Clinical Ophthalmology (Jun 2021)
Short-Term Use of Dexamethasone/Netilmicin Fixed Combination in Controlling Ocular Inflammation After Uncomplicated Cataract Surgery
Abstract
Aldo Caporossi,1 Giovanni Alessio,2 Francesco Fasce,3 Giorgio Marchini,4 Antonio Rapisarda,5 Vincenzo Papa6 1Department of Ophthalmology, Policlinico Universitario A. Gemelli IRCSS Università Cattolica del Sacro Cuore, Roma, Italy; 2Ophthalmology Unit, Dipartimento di Scienze mediche di base, Neuroscienze e Organi di Senso Università di Bari, Azienda Ospedaliera Policlinico Consorziale, Bari, Italy; 3Ophthalmology Unit, IRCSS San Raffaele, Milano, Italy; 4Ophthalmology Unit, Ospedale Policlinico G.B. Rossi, Università di Verona, Verona, Italy; 5Ophthalmology Unit, Azienda Ospedaliera Garibaldi, Catania, Italy; 6Medical Affairs SIFI SpA, Catania, ItalyCorrespondence: Vincenzo PapaMedical Affairs SIFI SpA, Via E. Patti 36, Aci S. Antonio, Catania, ItalyEmail [email protected]: To evaluate the short-term anti-inflammatory effect of dexamethasone/netilmicin fixed combination in the management of ocular inflammation after cataract surgery.Patients and Methods: Open-label, randomized, active-controlled, clinical study conducted in 6 sites in Italy; 238 patients were randomized 2:1 to dexamethasone/netilmicin (dexa/net, n=158) or betamethasone/chloramphenicol (beta/chl, n=80). Treatment started the day of surgery and continued 4 times daily for 7 days. The primary efficacy parameter was the anterior chamber (AC) flare. The percentage of patients displaying none or mild (ie, only barely detectable) AC flare was defined as “efficacy rate”, whereas the percentage of patients showing a decrease of AC flare score from baseline was defined as “percentage of responders”. Additional parameters evaluated were AC cells, conjunctival hyperaemia, corneal and lid oedema, symptoms of ocular discomfort, visual acuity, and intraocular pressure. Dexa/net was considered effective if the efficacy rate was not inferior (by means of 97.5% confidence interval) to that of beta/chl.Results: After 7 days of treatment, no AC flare was observed in 92.8% (dexa/net) and 92.3% (beta/chl) of patients, whereas no AC cells were observed in 91.5% (dexa/net) and 93.6% (beta/chl) of patients, respectively. The “efficacy rate” was 100% in both groups, whereas the “percentage of responders” was 94.1% in the dexa/net and 93.6% in the beta/chl group. The p-value to reject the null hypothesis of inferiority was < 0.001. Other efficacy parameters confirmed both treatments as highly effective, despite their difference in steroid content (2 mg/mL for beta/chl vs 1 mg/mL for dexa/net). IOP and visual acuity at the end of the study were comparable. Two cases of allergic conjunctivitis were considered adverse events and were both related to dexa/net.Conclusion: Short-term use of dexa/net fixed combination is safe and effective in the control of post-operative inflammation following uncomplicated cataract surgery.Keywords: cataract surgery, fixed combination, netilmicin, chloramphenicol
