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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  06/03/2010
 
Trade Name:  Zylet
 
Generic or Proper Name (*):  loteprednol etabonate and tobramycin
 
Indications Studied:  Eye lid inflammation
 
Therapeutic Category:  Anti-inflammatory, Antibiotic
 
Ages Studied:  0 - 6 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo
 
No Patients:  108
 
No Centers:  15
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
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