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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
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.
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.
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States
Treatment Emergent Adverse Events
Study eye - Safety Population, At all visits 1,2,3
Time frame: day 1, day 8, day 15
Investigators Global Assessment of the Clinical Condition
The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened.
Time frame: Visit 3, day 8
Assessment of Ocular Signs in the Study Eye - Visit 1
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time frame: Visit 1 (day 1)
Assessment of Ocular Signs in the Study Eye - Visit 2
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time frame: Visit 2 (day 8)
Assessment of Ocular Signs in the Study Eye - Visit 3
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time frame: Visit 3 (day 15)
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