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OpenTrials
Completed

NCT Number: NCT00705159

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

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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Key information

Conditions

Conjunctivitis Conjunctival Diseases Eye Diseases

Age range

1 week–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, 16501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

loteprednol etabonate and tobramycin

Drug

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

Other names: Zylet

Loteprednol Etabonate

Drug

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

Other names: Lotemax

Tobramycin

Drug

Topical ocular administration of Tobramycin QID for 14 days.

Vehicle of Zylet

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2008
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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