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

Conjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705159
• Other study ID #: 550
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2008
• Last updated: March 4, 2015
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: March 2015
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis

Intervention

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

Locations

Country	Name	City	State
United States	Pediatric Ophthalmology of Erie	Erie	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 15 days	No
Secondary	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.	Baseline to Day 3	No
Secondary	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.	Baseline to Day 7	No