, 2026 to Dec 1, 2026
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07496515
Lead Sponsor Jaeb Center for Health Research
Conditions
(from sponsor)		 Pediatric Chalazia
Related terms Chalazion
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov