Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.

Official Title
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Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

Conditions
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Conjunctivitis

Intervention / Treatment
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* Drug: loteprednol etabonate and tobramycin
* Drug: loteprednol etabonate
* Drug: Tobramycin
* Drug: Vehicle of Zylet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children 0-6 years of age. clinical diagnosis of blepharoconjunctivitis Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures. Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization. Exclusion Criteria: Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication. Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months. Subjects who are monocular. Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study. Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.

Ages Eligible for Study
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Minimum Age: 1 Week
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 etabonate and tobramycin<br>Drug: Zylet (loteprednol etabonate and tobramycin) | Drug: loteprednol etabonate and tobramycin<br>* Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.<br>* Other names: Zylet;|
| Active Comparator: Loteprednol etabonate<br>Drug: Lotemax (loteprednol etabonate) | Drug: loteprednol etabonate<br>* Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.<br>* Other names: Lotemax;|
| Active Comparator: Tobramycin<br>Drug: Tobramycin | Drug: Tobramycin<br>* Topical ocular administration of Tobramycin QID for 14 days.<br>|
| Placebo Comparator: Vehicle<br>Vehicle of Zylet | Drug: Vehicle of Zylet<br>* Topical ocular administration of the vehicle of Zylet QID for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Total Blepharoconjunctivitis Grade. | Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. | Baseline to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2 | Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. | Baseline to Day 3 | 
| Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 | Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. | Baseline to Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharokeratoconjunctivitis