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

NCT00705159 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Bausch & Lomb Incorporated
Phase	Phase 4
Status	COMPLETED
Enrolment	137
Start date	2008-06
Completion	2010-05

Conditions

• Conjunctivitis

Interventions

• loteprednol etabonate and tobramycin
• loteprednol etabonate
• Tobramycin
• Vehicle of Zylet

Primary outcomes

• 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.

Countries

United States