Status:
COMPLETED
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Conjunctivitis
Eligibility:
All Genders
1-6 years
Phase:
PHASE4
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 pediatri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00705159
Start Date
June 1 2008
End Date
May 1 2010
Last Update
March 24 2015
Active Locations (1)
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1
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States, 16501