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

Phase 4

Completed

• Conditions: Conjunctivitis
• Interventions: Drug: Tobramycin; Drug: Vehicle of Zylet; Drug: loteprednol etabonate and tobramycin; Drug: loteprednol etabonate

• Registration Number: NCT00705159
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Results First Submitted: 2011-06-14
• Results First Submitted QC: 2011-07-15
• Results First Posted: 2011-08-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tobramycin	Tobramycin	Drug: Tobramycin
Vehicle	Vehicle of Zylet	Vehicle of Zylet
Loteprednol etabonate and tobramycin	loteprednol etabonate and tobramycin	Drug: Zylet (loteprednol etabonate and tobramycin)
Loteprednol etabonate	loteprednol etabonate	Drug: Lotemax (loteprednol etabonate)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Total Blepharoconjunctivitis Grade.	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

Name	Time	Method
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2	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	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.

Trial Locations

Locations (1)

Pediatric Ophthalmology of Erie; 🇺🇸 Erie, Pennsylvania, United States