Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study

Acute infective conjunctivitis in primary care: who needs antibiotics? An individual patient data meta-analysis

“…Three more-recent studies, not carried out in primary care, have shown a significant effect of antibiotics for conjunctivitis. [20][21][22] It is difficult to compare the present studies with these three recent trials in secondary care, as their focus was microbiological rather than clinical. All three trials confined their analyses to culture-positive patients, and hence excluded over half the randomised patients.…”

Clinical outcomes with besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis due to potentially consequential pathogens

“…Previous multicenter, randomized, double-masked, controlled clinical studies have established the safety and efficacy of besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial conjunctivitis, whether administered thrice daily for 5 days [53][54][55] or twice daily for 3 days. 56 In each of these studies, clinical efficacy was demonstrated for patients with culture-confirmed bacterial conjunctivitis when pooling infections by all causative pathogens (Table 1) and also in the following subsets: infections due to Gram-positive pathogens; infections due to Gram-negative infections; and infections due to H. influenzae, S. pneumoniae, S. aureus, or S. epidermidis, the most prevalent bacterial pathogens in these studies.…”

“…Individual study results have been published previously. [53][54][55][56] The active comparator study 55 and two of the vehicle-controlled studies 53,54 employed a 5-day thrice-daily treatment regimen, while the third vehicle-controlled study 56 employed a 3-day twice-daily treatment regimen (Table 1).…”

“…[53][54][55][56] Briefly, eligible patients were aged $1 year with a diagnosis of bacterial conjunctivitis, as evidenced by a severity for both purulent ocular discharge and bulbar conjunctival injection of grade 1 or higher on a 4-point scale (0= absent, 1= mild, 2= moderate, and 3= severe) in at least one eye, and had a pinhole visual acuity (VA) of 20/200 or better in both eyes. The severity of bulbar conjunctival injection was determined using photographic standards (Ora Calibra TM Bacterial Conjunctivitis Bulbar Conjunctiva Redness Scale; Ora Inc., North Andover, MA, USA) employed in previous conjunctivitis research.…”

“…Samples for microbial cultures were taken from the conjunctival cul-de-sac of the affected eye(s), and patients were randomized to study treatment. Patients were instructed to administer one drop of study medication in the affected eye(s) three times daily at approximately 6-hour intervals for 5 days, [53][54][55] or twice daily at approximately 8-hour intervals during waking hours for a total of 3 days. 56 Patients returned to the study site at or near the end of treatment (visit 2, day 5 [±1] 53,55 or day 4 or 5 54,56 ) and after treatment ended on days 7 through 9 (visit 3, day 8 or 9 [53][54][55] ) for clinical assessment of ocular signs and symptoms, VA testing, biomicroscopy, ophthalmoscopy (visit 3 only), and culture of infected eye(s).…”