Comstock 2012.

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" (participants and investigators) Study visits and time points: 4 visits: day 1 (visit 1), 3 (±1 day), 7 (±1 day), and 15 (±1 day) Treatment duration: 14 days How missing data was handled: NR Power and sample size calculation: "Approximately 145 subjects were planned to be enrolled in the blepharoconjunctivitis study to yield at least 30 evaluable subjects in each treatment group. In this study, 30 subjects within a treatment group were calculated to yield at least 90% probability of observing a specific AE, when that AE occurs at a rate of 7.2% or higher, or 95% probability of observing a specific AE, when that AE occurs at a rate of 9.5% or higher." Reporting threshold for ocular adverse events: NR *Results of two trials were reported in the report: one compared loteprednol etabonate (LE) + tobramycin vs vehicle for lid inflammation; the other one compared LE + tobramycin, LE, tobramycin, vehicle for blepharoconjunctivitis. Only relevant results of the second trial (LE + tobramycin vs vehicle, tobramycin vs vehicle) were extracted and included in the review.
Participants	Countries: USA Setting: 18 clinical sites Inclusion criteria:  Age 0‐6 years  Clinical diagnosis of blepharoconjunctivitis in at least one eye  In good health with no current or past relevant medical history as judged by the investigator  Subject's parent/guardian willing and able to comply with all treatment and follow‐up procedures  Subject's parent/guardian willing to provide informed consent Exclusion criteria:  Any uncontrolled, systemic, debilitating disease Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication  Use of concurrent ocular therapy with nonsteroidal anti‐inflammatory agent, mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study  Use of oral/topical ophthalmic corticosteroids or systemic/topical ophthalmic antibiotics (other than study medication) during the study or within 2 or 3 days, respectively, prior to the study  A history of ocular surgery, including laser procedures, within the past 6 months  Suspected vernal conjunctivitis, glaucoma of any kind, viral conjunctivitis, preseptal cellulitis that required systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication  A history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study  Participation in an ophthalmic drug or device research study within 30 days prior to entry in the study Interventions Intervention group: LE + tobramycin Age, mean ± SD (range): 3.2 ± 2.0  Female, n (%): 10 (29%) Major race/ethnicity, n (%): White, 29 (85%) Participants (eyes) randomized: 34 Participants (eyes) analyzed for efficacy outcome(s): NR Participants (eyes) analyzed for safety outcome(s): 34 Intervention group: tobramycin Age, mean ± SD (range): 2.9 ± 2.0  Female, n (%): 15 (44%) Major race/ethnicity, n (%): White, 21 (62%) Participants (eyes) randomized: 34 Participants (eyes) analyzed for efficacy outcome(s): NR Participants (eyes) analyzed for safety outcome(s): 34 Comparison group: vehicle Age, mean ± SD (range): 2.3 ± 1.8  Female, n (%): 13 (39%) Major race/ethnicity, n (%): White, 24 (73%) Participants (eyes) randomized: 34  Participants (eyes) analyzed for efficacy outcome(s): NR Participants (eyes) analyzed for safety outcome(s): 33 Overall Age, mean ± SD (range): 2.8 ± 1.95 Female, n (%): 74/102 (72.5%) Major race/ethnicity, n (%): White, 74/102 (72.5%) Participants (eyes) randomized: 102  Participants (eyes) analyzed for efficacy outcome(s): NR Participants (eyes) analyzed for safety outcome(s): 101 Baseline comparison: "Demographics were similar between treatment groups."
Interventions	LE + tobramycin 0.3% Tobramycin 0.3% Vehicle One or two drops four times per day at 4‐hour intervals for 14 days
Outcomes	Primary study outcome The incidence of AEs as to severity (mild, moderate, or severe) and causal relationship to study medication (unrelated, unlikely, possibly, probably, definitely, or not assessable/unclassified) Secondary study outcome Bilateral vision assessment (Snellen distance VA in both eyes) and  Bilateral IOP
Notes	Funding source: "The study was sponsored, designed, and conducted by Bausch & Lomb Global Clinical Programs, Rochester NY, USA." Declaration of interest: Drs. Comstock, Paterno, Bateman, and DeCory are employees of Bausch & Lomb. Dr. Gearinger is a consultant to Bausch & Lomb and developed the protocols and acted as medical monitor. Trial registry: NR Publication language: English