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. 2023 Mar 13;2023(3):CD001211. doi: 10.1002/14651858.CD001211.pub4

Malhotra 2013.

Study characteristics
Methods Study design: parallel‐group, randomized controlled trial, two‐arm
Unit of randomization: Person (only one eye from each subject was designated as the study eye)
Masking of participants, treatment allocator, outcome assessor, or data analyzer: "double‐masked." "The investigators, subjects, and all other study personnel involved in the monitoring or conduct of the study were masked to the treatment received."
Study visits and time points: Beginning at the first visit (Visit 1, Day 1), subjects instilled one drop of study treatment, outcome was assessed on day 8 (or +1 day, visit 2); day 11 (± 1 day, visit 3)
Treatment duration: 7 days
How missing data was handled: "missing or discontinued subjects were not imputed".
Power and sample size calculation: "Sample size calculations determined that at least 324 subjects were needed in the besifloxacin group to provide a 95% probability of detecting TEAEs that occur at a rate of 1%, and 162 subjects were needed in the vehicle group to provide an 80% probability of detecting TEAEs that occur at a rate of 1%. Assuming a 10% dropout rate, it was planned to enroll 540 subjects to yield the minimum required total of 486 patients."
Reporting threshold for ocular adverse events: NR
Participants Countries: USA
Setting: 24 sites
Inclusion criteria: 

  1. Age 1 year or greater; 

  2. Clinical diagnosis of bacterial conjunctivitis as evidenced by a minimum grade of 1 for both purulent conjunctival discharge (scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe) and bulbar conjunctival injection (Scale: 0 = normal; 1 = mild; 2 = moderate; 3 = severe) in at least one eye; and 

  3. Pin‐hole visual acuity (VA) equal to or better than 20/200 in both eyes (using age‐ appropriate VA testing). 


All subjects using contact lenses were instructed to discontinue contact lens wear for the entire study.
Exclusion criteria: 

  1. Uncontrolled systemic and/or debilitating disease; 

  2. Known hypersensitivity to besifloxacin, fluoroquinolones, or any component of the study medication; 

  3. Current or expected treatment with systemic NSAIDs (exception: B81 mg/day of acetylsalicylic acid), systemic corticosteroids, systemic antihistamines, systemic antibacterial agents; 

  4. Current or anticipated ocular therapy (either eye) with any ophthalmic solutions (tear substitutes, corticosteroids, NSAIDs, mast cell stabilizers, antihistamines, decongestants, antibacterial agents, immunosuppressant agents); 

  5. Ocular surgery (including laser surgery), either eye, within 6 weeks prior to study entry; 

  6. Suspected viral or allergic conjunctivitis; suspected iritis; 

  7. History of recurrent corneal erosion syndrome; active ulcerative keratitis; and compromised immunity.


Interventions

  • Intervention group: besifloxacin 0.6%


Age, mean ± SD (range): 29.6 ± 25.1  (1 to 97)
Female, n (%): 204/344 (59.3%)
Major race/ethnicity, n (%): White, 210/344 (61.0%)
Participants (eyes) randomized: 347
Participants (eyes) analyzed for efficacy outcome(s): 212
Participants (eyes) analyzed for safety outcome(s): 344

  • Comparison group: vehicle


Age, mean ± SD (range): 30.5 ± 22.5 (1 to 92)
Female, n (%): 95/170 (55.9%)
Major race/ethnicity, n (%): White, 102/170 (60.0%)
Participants (eyes) randomized: 170
Participants (eyes) analyzed for efficacy outcome(s): 87
Participants (eyes) analyzed for safety outcome(s): 170

  • Overall


Age, mean ± SD (range): 29.9 ± 24.25 (1 to 97)
Female, n (%): 299/514 (58.2%)
Major race/ethnicity, n (%): White, 312/514 (60.7%)
Participants (eyes) randomized: 514
Participants (eyes) analyzed for efficacy outcome(s): 299
Participants (eyes) analyzed for safety outcome(s): 514
Baseline comparison: "In both populations (ITT and mITT), baseline demographics were similar between treatment groups (Table 1), as was ocular medical history."
Interventions

  • Besifloxacin ophthalmic suspension 0.6 %

  • Vehicle


One drop in the infected eye(s) three times daily at approximately 6‐h intervals, continuing through Day 7.
Outcomes Primary study outcome

  1. The primary safety variable was the incidence of ocular and non‐ocular treatment‐emergent adverse events (TEAEs). For each TEAE, the investigator assessed the severity and causality with respect to treatment. Ocular TEAEs observed in baseline‐designated study eyes were of primary interest and are reported here.


Secondary study outcome

  1. Bacterial eradication assessed at Visits 2 and 3, which was defined as the absence of all ocular bacterial species present at or above threshold at baseline.
Notes Funding source: This study was sponsored by Bausch & Lomb Incorporated (Rochester, NY, USA). Clinical monitoring and clinical trial supplies were provided by Bausch & Lomb.
Declaration of interest: NR
Trial registry:  NCT01175590 (clinicaltrials.gov)
Publication language: English