Abstract
Purpose: :
Transmission of infection from an affected eye to the non-affected fellow eye occurs in bacterial conjunctivitis. The extent to which concurrent treatment of non-affected fellow eye would prevent spread of infection was assessed.
Methods: :
A new formulation of moxifloxacin 0.5% (MoxezaTM) was recently approved by the FDA for treating bacterial conjunctivitis. The dosing posology was BID for 3 days in this multi-center, vehicle-controlled, randomized, double-masked, parallel group study. For purposes of this analysis, affected eye was defined as one that met inclusion/exclusion criteria, had a score of ≥1 for bulbar conjunctival injection and discharge/lid crusting, and was positive for the presence of bacterial pathogen(s) prior to the initiation of therapy. A non-affected fellow eye was one that presented with normal bulbar conjunctival injection (score of 0) and no conjunctival discharge/lid crusting (score of 0). The determination of transmission to the fellow eye was based on the cardinal signs of bacterial conjunctivitis at the post-therapy visit.
Results: :
Of the 1180 patients enrolled in the study, 385 patients met the criteria for inclusion in this analysis. In the moxifloxacin-treated arm, 5% of patients (10 of 196) developed signs of conjunctivitis in the fellow eye by the end of therapy. In the vehicle-treated arm, 15% of patients (29 of 189) developed signs of infection. The improved prevention of infection spread is mirrored by the greater eradication of the principal pathogens by moxifloxacin compared to its vehicle in all culture-positive patients (N = 847): Staphylococcus aureus 95.8% vs 77.8%, Streptococcus pneumoniae 82.8% vs 50.0%, and Haemophilus influenzae 95.9 vs 56.5%.
Conclusions: :
The treatment regimen (BID for three days) for bacterial conjunctivitis with the new formulation of moxifloxacin reduced the transmission of infection from the affected eye to the non-affected eye. Other pathogen reservoirs, i.e., the nares and upper respiratory system, may have contributed to the infections that occurred in the fellow eye during and after therapy.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00759148
Keywords: antibiotics/antifungals/antiparasitics • bacterial disease • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials