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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-05-31

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.

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Detailed Description

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Conditions

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Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Loteprednol etabonate and tobramycin

Drug: Zylet (loteprednol etabonate and tobramycin)

Group Type EXPERIMENTAL

loteprednol etabonate and tobramycin

Intervention Type DRUG

Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.

Loteprednol etabonate

Drug: Lotemax (loteprednol etabonate)

Group Type ACTIVE_COMPARATOR

loteprednol etabonate

Intervention Type DRUG

Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.

Tobramycin

Drug: Tobramycin

Group Type ACTIVE_COMPARATOR

Tobramycin

Intervention Type DRUG

Topical ocular administration of Tobramycin QID for 14 days.

Vehicle

Vehicle of Zylet

Group Type PLACEBO_COMPARATOR

Vehicle of Zylet

Intervention Type DRUG

Topical ocular administration of the vehicle of Zylet QID for 14 days.

Interventions

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loteprednol etabonate and tobramycin

Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.

Intervention Type DRUG

loteprednol etabonate

Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.

Intervention Type DRUG

Tobramycin

Topical ocular administration of Tobramycin QID for 14 days.

Intervention Type DRUG

Vehicle of Zylet

Topical ocular administration of the vehicle of Zylet QID for 14 days.

Intervention Type DRUG

Other Intervention Names

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Zylet Lotemax

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.

Minimum Eligible Age

1 Week

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No