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
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
Treatments tested in this trial
- Omega-3 supplement
- Warm compress
- Standard eyelid cleanser
- Anti-Demodex eyelid cleanser
Treatment groups
168 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov