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

Primary Purpose

Conjunctivitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
loteprednol etabonate and tobramycin
loteprednol etabonate
Tobramycin
Vehicle of Zylet
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conjunctivitis focused on measuring Blepharokeratoconjunctivitis

Eligibility Criteria

1 Week - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Pediatric Ophthalmology of Erie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Loteprednol etabonate and tobramycin

Loteprednol etabonate

Tobramycin

Vehicle

Arm Description

Drug: Zylet (loteprednol etabonate and tobramycin)

Drug: Lotemax (loteprednol etabonate)

Drug: Tobramycin

Vehicle of Zylet

Outcomes

Primary Outcome Measures

Change From Baseline in the Total Blepharoconjunctivitis Grade.
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
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
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.

Full Information

First Posted
June 20, 2008
Last Updated
March 4, 2015
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00705159
Brief Title
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Official Title
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis
Keywords
Blepharokeratoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loteprednol etabonate and tobramycin
Arm Type
Experimental
Arm Description
Drug: Zylet (loteprednol etabonate and tobramycin)
Arm Title
Loteprednol etabonate
Arm Type
Active Comparator
Arm Description
Drug: Lotemax (loteprednol etabonate)
Arm Title
Tobramycin
Arm Type
Active Comparator
Arm Description
Drug: Tobramycin
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle of Zylet
Intervention Type
Drug
Intervention Name(s)
loteprednol etabonate and tobramycin
Other Intervention Name(s)
Zylet
Intervention Description
Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
Intervention Type
Drug
Intervention Name(s)
loteprednol etabonate
Other Intervention Name(s)
Lotemax
Intervention Description
Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
Intervention Type
Drug
Intervention Name(s)
Tobramycin
Intervention Description
Topical ocular administration of Tobramycin QID for 14 days.
Intervention Type
Drug
Intervention Name(s)
Vehicle of Zylet
Intervention Description
Topical ocular administration of the vehicle of Zylet QID for 14 days.
Primary Outcome Measure Information:
Title
Change From Baseline in the Total Blepharoconjunctivitis Grade.
Description
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.
Time Frame
Baseline to 15 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
Description
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.
Time Frame
Baseline to Day 3
Title
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
Description
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.
Time Frame
Baseline to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Pediatric Ophthalmology of Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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