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V. Papa, S. Russo, D. Rasà, P. Russo, A. Di Bella, F. Faraldi, P. Vaona, G. Milazzo; Evaluation of Topical Netilmicin/Dexamethasone Combination in the Management of External Ocular Inflammation . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5001.
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Inflammation of the ocular surface – lids, conjunctiva, and cornea –can cause significant morbidity. Concomitant administration of corticosteroids and antibiotics remain a standard of care in the presence or suspect of bacterial infection. The purpose of this study was to evaluate the efficacy of a new steroid–antibiotic combination in the treatment of external ocular inflammations. Such combination (dex–net) contains 0.1% dexamethasone and 0.3% netilmicin an aminoglycoside effective against gentamicin and tobramycin resistant bacterial strains.
This was a randomized, parallel–group, equivalence study conducted in 139 patients with conjunctival hyperemia and ocular discharge. 74 patients (67%) had a lid involvement (blepharo–conjunctivitis). 41 patients (30%) had a positive conjunctival swab. 110 patients were eligible for evaluation and received either dex–net(n=55) or TOBRADEX (n=55) qid for 6 ±1 days. Hyperemia and edema of both conjunctiva and lid and ocular symptoms (tearing, burning, stinging, foreign body sensation, photophobia and pain) were graded on a scale of 3 (severe) to 0 (none). Ocular discharge was also graded as absent (0), mild (1) or severe (2). All parameters were evaluated at baseline and 6 days later. Conjunctival hyperemia was considered the primary efficacy parameter.
Dex–net was highly effective (p=0.0000, Pratt Wilcoxon test) in reducing all signs of ocular surface inflammation, in particular conjunctival hyperemia decreased from 2.32±0.54 to 0.63±0.67 (m±SD), conjunctival edema from 1.11 to 0.05; lid hyperemia from 1.07 to 0.03; lid edema from 0.89 to 0.05; discharge from 1.05 to 0.09. All symptoms decreased in a highly significant manner (p=0.0000) as well. For all parameters not statistical significant differences were observed between dex–net and TOBRADEX (90% Confidence Interval and Wilcoxon Rank Sum test). No significant increase in IOP was observed during the treatment with either dex–net(14.9±1.8 mmHg vs 15.0±1.9, m±SD) or TOBRADEX (14.4±2.0 vs 14.4±2.0). Microbiological eradication of the positive swab was achieved in 92% of patients treated with dex–net and 87% of patients treated with TOBRADEX.
Dex–net was effective and safe in reducing clinical signs of ocular inflammation (i.e., conjunctivitis, blepharitis, discharge). When compared with TOBRADEX, the two steroid–antibiotic combination provided a comparable effect. In respect to TOBRADEX the presence of netilmicin guarantees a better spectrum of activity.
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