PMID- 22292487
OWN - NLM
STAT- MEDLINE
DCOM- 20130329
LR  - 20211021
IS  - 1179-2019 (Electronic)
IS  - 1174-5878 (Linking)
VI  - 14
IP  - 2
DP  - 2012 Apr 1
TI  - Safety and tolerability of loteprednol etabonate 0.5% and tobramycin 0.3% 
      ophthalmic suspension in pediatric subjects.
PG  - 119-30
LID - 10.2165/11596320-000000000-00000 [doi]
AB  - BACKGROUND: Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension 
      (LE/T) is indicated for steroid-responsive inflammatory ocular conditions where 
      superficial bacterial ocular infection or a risk of bacterial ocular infection 
      exists. LE/T was shown to be safe in healthy volunteers and patients aged 18 
      years and older with minimal effect on intraocular pressure (IOP). OBJECTIVE: The 
      aim of the study was to evaluate the safety of LE/T in pediatric subjects by 
      examining data from two clinical studies. METHODS: Two randomized, multicenter, 
      double-masked, parallel-group (one two-arm, the other four-arm) studies were 
      conducted in subjects aged 0-6 years (N = 245). One study assessed LE/T compared 
      with vehicle in the management of lid inflammation (n = 108) and the other 
      compared LE/T with loteprednol etabonate ophthalmic suspension 0.5% (LE), 
      tobramycin ophthalmic solution 0.3% (tobramycin), and vehicle in the treatment of 
      blepharoconjunctivitis (n = 137). In the first study, subjects were randomized to 
      LE/T or vehicle administered four times daily (qid) for the first 7 days followed 
      by twice daily (bid) for 7 days along with warm compresses bid for the entire 2 
      weeks. In the second study, subjects were randomized to LE/T, LE, tobramycin, or 
      vehicle administered qid for 14 days. Treatment-emergent ocular and non-ocular 
      adverse events (AEs) and bilateral vision were assessed at all study visits in 
      both studies. In addition, in the lid inflammation study, IOP was assessed at all 
      visits. The primary safety endpoint in both studies was the incidence of 
      treatment-emergent AEs. RESULTS: The incidence of LE/T treatment-emergent AEs was 
      low. A total of four ocular AEs were reported for three LE/T-treated subjects in 
      the first study (conjunctivitis [two events], meibomian gland dysfunction, and 
      corneal staining), and one ocular AE was reported for an LE/T-treated subject in 
      the second study (eye pain). A total of 13 non-ocular AEs were reported for eight 
      LE/T-treated subjects in the two trials. The most prevalent non-ocular AEs were 
      pyrexia (three events) and rash (two events). There were no differences in the 
      incidence of specific ocular and non-ocular AEs between the LE/T group and the 
      comparator treatment group. In both studies, there were no clinically meaningful 
      reductions in vision at follow-up visits. Mean IOP and IOP changes from baseline, 
      assessed in the lid inflammation study, were not different between LE/T and 
      vehicle treatment groups at any study visits. CONCLUSION: The results of these 
      two clinical trials demonstrate the short-term safety of treatment with topical 
      LE/T in pediatric subjects (0-6 years of age) with lid inflammation or 
      blepharoconjunctivitis.
FAU - Comstock, Timothy L
AU  - Comstock TL
AD  - Global Pharmaceuticals, Bausch Lomb, Inc., Rochester, NY 14609, USA. 
      tcomstock@bausch.com
FAU - Paterno, Michael R
AU  - Paterno MR
FAU - Bateman, Kirk M
AU  - Bateman KM
FAU - Decory, Heleen H
AU  - Decory HH
FAU - Gearinger, Matthew
AU  - Gearinger M
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Switzerland
TA  - Paediatr Drugs
JT  - Paediatric drugs
JID - 100883685
RN  - 0 (Androstadienes)
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Ophthalmic Solutions)
RN  - VZ8RRZ51VK (Tobramycin)
RN  - YEH1EZ96K6 (Loteprednol Etabonate)
SB  - IM
MH  - Androstadienes/administration & dosage/*adverse effects
MH  - Anti-Allergic Agents/administration & dosage/*adverse effects
MH  - Anti-Bacterial Agents/administration & dosage/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Conjunctivitis/*chemically induced
MH  - Double-Blind Method
MH  - Drug Eruptions/etiology
MH  - Eyelids/*drug effects/*pathology
MH  - Female
MH  - Fever/chemically induced
MH  - Humans
MH  - Incidence
MH  - Infant
MH  - Infant, Newborn
MH  - Inflammation/chemically induced
MH  - Intraocular Pressure/drug effects
MH  - Loteprednol Etabonate
MH  - Male
MH  - Multicenter Studies as Topic
MH  - Ophthalmic Solutions/adverse effects
MH  - Safety
MH  - Tobramycin/administration & dosage/*adverse effects
MH  - Vision, Ocular/drug effects
MH  - Visual Acuity/drug effects
EDAT- 2012/02/02 06:00
MHDA- 2013/03/30 06:00
CRDT- 2012/02/02 06:00
PHST- 2012/02/02 06:00 [entrez]
PHST- 2012/02/02 06:00 [pubmed]
PHST- 2013/03/30 06:00 [medline]
AID - 10.2165/11596320-000000000-00000 [doi]
PST - ppublish
SO  - Paediatr Drugs. 2012 Apr 1;14(2):119-30. doi: 10.2165/11596320-000000000-00000.