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Vincenzo Papa, Daria Rasà, Claudio Iannacone, Cristina Cannatella, Antonio Rapisarda, Netildex Gel Study Group; Clinical Efficacy and Safety of Dexamethasone/Netilmicin Gel in the Management of Ocular Inflammation After Vitreoretinal Surgery. Invest. Ophthalmol. Vis. Sci. 2013;54(15):5783.
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To evaluate the efficacy and safety of a new hydrogel formulation of Netildex (SIFI SpA, Italy), a preservative-free steroid/antibiotic fixed combination containing 0.1% dexamethasone and 0.3% netilmicin plus 1% xanthan gum (as vehicle), in the treatment of ocular inflammation after microincisional vitreoretinal surgery.
The study was a multicentre, randomized, open, active-controlled clinical trial. After sutureless 23-25 gauge vitreoretinal surgery, patients received Netildex eye gel (n=50) or Tobradex eye-ointment (n= 53) qid for 3 days; treatment continued until day 14 after surgery with a combination of eye-drops tid, during daytime, and eye gel or ointment sid at bed time. Efficacy parameters evaluated were: conjunctival hyperemia, anterior chamber flare and cells, symptoms of ocular discomfort (pain, photophobia, itching) and presence of ocular infection. All parameters were graded on a scale of 0 (none) to 3 (severe) with the exception of symptoms that were evaluated by a VARS scale. The primary outcome was the percentage of patients showing a resolution of bulbar conjunctival hyperaemia at postoperative day 14. Safety variables examined were: symptoms of local tolerance, adverse events and IOP.
In the full analysis 92.9% and 75.0% of patients in the Netildex and Tobradex groups, respectively, had a complete resolution of bulbar conjunctiva hyperemia at day 14 (p=0.02, Fisher's exact test). No differences were found for all other efficacy parameters evaluated. Neither ocular infections nor increase in IOP were observed during the study. Statistically significant differences in favor of Netildex (p< 0.0001, ANOVA) were found for most of subjective tolerance variables examined (blurred vision, foreign body sensation, stickiness and burning).
Netildex is safe and effective in the treatment of postoperative ocular inflammation. The new Netildex hydrogel formulation is characterized by a better tolerability profile than Tobradex eye ointments. In addition it does not contain preservative thus providing an additional benefit to patients.
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