Abstract | BACKGROUND: OBJECTIVE: METHODS: This was a post hoc analysis of a subgroup of pediatric patients aged 1-17 years who had participated in three previously reported, randomized, double-masked, parallel-group, multicenter, clinical trials evaluating the safety and efficacy of besifloxacin in the treatment of bacterial conjunctivitis. The studies were conducted in a community setting (clinical centers). All three clinical trials included children (aged > or = 1 year) with a clinical diagnosis of bacterial conjunctivitis in at least one eye, based on the presence at baseline of grade 1 or greater purulent conjunctival discharge and conjunctival injection, and pin-hole visual acuity of at least 20/200 in both eyes for verbal patients. Two trials were vehicle controlled; the third trial was comparator controlled ( moxifloxacin hydrochloride ophthalmic solution 0.5% as base). In all studies, besifloxacin ophthalmic suspension 0.6% was administered as one drop in the affected eye(s) three times daily, at approximately 6-hourly intervals, for 5 days. The main outcome measures were clinical resolution and microbial eradication at visit 2 (day 4 +/- 1 in one study; day 5 +/- 1 in the other two studies) and visit 3 (day 8 or 9). Data from the two vehicle-controlled studies were combined for the assessments to provide greater statistical power. RESULTS: This analysis included 815 pediatric patients aged 1-17 years (447 with culture-confirmed bacterial conjunctivitis). Clinical resolution was significantly greater (p < 0.05) in the besifloxacin group than in the vehicle group at both visit 2 (53.7% vs 41.3%) and visit 3 (88.1% vs 73.0%). Similarly, microbial eradication was significantly higher with besifloxacin than with vehicle at visit 2 (85.8% vs 56.3%) and visit 3 (82.8% vs 68.3%). No significant differences in clinical resolution and microbial eradication were noted between besifloxacin and moxifloxacin. Besifloxacin was well tolerated, with similar incidences of adverse events in the besifloxacin, vehicle, and moxifloxacin groups. CONCLUSION:
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Authors | Timothy L Comstock, Michael R Paterno, Dale W Usner, Michael E Pichichero |
Journal | Paediatric drugs
(Paediatr Drugs)
Vol. 12
Issue 2
Pg. 105-12
(Apr 01 2010)
ISSN: 1179-2019 [Electronic] Switzerland |
PMID | 20218747
(Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Aza Compounds
- Azepines
- Fluoroquinolones
- Ophthalmic Solutions
- Quinolines
- besifloxacin
- Moxifloxacin
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Topics |
- Administration, Topical
- Adolescent
- Anti-Bacterial Agents
(administration & dosage, adverse effects, therapeutic use)
- Aza Compounds
(adverse effects, therapeutic use)
- Azepines
(administration & dosage, adverse effects, therapeutic use)
- Child
- Child, Preschool
- Conjunctivitis, Bacterial
(drug therapy, microbiology)
- Double-Blind Method
- Female
- Fluoroquinolones
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Infant
- Male
- Moxifloxacin
- Ophthalmic Solutions
- Quinolines
(adverse effects, therapeutic use)
- Randomized Controlled Trials as Topic
- Treatment Outcome
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