Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia (CH01)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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.
- 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.
Exclusion criteria
-
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.
-
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 design
Primary purpose
Allocation
Interventional model
Masking
168 participants in 3 patient groups, including a placebo group
Trial contacts and locations
Loading...
Central trial contact
Raymond T Kraker, MSPH; Danielle L Chandler, MSPH
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal