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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00705159
First Posted: June 25, 2008
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
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.

Condition Intervention Phase
Conjunctivitis Drug: loteprednol etabonate and tobramycin Drug: loteprednol etabonate Drug: Tobramycin Drug: Vehicle of Zylet Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome 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 Outcome 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.


Enrollment: 137
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Loteprednol etabonate and tobramycin
Drug: Zylet (loteprednol etabonate and tobramycin)
Drug: loteprednol etabonate and tobramycin
Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
Other Name: Zylet
Active Comparator: Loteprednol etabonate
Drug: Lotemax (loteprednol etabonate)
Drug: loteprednol etabonate
Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
Other Name: Lotemax
Active Comparator: Tobramycin
Drug: Tobramycin
Drug: Tobramycin
Topical ocular administration of Tobramycin QID for 14 days.
Placebo Comparator: Vehicle
Vehicle of Zylet
Drug: Vehicle of Zylet
Topical ocular administration of the vehicle of Zylet QID for 14 days.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705159


Locations
United States, Pennsylvania
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States, 16501
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00705159     History of Changes
Other Study ID Numbers: 550
First Submitted: June 20, 2008
First Posted: June 25, 2008
Results First Submitted: June 14, 2011
Results First Posted: August 11, 2011
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Bausch & Lomb Incorporated:
Blepharokeratoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Tobramycin
Loteprednol Etabonate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Allergic Agents