May 2006
Volume 47, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2006
Evaluation of Topical Netilmicin/Dexamethasone Combination in the Management of External Ocular Inflammation
Author Affiliations & Notes
  • V. Papa
    Medical Dept, SIFI SPA, Lavinaio, Italy
  • S. Russo
    Medical Dept, SIFI SPA, Lavinaio, Italy
  • D. Rasà
    Medical Dept, SIFI SPA, Lavinaio, Italy
  • P. Russo
    Medical Dept, SIFI SPA, Lavinaio, Italy
  • A. Di Bella
    Medical Dept, SIFI SPA, Lavinaio, Italy
  • F. Faraldi
    Glaucoma Unit, Ophthalmic Hospital, Turin, Italy
  • P. Vaona
    Glaucoma Unit, Ophthalmic Hospital, Turin, Italy
  • G. Milazzo
    Medical Dept, SIFI SPA, Lavinaio, Italy
  • Footnotes
    Commercial Relationships  V. Papa, SIFI SpA, E; S. Russo, SIFI SpA, E; D. Rasà, SIFI SpA, E; P. Russo, SIFI SpA, E; A. Di Bella, SIFI SpA, E; F. Faraldi, None; P. Vaona, None; G. Milazzo, SIFI SpA, E.
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science May 2006, Vol.47, 5001. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : 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.

Methods: : 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.

Results: : 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.

Conclusions: : 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.

Keywords: conjunctivitis • inflammation • pharmacology 
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