Conditions: Chalazion Hordeolum
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 108
Healthy volunteers: no

Brief summary:
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)

Detailed description:

Arms:
arm 1: 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension arm 2: Vehicle

Interventions: intervention 1: loteprednol etabonate/tobramycin opthalmic suspension intervention 2: vehicle
Intervention descriptions: intervention 1: Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication. intervention 2: topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.

Protocol document: