PMID- 16167290 OWN - NLM STAT- MEDLINE DCOM- 20051104 LR - 20171206 IS - 1120-6721 (Print) IS - 1120-6721 (Linking) VI - 15 IP - 5 DP - 2005 Sep-Oct TI - Topical nonsteroidal anti-inflammatory drugs in uncomplicated cataract surgery: effect of sodium naproxen. PG - 598-606 AB - PURPOSE: To investigate whether topical nonsteroidal antiinflammatory drugs (NSAIDs) are useful, in the absence of concomitant corticosteroid therapy, in limiting postoperative inflammation after uncomplicated cataract surgery. METHODS: A total of 328 patients were enrolled in a prospective, randomized, double-masked, parallel-group, active-controlled study. Anterior chamber inflammation (ACI) was evaluated as the primary efficacy parameter. Only patients with moderate inflammation (ACI score of < or =4) the day after surgery were randomized and treated with NSAIDs. A novel topical formulation containing 0.2% sodium naproxen was compared with 0.1% diclofenac. Both were administered three times a day for 14 consecutive days. Ocular inflammation was measured after 7 and 14 days by using slit-lamp biomicroscopy. Safety parameters were also evaluated at the same time. RESULTS: Both treatments were equally effective in controlling postsurgical inflammation. No statistically significant differences between treatment groups were observed for the safety variables. No serious adverse events (AEs) occurred during the course of the study. The most frequent AE reported with naproxen was eye redness. CONCLUSIONS: NSAIDs can effectively be used without concurrent administration of corticosteroids to control postoperative inflammation after uncomplicated cataract surgery. In addition, naproxen ophthalmic solution may be considered a suitable alternative to the currently available NSAIDs. FAU - Russo, P AU - Russo P AD - Medical Department SIFI SpA, Catania, Italy. piero_russo@sifi.it FAU - Papa, V AU - Papa V FAU - Russo, S AU - Russo S FAU - Di Bella, A AU - Di Bella A FAU - Pabst, G AU - Pabst G FAU - Milazzo, G AU - Milazzo G FAU - Balestrazzi, A AU - Balestrazzi A FAU - Caporossi, A AU - Caporossi A CN - Naproxen Study Group LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - Eur J Ophthalmol JT - European journal of ophthalmology JID - 9110772 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 144O8QL0L1 (Diclofenac) RN - 57Y76R9ATQ (Naproxen) SB - IM MH - Administration, Topical MH - Adult MH - Aged MH - Aged, 80 and over MH - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/adverse effects MH - Diclofenac/*administration & dosage/adverse effects MH - Double-Blind Method MH - Female MH - Humans MH - Inflammation/prevention & control MH - Lens Implantation, Intraocular MH - Male MH - Middle Aged MH - Naproxen/*administration & dosage/adverse effects MH - *Phacoemulsification MH - Postoperative Complications/*prevention & control MH - Prospective Studies MH - Treatment Outcome MH - Uveitis, Anterior/*prevention & control EDAT- 2005/09/17 09:00 MHDA- 2005/11/05 09:00 CRDT- 2005/09/17 09:00 PHST- 2005/09/17 09:00 [pubmed] PHST- 2005/11/05 09:00 [medline] PHST- 2005/09/17 09:00 [entrez] PST - ppublish SO - Eur J Ophthalmol. 2005 Sep-Oct;15(5):598-606.