Clinical safety of moxifloxacin ophthalmic solution 0.5% (VIGAMOX) in pediatric and nonpediatric patients with bacterial conjunctivitis.
Five independent, multicentered, double-masked, parallel, controlled studies were conducted to determine the safety of moxifloxacin ophthalmic solution 0.5% (VIGAMOX) in pediatric and nonpediatric patients with bacterial conjunctivitis. Patients were randomized into one of two treatment groups in each study and received either moxifloxacin ophthalmic solution 0.5% b.i.d. or t.i.d. or a comparator. A total of 1,978 patients (918 pediatric and 1,060 nonpediatric) was evaluable for safety. The most frequent adverse event in the overall safety population was transient ocular discomfort, occurring at an incidence of 2.8%, which was similar to that observed with the vehicle. No treatment-related changes in ocular signs or visual acuity were observed with moxifloxacin ophthalmic solution 0.5%, except for one clinically relevant change in visual acuity. Thus, based upon a review of adverse events and an assessment of ocular parameters, moxifloxacin ophthalmic solution 0.5% formulated without the preservative, benzalkonium chloride, is safe and well tolerated in pediatric (3 days-17 years of age) and nonpediatric (18-93 years) patients with bacterial conjunctivitis.
Silver
Lewis H
LH
Alcon Research, Ltd., Fort Worth, TX 76134-2099, USA.
Woodside
Adrienne M
AM
Montgomery
Dawnelle B
DB
D000328:Adult; D001372:Aza Compounds / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy*; D024841:Fluoroquinolones; D006801:Humans; D007223:Infant; D000077266:Moxifloxacin; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects*
D001372:Aza Compounds; D024841:Fluoroquinolones; D009883:Ophthalmic Solutions; D011804:Quinolines; D000077266:Moxifloxacin