A 3-day regimen with azithromycin 1.5% eyedrops for the treatment of purulent bacterial conjunctivitis in children: efficacy on clinical signs and impact on the burden of illness

Figures & data

Table 1 Patient demographics (full analysis set)

	Azithromycin (N=146)	Tobramycin (N=136)	All patients (N=282)
Sex
Male, N (%)	70 (47.9)	68 (50.0)	138 (48.9)
Female, N (%)	76 (52.1)	68 (50.0)	144 (51.1)
Age (yr)
Mean ± SD	3.06±3.40	3.52±4.17	3.28±3.79
Age category, N (%)
0 to <24 mo	76 (52.1)	72 (52.9)	148 (52.5)
24 mo to <4 yr	25 (17.1)	19 (14.0)	44 (15.6)
4 yr to <12 yr	42 (28.8)	35 (25.7)	77 (27.3)
12 yr to <18 yr	3 (2.1)	10 (7.4)	13 (4.6)

Abbreviations: mo, months; yr, years.

Figure 1 Evolution of cardinal signs of bacterial conjunctivitis.

Notes: (A) Bulbar conjunctival hyperemia; (B) purulent conjunctival discharge. Microbiologically positive full analysis set. Azithromycin group: (AZIT): N=102 on day 0, N=101 on day 3, N=96 on day 7; tobramycin group (TOBRA): N=101 on day 0, day 3, and day 7. Data presented from the worse eye.

Figure 2 Global efficacy assessment by the investigator.

Notes: (A) Day 3; (B) day 7. Microbiologically positive full analysis set. Azithromycin group: N=99 at day 3 and N=95 at day 7; tobramycin group: N=100 on day 3 and day 7. Data presented from the worse eye.

Figure 3 Number of days that an improvement was felt.

Notes: Microbiologically positive full analysis set; 65 patients in the azithromycin group and 56 patients in the tobramycin group.

Figure 4 Ease of treatment and impact on daily life.

Notes: (A) Treatment duration (P<0.001). (B) Easiness of instilling drops during the day (P<0.001). (C) Easiness of respecting the prescribed number of instillations (P<0.001). (D) Difficulty of performing usual activities (P<0.001). (Full analysis set population: 84 patients in the azithromycin group and 75 patients in the tobramycin group).

Table 2 Summary of questionnaire results among infants (aged less than 24 months)

	Azithromycin (N=76)	Tobramycin (N=72)
Global treatment efficacy “very satisfactory” or “satisfactory”	86.8% (N=46)	77.4% (N=41)
Improvement reported in the first two days of treatment	84.2% (N=38)	54.8% (N=31)
Treatment duration “very satisfactory” or “satisfactory”	92.9% (N=42)	70.0% (N=40)
Eyedrop instillation during the day “very easy” or “easy”	97.1% (N=34)	66.7% (N=42)
Respecting the prescribed number of instillations “very easy” or “easy”	100% (N=45)	54.8% (N=42)
Performing usual activities “never” difficult	75.6% (N=41)	53.7% (N=41)

Note: Full analysis set: azithromycin (N=76), tobramycin (N=72).