Effectiveness, tolerability and safety of azithromycin 1% in DuraSite^® for acute bacterial conjunctivitis

Figures & data

Table 1 Randomized controlled trials assessing the clinical effectiveness of azithromycin 1% in DuraSite^®

Author, references	Number of patients/patient age	Azithromycin	Comparator	Result	Quality
Abelson^Citation26	N = 279 Age 1–96	1% in DuraSite^® dosed twice daily on days 1–2 and once daily on days 3–5	Vehicle with same dosing schedule; vehicle was identically supplied and formulated except that it contained no azithromycin.	Clinical resolution with azithromycin in DuraSite^® was statistically improved compared with that of vehicle P = 0.03	Prospective randomized vehicle-controlled, double-masked study. Randomization protocol not explained in study. Allocation concealment appears to be adequate during enrolment. Possible problem as “data monitoring committee” was not blinded, although these team members did not have any contact with study participants.
Abelson^Citation27 Unpublished	N = 685 Age not available	1% in DuraSite^® dosed twice daily for days 1–2 and four times a day for days 3–5	Vehicle with same dosing schedule.	Clinical resolution and bacterial eradication significantly better in the azithromycin group than in the vehicle group P < 0.05.	Unpublished study, double–masked and randomized, but insufficient information to determine quality.
Abelson^Citation29	N = 316 Age 1–83	1% in DuraSite^® dosed twice a day with active drug on days 1–2 and once daily days 3–5, other doses were vehicle.	Tobramycin 0.3% four times a day	Clinical resolution was 79.9% in azithromycin group and 78.3% in the tobramycin group. The difference in clinical resolution between the two groups was not statistically significant (P = 0.78).	Although the study states that it was randomized there is no explanation of sequence generation or allocation concealment during enrolment. Patients could not have been blinded to their treatment as the viscosity of the drops would be different. The results may also be affected by incomplete outcome data (ie, 17 patient withdrawals due to adverse events, 16 patients lost to follow-up, withdrawn consent or lack of efficacy).

Table 2 Randomized controlled trials assessing safety and tolerability of azithromycin 1% in DuraSite^®

Author, references	Number of patients/patient age	Azithromycin	Comparator	Result	Quality
Heller^Citation27	N = 685 Age 1–96	1% in DuraSite^® twice daily for 2 days then four times a day for days 3–5 in adults and children.	Vehicle with same dosing schedule.	12% of patients experienced at least one adverse event in both the Azasite (azithromycin 1% in DuraSite^®) and vehicle groups. No drug-related serious adverse events.	Unpublished study from Cochrane register of trials. Double-masked and randomized. No summary statistics reported.
Protzko^Citation28	N = 743 Age 1–93	1% in DuraSite^® dosed twice a day with active drug on days 1 and 2 and once daily days 3–5; other doses were vehicle.	0.3% Tobramycin four times a day for 5 days.	Both medications well-tolerated. A reported 3% of azithromycin group and 5.6% of tobramycin group had treatment-related adverse events. Rates of microbial eradication and bacterial infection recurrence were the same in both groups.	Prospective randomized active-controlled double masked study, but no details of randomization protocol given in study. The medication was masked. No odds ratios reported.
Granet^Citation28	N = 125 34 adults and 50 children received moxifloxacin and contralateral azithromycin; 11 adults and 10 children received moxifloxacin and contralateral placebo	1% azithromycin in DuraSite^®	Tears Natural II^® or moxifloxacin 0.5% in contralateral eyes.	Ocular adverse events were observed in 17% of participants receiving azithromycin 1% in DuraSite^® and 1% receiving moxifloxacin. Moxifloxacin was significantly more tolerable in healthy eyes.	This study was supported by Alcon and used Alcon’s preparation of moxifloxacin. No summary statistics were reported.

HellerWAbelsonMGroupTASSafety and tolerabiltiy of azithromycin 1% eye drops as anti-infective therapy for bacteria conjunctivitisUnpublished study for the Cochrane Register of Controlled Trials (CENTRAL)Study ID CN 00634521.

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