Pediatric ChalaziaPhase 2CH01NCT07496515
Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia
A Phase 2 study testing Omega-3 supplement, Warm compress and Standard eyelid cleanser in people with Pediatric Chalazia, run by Jaeb Center for Health Research.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Pediatric Chalazia
- What is being tested?
- Omega-3 supplement, Warm compress and Standard eyelid cleanser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Prior or current treatment with warm compresses, eyelid cleanser/scrubs, topical antibiotic, and/or topical steroids IS allowed.
- Topical antibiotics and topical steroids must be discontinued at study enrollment.
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- All non-study treatments for chalazia must be discontinued at enrollment for the first 8 weeks of the study.
- Parent seeking treatment for child's chalazion/chalazia.
- There is a working microwave oven/and refrigerator in the home.
- Parent has a smartphone or other digital device that can take photographs.
- Parent is able and willing to take photographs and upload them to the PEDIG website.
- The parent and participant are willing to comply with the assigned treatment regimen after an in-office trial of Cliradex® and Physician Recommended Nutraceuticals (PRN)® Eye Omega Benefits for Kids
- Willing to consume fish-based oral supplements.
- Contact lens correction of refractive error is allowed.
Who cannot join
- 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.
- Current or prior use of implanted steroids.
- Prior surgery or injection for chalazia on any eyelid within the previous 6 months.
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- Presence of ptosis as defined by 2-mm or smaller marginal light-reflex distance 1 (MRD-1) (distance from corneal light reflex and bottom of upper eyelid). This includes ptosis covering the visual axis. Sectoral mechanical ptosis in the area of chalazia is allowed if the visual axis is not obscured, and the investigator does not deem the ptosis visually significant.
- History of ptosis surgery.
- Any conjunctivitis (e.g., phlyctenular keratoconjunctivitis, allergic, bacterial, and/or vernal) requiring treatment other than antihistamines, artificial tears, and/or cold compresses.
- Intraocular inflammation of any kind within the last month.
- Intraocular conditions that in the investigator's opinion may require use of oral or intraocular steroids, or systemic immunotherapy within the next year.
- Current corneal erosion, infiltrates, ulcers, significant neovascularization (within 3 mm of optical center), or history of corneal graft or central corneal scarring
- Known hypersensitivity or allergy to Cliradex® Towelette ingredients including terpinen-4-ol, a tea tree oil derivative.
- Known hypersensitivity or allergy to OCuSOFT® eyelid Scrub Plus Pre-Moistened Pads or its ingredients (Polyhexamethylene biguanide preservative (PHMB), provitamin B5, and decyl glucoside).
- Known hypersensitivity or allergy to Bruder® mask
- Ocular rosacea.
- Known hypersensitivity or allergy of fish or seafood.
- Known hypersensitivity or allergy to oral omega-3 supplements
- Unable to consume liquid supplements orally.
- Consumption of fish 4 or more times a week (on average).
- Bleeding disorder or taking any anticoagulants/antiplatelet medications.
- Daily use of non-steroidal anti-inflammatory (NSAID) or blood-pressure-lowering medications.
- Current chemotherapy treatment.
- Current use of orlistat (Xenical or Alli).
- Current use of any other medication that the investigator feels may significantly interact with omega 3 supplementation, not including oral contraceptives.
- Diagnosis of any of the following conditions:
- diabetes mellitus
- heart rhythm disorder
- underactive thyroid
- liver disease
- pancreatic disease
- Moving outside the area in the next 12 months.
- Other family member participating in the study.
- Immediate family member (i.e., parent or legal guardian, sibling) is an investigator, coordinator, or certified tester directly affiliated with this study or an employee of the JAEB Center for Health Research.
- Has previously been randomized as a participant in this study.
- Developmental delays/sensory sensitivities that parents or the investigator feel would interfere with study treatment.
- Pregnancy, lactating or planning on becoming pregnant during study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Trial of Omega-3 Dietary Supplementation, Anti Demodex Eyelid Cleanser, and Standard Eyelid Cleanser for Pediatric Chalazia
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.
Read more
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.
Read the detailed description
The randomized clinical trial will address two primary questions:
- Is treatment with anti-Demodex eyelid cleanser superior to standard eyelid cleanser for improvement or resolution of chalazia at 8 weeks?
- Is treatment with omega-3 supplementation for one year superior to no omega-3 supplementation for one year for the prevention of new chalazia between 8 weeks and 12 months?
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.
- Conditions
- Pediatric Chalazia
- Being tested
- Omega-3 supplement, Warm compress, Standard eyelid cleanser, Anti-Demodex eyelid cleanser
- Keywords
- pediatric, chalazia
- Medical subject headings
- Chalazion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 supplementDietary 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 compressDevice
Twice daily warm compresses (using a Bruder® Mask)
Standard eyelid cleanserDevice
Twice daily standard eyelid cleanser (OCuSOFT® eyelid Scrub Plus Pre-Moistened Pads)
Anti-Demodex eyelid cleanserDrug
Twice daily anti-Demodex eyelid cleanser (Cliradex® Towelettes)
| Study group | Role | What they receive |
|---|---|---|
| OMEGA-3 Group | Experimental | 1x daily oral Omega-3 supplementation, plus 2x daily warm compresses and standard lid cleanser Receives: Dietary Supplement: Omega-3 supplement; Device: Warm compress; Device: Standard eyelid cleanser |
| ANTI-DEMODEX Group | Experimental | 2x daily warm compresses and anti-Demodex lid cleanser Receives: Device: Warm compress; Drug: Anti-Demodex eyelid cleanser |
| STANDARD Group | Placebo comparator | 2x daily warm compresses and standard lid cleanser Receives: Device: Warm compress; Device: Standard eyelid cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ChalaziaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy L Waters, OD, FAAO, Study chair, Children's Mercy Hospital and ClinicsCourtney L Kraus, MD, Study chair, Wilmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496515
- Sponsor's protocol ID
- CH01
- Acronym
- CH01
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Omega-3 Dietary Supplementation, Anti Demodex Eyelid Cleanser, and Standard Eyelid Cleanser for Pediatric Chalazia
- ClinicalTrials.gov ID
- NCT07496515
- Acronym / sponsor ID
- CH01 / CH01
- Conditions
- Pediatric Chalazia
- Keywords
- pediatric, chalazia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The randomized clinical trial will address two primary questions:
- Is treatment with anti-Demodex eyelid cleanser superior to standard eyelid cleanser for improvement or resolution of chalazia at 8 weeks?
- Is treatment with omega-3 supplementation for one year superior to no omega-3 supplementation for one year for the prevention of new chalazia between 8 weeks and 12 months?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OMEGA-3 Group | Experimental | Dietary Supplement: Omega-3 supplement, Device: Warm compress, Device: Standard eyelid cleanser1x daily oral Omega-3 supplementation, plus 2x daily warm compresses and standard lid cleanser |
| ANTI-DEMODEX Group | Experimental | Device: Warm compress, Drug: Anti-Demodex eyelid cleanser2x daily warm compresses and anti-Demodex lid cleanser |
| STANDARD Group | Placebo comparator | Device: Warm compress, Device: Standard eyelid cleanser2x daily warm compresses and standard lid cleanser |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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.
- Prior or current treatment with warm compresses, eyelid cleanser/scrubs, topical antibiotic, and/or topical steroids IS allowed.
Key exclusion criteria (37 listed)
- 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.
- Current or prior use of implanted steroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 supplementOral omega-3 supplementation (eicosapentaenoic acid and docosahexaenoic acid) - once daily dose of 5mL (1000mg) or 10mL (2000 mg total), depending on age and weight | Dietary supplement | OMEGA-3 Group |
| Warm compressTwice daily warm compresses (using a Bruder® Mask) | Device | ANTI-DEMODEX Group, OMEGA-3 Group, STANDARD Group |
| Standard eyelid cleanserTwice daily standard eyelid cleanser (OCuSOFT® eyelid Scrub Plus Pre-Moistened Pads) | Device | OMEGA-3 Group, STANDARD Group |
| Anti-Demodex eyelid cleanserTwice daily anti-Demodex eyelid cleanser (Cliradex® Towelettes) | Drug | ANTI-DEMODEX Group |
Primary outcome
Anti-Demodex vs Standard Cleanser
Time frame: 8 weeks
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.
Omega-3 vs Standard
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy L Waters, OD, FAAO study chair
Children's Mercy Hospital and Clinics
Courtney L Kraus, MD study chair
Wilmer Eye Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 supplement, Warm compress and Standard eyelid cleanser in people with Pediatric Chalazia, run by Jaeb Center for Health Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle L Chandler, MSPH (813-975-8690, dchandler@jaeb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Demodex vs Standard Cleanser (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.