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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2010

Interventions

  • Drug: loteprednol etabonate and tobramycin
    • Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
  • Drug: loteprednol etabonate
    • Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
  • Drug: Tobramycin
    • Topical ocular administration of Tobramycin QID for 14 days.
  • Drug: Vehicle of Zylet
    • Topical ocular administration of the vehicle of Zylet QID for 14 days.

Arms, Groups and Cohorts

  • Experimental: Loteprednol etabonate and tobramycin
    • Drug: Zylet (loteprednol etabonate and tobramycin)
  • Active Comparator: Loteprednol etabonate
    • Drug: Lotemax (loteprednol etabonate)
  • Active Comparator: Tobramycin
    • Drug: Tobramycin
  • Placebo Comparator: Vehicle
    • Vehicle of Zylet

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in the Total Blepharoconjunctivitis Grade.
    • Time Frame: Baseline to 15 days
    • 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.

Secondary Measures

  • Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
    • Time Frame: Baseline to Day 3
    • 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.
  • Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
    • Time Frame: Baseline to Day 7
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Week

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor

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