Abstract | BACKGROUND AND OBJECTIVE: STUDY DESIGN: This was a multicenter, double-masked, randomized, vehicle-controlled, parallel-group study. METHODS: A total of 474 patients aged ≥1 year with bacterial conjunctivitis were randomized in a 1 : 1 ratio to receive either besifloxacin ophthalmic suspension 0.6% or vehicle administered twice daily for 3 days. There were three study visits: day 1 (the baseline visit), day 4/5 (visit 2), and day 7 ± 1 (visit 3). The co-primary efficacy endpoints were bacterial eradication and clinical resolution at day 4/5 in designated study eyes of patients with culture-confirmed bacterial conjunctivitis. Secondary efficacy endpoints were bacterial eradication and clinical resolution at day 7 ± 1, individual clinical outcomes of ocular discharge and bulbar conjunctival injection at all visits; and microbial and clinical outcomes for overall bacterial species and individual Gram-positive and Gram-negative bacterial species at each follow-up visit. Safety endpoints included adverse events (AEs), changes in visual acuity and biomicroscopy findings at each visit, and changes in ophthalmoscopy findings at day 7 ± 1. RESULTS: Bacterial eradication and clinical resolution rates were significantly higher in the besifloxacin group than in the vehicle group (115/135 [85.2%] vs 77/141 [54.6%], p < 0.001, and 89/135 [65.9%] vs 62/141 [44.0%], p < 0.001, respectively) at day 4/5. Rates of bacterial eradication continued to be significantly greater in the besifloxacin group (115/135 [85.2%] vs 91/141 [64.5%], respectively; p < 0.001) at day 7 ± 1; however, the rates of clinical resolution did not differ significantly between the groups (103/135 [76.3%] and 94/141 [66.7%], p = 0.209) at this visit. Ocular discharge and bulbar conjunctival injection at each visit were consistent with the primary outcomes. Clinical resolution and bacterial eradication with Gram-positive or Gram-negative organisms were consistent with the overall findings. All AEs in both groups were of mild or moderate severity and were considered unrelated to the treatment. CONCLUSION: CLINICAL TRIAL REGISTRATION: Registered at ClinicalTrials.gov as NCT00972777.
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Authors | Jesse DeLeon, Bruce E Silverstein, Catherine Allaire, Lynne S Gearinger, Kirk M Bateman, Timothy W Morris, Timothy L Comstock |
Journal | Clinical drug investigation
(Clin Drug Investig)
Vol. 32
Issue 5
Pg. 303-17
(May 01 2012)
ISSN: 1179-1918 [Electronic] New Zealand |
PMID | 22420526
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Azepines
- Fluoroquinolones
- Suspensions
- besifloxacin
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Topics |
- Administration, Ophthalmic
- Adolescent
- Adult
- Anti-Bacterial Agents
(administration & dosage, 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)
- Follow-Up Studies
- Gram-Negative Bacteria
(isolation & purification)
- Gram-Positive Bacteria
(isolation & purification)
- Humans
- Infant
- Male
- Middle Aged
- Ophthalmoscopy
- Suspensions
- Treatment Outcome
- Young Adult
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