Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation

Figures & data

Table 1 Demographic data (randomized patients)

	Netildex (n = 71)	Tobradex (n = 68)	All Patients (n = 139)
Sex
Female	33	34	67
Male	38	34	72
Age (years)
Mean	52.4	49.4	50.9
SD	15.4	17.6	16.5
Range	20–81	18–82	18–82
Race
Caucasian	69	68	137
Other	2	0	2

Abbreviation: SD, standard deviation.

Figure 1 Effect of steroid/antibiotic combinations on conjunctival score.

Notes: Conjunctival hyperemia was evaluated by using a categorical semiquantitative grading scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe) at baseline, after 6 days of treatment with netildex or Tobradex, and after 8 more days (follow-up visit at Day 14). Data are expressed as mean score ± SD. *Pratt–Wilcoxon test: P < 0.0001 (vs baseline).
Abbreviation: SD, standard deviation.

Table 2 Effect on conjunctival hyperemia

Grading scale (% variation)	Netildex	Tobradex	P-value*
	Mean ± SD	Mean ± SD
FA population	−71.8 ± 31.1	70.0 ± 27.7	0.566
PP population	−71.6 ± 31.5	70.4 ± 27.8	0.632
Responder rate	% (n/N)	% (n/N)	P-value†	Difference 95% CI
FA dataset	87.3 (48/55)	90.9 (50/55)	0.541	−3.6 (−15.3 ÷ 8.0)
PP dataset	86.3 (44/51)	90.7 (49/54)	0.472	−4.5 (−16.7 ÷ 7.7)

Notes: Conjunctival hyperemia was evaluated by using a categorical semiquantitative grading scale as described in Materials and methods. Grading scale (% variation) indicates the percentage of variation for conjunctival hyperemia grading scale at Day 6 from baseline. Responder rate indicates the percentage of patients with an improvement ≥50% of conjunctival hyperemia grading scale at Day 6 over baseline.

* Analysis of variance;

† Chi-square test.

Abbreviations: CI, confidence interval; FA, full analysis; n/N, number over total; PP, per protocol; SD, standard deviation.

Table 3 Effect of the presence of ocular infection on the responder rate (FA dataset)

	Netildex	Tobradex	P value*	Difference 95% CI
	Responder rate (n/N)	Responder rate (n/N)
Culture-positive	81.2 (13/16)	82.3 (14/17)	0.935	1.1 (25.2 ÷ 27.4)
Culture-negative	89.7 (35/39)	94.7 (36/38)	0.395	5.3 (−6.8 ÷ 17.3)

Notes: Conjunctival hyperemia was evaluated by using a categorical semiquantitative grading scale as described in Materials and methods. The responder rate indicates the percentage of patients with an improvement ≥50% of conjunctival hyperemia grading scale over baseline. The presence of ocular infection was assessed by performing a conjunctival swab at Day 1. The identification of microorganisms grown in culture was performed using the API system. An ocular specimen was considered culture positive if the CFU count reached the threshold values described by Cagle.¹³

* Chi-square test.

Abbreviations: API, analytical profile index; CFU, colony forming unit; CI, confidence interval; FA, full-analysis dataset; n/N, number over total.

Table 4 Effect on clinical secondary parameters (FA dataset)

Clinical parameters	(Score difference)		P-value*
	Netildex	Tobradex
Conjunctival edema	1.04 ± 0.96	0.76 ± 0.82	0.134
Conjunctival discharge	0.96 ± 0.58	0.98 ± 0.30	0.975
Lid hyperemia	1.02 ± 0.89	0.62 ± 0.62	0.016
Lid edema	0.84 ± 0.94	0.53 ± 0.69	0.093
Pain	0.85 ± 0.93	0.65 ± 0.75	0.332
Photophobia	1.36 ± 0.91	1.16 ± 0.79	0.339
Tearing	1.71 ± 0.90	1.18 ± 0.77	0.001
Burning	1.51 ± 0.81	1.13 ± 0.77	0.007
Stinging	1.27 ± 0.76	0.85 ± 0.80	0.004
Foreign body sensation	1.29 ± 0.92	1.16 ± 0.60	0.464

Notes: All clinical parameters were evaluated by using a categorical semiquantitative grading scale as described in Materials and methods. The score difference for each parameter at Day 6 from baseline was evaluated.

* Wilcoxon rank-sum test. Values in bold are statistically significant.

Abbreviation: FA, full-analysis dataset.

PianiniVPassaniARossiGCMPassaniFEfficacy and safety of netilmicin/dexamethasone preservative-free and tobramycin/dexamethasone-preserved fixed combination in patients after cataract surgeryJ Ocul Pharmacol Ther201026661762121034176

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