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

Bausch + Lomb

Status and phase: Completed; Phase 4

Conditions: Conjunctivitis

Treatments: Drug: Vehicle of Zylet; Drug: loteprednol etabonate and tobramycin; Drug: loteprednol etabonate; Drug: Tobramycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00705159

550

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 1 week to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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137 participants in 4 patient groups, including a placebo group

Loteprednol etabonate and tobramycin

Experimental group

Description:

Drug: Zylet (loteprednol etabonate and tobramycin)

Treatment:

Drug: loteprednol etabonate and tobramycin

Loteprednol etabonate

Active Comparator group

Description:

Drug: Lotemax (loteprednol etabonate)

Treatment:

Drug: loteprednol etabonate

Tobramycin

Active Comparator group

Description:

Drug: Tobramycin

Treatment:

Drug: Tobramycin

Vehicle

Placebo Comparator group

Description:

Vehicle of Zylet

Treatment:

Drug: Vehicle of Zylet