Pediatric Zylet Safety and Efficacy Study

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Chalazion, Hordeolum

Intervention / Treatment
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* Drug: loteprednol etabonate/tobramycin opthalmic suspension
* Drug: vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol/Tobramycin<br>0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension | Drug: loteprednol etabonate/tobramycin opthalmic suspension<br>* Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.<br>* Other names: Zylet;|
| Placebo Comparator: Vehicle<br>Vehicle | Drug: vehicle<br>* topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events | Study eye - Safety Population, At all visits 1,2,3 | day 1, day 8, day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators Global Assessment of the Clinical Condition | The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened. | Visit 3, day 8 | 
| Assessment of Ocular Signs in the Study Eye - Visit 1 | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. | Visit 1 (day 1) | 
| Assessment of Ocular Signs in the Study Eye - Visit 2 | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. | Visit 2 (day 8) | 
| Assessment of Ocular Signs in the Study Eye - Visit 3 | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. | Visit 3 (day 15) |