Table 2.
Randomized controlled trials on azithromycin ophthalmic solution, for the treatment of bacterial conjunctivitis*
| Author | Quality | Number of patients (age range) | Indication | Dosage of azithromycin eye drop | Result |
|---|---|---|---|---|---|
| Abelson15 | Clinical efficacy | 159 patients received 1% azithromycin, 157 patients received 0.3% tobramycin (1 to 83 years old) | Clinically diagnosed bacterial conjunctivitis | bid on days 1 and 2, qd on days 3 to 5 | Clinical resolution 79.9% with AzaSite®, 78.3% with tobramycin; bacterial eradication 88.1% with AzaSite®, 94.3% with tobramycin at day 6 or 7 |
| Abelson3 | Clinical efficacy | 130 patients received 1% azithromycin, 149 patients received vehicle (1 to 96 years old) | Clinically diagnosed bacterial conjunctivitis | bid on days 1 and 2, qd on days 3 to 5 | Clinical resolution 63.1% with AzaSite®, 49.7% with vehicle; bacterial eradication 88.5% with AzaSite®, 66.4% with vehicle at day 6 or 7 |
| Abelson, Unpublished38 | Clinical efficacy | 685 patients (age not available) | Clinically diagnosed bacterial conjunctivitis | bid on days 1 and 2, qd on days 3 to 5 | Clinical resolution and bacterial eradication were significantly better in patients who received 1% azithromycin compared to patients who received vehicle |
| Heller, Unpublished39 | Safety and tolerability | 685 patients (1 to 96 years old) | Clinically diagnosed bacterial conjunctivitis | bid on days 1 and 2, qd on days 3 to 5 | 12% of patients had at least one adverse event in both groups of patients who received 1% azithromycin and who received vehicle |
| Protzko40 | Safety and tolerability | 343 patients received 1% azithromycin, 367 patients received 0.3% tobramycin (1 to 96 years old) | Clinically diagnosed bacterial conjunctivitis | bid on days 1 and 2, qd on days 3 to 5 | The most common adverse events were eye irritation, conjunctival hyperemia and worsening of bacterial conjunctivitis were observed in 1.1 to 1.9% of patients who received azithromycin and 1.1 to 2.1% of patients who received tobramycin. The rates of microbial eradication and bacterial infection recurrence were same in both groups. |
| Granet33 | Safety and tolerability | 84 subjects received 0.5% moxifloxacin and contralateral 1% azithromycin, 21 subjects received 0.5% moxifloxacin and contralateral placebo, 20 subjects received 1% azithromycin and contralateral placebo (≥9 years old) | Healthy subjects | One drop only | Moxifloxacin was rated more comfortable and acceptable with less blurring than azithromycin. Redness, irritation, stinging, burning, dryness, itching and chemosis were observed in 17.3% of eyes receiving azithromycin and 1% of eyes receiving moxifloxacin |
| Cochereau41 | Clinical efficacy and safety | 524 patients received 1.5% azithromycin, 519 patients received 0.3% tobramycin (4 days old to 87 years old) | Clinically diagnosed bacterial conjunctivitis | bid for 3 days | Clinical resolution 87.8% with azithromycin, 89.4% with tobramycin on day 9; bacterial eradication 85.2% with azithromycin, 83.8% with tobramycin at day 3, and 92.8% vs 94.6% at day 9, respectively. Treatment related minor adverse events (ie, burning, foreign body sensation, discharge) were noted in 3 patients in azithromycin group and 1 patient in tobramycin group |
| Bremond-Gignac42 | Clinical efficacy and safety | 73 patients received 1% azithromycin, 77 patients received 0.3% tobramycin (4 to 17 years old) | Clinically diagnosed bacterial conjunctivitis | bid for 3 days | Clinical resolution 80% with AzaSite®, 81.8% with tobramycin on day 9; bacterial eradication 94.1% with AzaSite®, 76.2% with tobramycin at day 3. Itching, burning, stinging were noted in 1 patient in azithromycin group and 2 patients in tobramycin group. |
Notes:
*
Table modified from McLean S, Sheikh A. Effectiveness, tolerability and safety of azithromycin 1% in DuraSite® for acute bacterial conjunctivitis. Patient Prefer Adherence. 2010;4:69–76.