Abelson 2008.

Study characteristics
Methods	Study design: parallel‐group, randomized controlled trial, two‐arm Unit of randomization: Person (block randomization) Masking of participants, treatment allocator, outcome assessor, or data analyzer: "double‐masked" Study visits and time points: visit 1 (day 1, study entry), visit 2 (day 3 or 4), and visit 3 (day 6 or 7) Treatment duration: 5 days How missing data was handled: "If data were missing for visit 3 (last efficacy visit), a last observation carried forward method was used." Power and sample size calculation: "The planned target enrollment was set at 560 participants (to enroll at least 224 participants with bacterially confirmed conjunctivitis, with 112 per treatment group) calculated based on a power of 0.90 and  0.05." Reporting threshold for ocular adverse events: 1%
Participants	Countries: U.S.A., Mexico, Guatemala, and the Dominican Republic Setting: 58 clinical centers Inclusion criteria:  1. Male or female 2. Age one year or older 3. Had a positive clinical diagnosis of acute bacterial conjunctivitis with signs and symptoms present for fewer than 3 days. A minimum score of 1 (on a scale from 0 (absent/normal) to 3 (severe)) for ocular discharge and either bulbar or palpebral conjunctival injection in the same eye 4. A best–corrected visual acuity (BCVA) score of 20/100 or better in each eye was also required.  Exclusion criteria: Any uncontrolled, systemic, debilitating disease Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study. Use of any topical ophthalmic anti‐inflammatory agents within 48 hours before and during the study. Any active upper respiratory tract infection. Pregnant or nursing females. Use of any antibiotic (topical or systemic) within 72 hours of enrollment Interventions Intervention group: azithromycin 1% Age, mean ± SD (range): 31.0 ± 23.2 (1 to 84) Female, n (%): NR Predominant race/ethnicity, n (%): NR Participants (eyes) randomized: 335 Participants (eyes) analyzed for efficacy outcome(s): 130 Participants (eyes) analyzed for safety outcome(s): 333 Comparison group: vehicle Age, mean ± SD (range): 31.0 ± 23.9 (1 to 96) Female, n (%): NR Predominant race/ethnicity, n (%): NR Participants (eyes) randomized: 350 Participants (eyes) analyzed for efficacy outcome(s): 149 Participants (eyes) analyzed for safety outcome(s): 350 Overall Age, mean ± SD (range): 31.0 ± 23.5 (1 to 96) Female, n (%): NR Predominant race/ethicity, n (%): NR Participants (eyes) randomized: 685 Participants (eyes) analyzed for efficacy outcome(s): 279 Participants (eyes) analyzed for safety outcome(s): 683 Baseline comparison: "There were no significant differences between the treatment groups in age, gender, race, or eye color."
Interventions	Azithromycin 1% in DuraSite Vehicle A single (topical) drop twice daily on days 1 and 2 and once daily on days 3 through 5
Outcomes	Primary study outcome Clinical resolution, was evaluated at the test‐of‐cure visit (visit 3 on day 6 or 7) in the per‐protocol population, defined as all randomized subjects who received at least one drop of the study medication and who had baseline culture results indicating pathogenic bacteria levels.  Clinical resolution was defined as the absence of the three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection). Secondary study outcome Bacterial eradication at visit 3 (on day 6 or 7), as indicated by the absence of bacterial growth. Bacterial outcome was scored categorically from 0 (eradicated) to 3 (worsening) compared with baseline. Safety was assessed by the incidence of adverse events (AEs) and changes in BCVA, biomicroscopy, and ophthalmoscopy. All AEs and ocular AEs occurring in more than 5% in either treatment group were summarized. Ocular AEs were classified as ocular burning or stinging or foreign body sensation on instillation, other subject‐reported ocular changes, clinically significant worsening of BCVA, and treatment‐emergent changes observed with biomicroscopy and ophthalmoscopy.
Notes	Funding source: Insite Vision, Alameda CA Declaration of interest: The authors indicate no financial conflict of interest. Yet, "Drs Abelson and Shapiro are employees of Ophthalmic Research Associates (ORA). Drs Si, Hsu, and Bowman are employees of InSite Vision. Drs Bowman and Si have patents related to this article." Trial registry: NCT00105534 (clinicaltrials.gov) Publication language: English