Clinical trial NCT00420628: Pediatric Zylet Safety and Efficacy Study
Official title: A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chalazion
Hordeolum
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 108
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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 bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication
* History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
* Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study
* Unlikely to comply with the protocol instructions for any reason

Primary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: day 1, day 8, day 15
Secondary outcomes:
measure: Investigators Global Assessment of the Clinical Condition
timeFrame: Visit 3, day 8
measure: Assessment of Ocular Signs in the Study Eye - Visit 1
timeFrame: Visit 1 (day 1)
measure: Assessment of Ocular Signs in the Study Eye - Visit 2
timeFrame: Visit 2 (day 8)
measure: Assessment of Ocular Signs in the Study Eye - Visit 3
timeFrame: Visit 3 (day 15)
Other outcomes:
Locations:
city: Erie
country: United States
facility: Pediatric Ophthalmology of Erie
state: Pennsylvania
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Timothy L Comstock, OD
role: STUDY_DIRECTOR
References: