Gross 2003.

Study characteristics
Methods	Study design: parallel‐group, randomized controlled trial, two‐arm Unit of randomization: Person Masking of participants, treatment allocator, outcome assessor, or data analyzer: "double‐masked" (investigators and their staff were masked as to treatment group assignment) Study visits and time points: Initial visit (day 1), follow‐up visits (day 2, 3, and 4) and 'test‐of‐cure' visit (day 7) Treatment duration: 3 days How missing data was handled: NR Power and sample size calculation: NR Reporting threshold for ocular adverse events: NR
Participants	Country: USA Setting: multicenter Inclusion criteria:   One year of age Either sex and any race With a presumptive diagnosis of bacterial conjunctivitis based on clinical observation All patients had to have a rating of 1 (mild) or greater on a scale of 0 to 3 (absent to severe) for conjunctival discharge/exudates;  patients ≤ 5 years of age a rating of at least 1 (mild) on a scale of 0 to 3 (normal to severe) for bulbar conjunctival injection, and  patients > 5 years of age a rating of at least 2 for bulbar conjunctival injection.  Exclusion criteria: NR   Interventions Intervention group: moxifloxacin 0.5% Age, mean ± SD (range): 30 (1 to 89) Female, n (%): 24 (62%) Predominant race/ethnicity, n (%): Caucasian, 35 (90%) Participants (eyes) randomized: 39 Participants (eyes) analyzed for efficacy outcome(s): 27 Participants (eyes) analyzed for safety outcome(s): NR Comparison group: vehicle Age, mean ± SD (range): 21 (1 to 70) Female, n (%): 22 (65%) Predominant race/ethnicity, n (%): Caucasian, 28 (82%) Participants (eyes) randomized: 34 Participants (eyes) analyzed for efficacy outcome(s): 24 Participants (eyes) analyzed for safety outcome(s): NR Overall Age, mean ± SD (range): 26 (1 to 89 years) Female, n (%): 46 (63%) Predominant race/ethnicity, n (%): Caucasian, 63 (86%) Participants (eyes) randomized: 73 Participants (eyes) analyzed for efficacy outcome(s): 51 Participants (eyes) analyzed for safety outcome(s): NR Baseline comparison: NR
Interventions	Moxifloxacin ophthalmic solution 0.5% Vehicle Twice per day for 3 days
Outcomes	Treatment efficacy Clinical success: clinical cure or the disappearance of signs and symptoms of the disease during the course of the treatment. Microbiological success: the eradication of the original pathogen at the Day 7 test‐of‐cure visit, which occurred 3‐4 days after the last treatment with antibiotics. Therapeutic improvement: combines clinical success with microbiological success to obtain an overall study success outcome at Day 7 test‐of‐cure visit. Clinical utility: the clinical utility scale ranked the patients based on the day they were considered cured as well as their microbiological outcome (Table 1). Treatment failure: If the patient did not respond adequately to the assigned study therapy and needed treatment different from the assigned study regimen, the patient was classified as a "Treatment Failure" and immediately discontinued from the study. Safety An evaluation of safety was conducted on all patients who were randomized into the study and received at least one dose of the study drug. In this study, clinical cure occurred when the rating of each of the two cardinal ocular signs (bulbar conjunctival injection and conjunctival discharge/exudate) was 0 (normal or absent) at the Day 7 test‐of‐cure visit.  Clinical success included both patients whose scores went to 0 for the two cardinal signs and those patients whose scores improved. "All patients who received drug, had at least one on‐therapy visit, met inclusion criteria and were culture‐positive for bacteria on Day 1 were included in the analyses reported herein."
Notes	Funding source: NR Declaration of interest: NR Trial registry: NR Publication language: English