Conditions: Conjunctivitis
Keywords: Blepharokeratoconjunctivitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 137
Healthy volunteers: no

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:

Arms:
arm 1: Drug: Zylet (loteprednol etabonate and tobramycin) arm 2: Drug: Lotemax (loteprednol etabonate) arm 3: Drug: Tobramycin arm 4: Vehicle of Zylet

Interventions: intervention 1: loteprednol etabonate and tobramycin intervention 2: loteprednol etabonate intervention 3: Tobramycin intervention 4: Vehicle of Zylet
Intervention descriptions: intervention 1: Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days. intervention 2: Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days. intervention 3: Topical ocular administration of Tobramycin QID for 14 days. intervention 4: Topical ocular administration of the vehicle of Zylet QID for 14 days.

Protocol document: