Pediatric Zylet Safety and Efficacy Study (NCT00420628) | Clinical Trial Compass
CompletedPhase 4
Pediatric Zylet Safety and Efficacy Study
United States108 participantsStarted 2006-11
Plain-language summary
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)
Who can participate
Age range6 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Child, 0 to 6 years of age, any sex and race
* Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated
* In good health (no current or past relevant medical history), based on the judgment of the investigator
* Parent/guardian is able and willing to follow instructions and provide informed consent
Exclusion Criteria:
* Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication
* Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication
* Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study
* Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study
* Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration
* Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study
* History of ocular surgery, including laser procedures, within the past six months
* Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study
* Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacter…