Topical nonsteroidal anti-inflammatory drugs in uncomplicated cataract surgery: effect of sodium naproxen.

Abstract

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.

• Authors: P Russo, V Papa, S Russo, A Di Bella, G Pabst, G Milazzo, A Balestrazzi, A Caporossi, Naproxen Study Group
• Journal: European journal of ophthalmology (Eur J Ophthalmol) 2005 Sep-Oct Vol. 15 Issue 5 Pg. 598-606 ISSN: 1120-6721 [Print] United States
• PMID: 16167290 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Diclofenac
• Naproxen

Topics

• Administration, Topical
• Adult
• Aged
• Aged, 80 and over
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
• Diclofenac (administration & dosage, adverse effects)
• Double-Blind Method
• Female
• Humans
• Inflammation (prevention & control)
• Lens Implantation, Intraocular
• Male
• Middle Aged
• Naproxen (administration & dosage, adverse effects)
• Phacoemulsification
• Postoperative Complications (prevention & control)
• Prospective Studies
• Treatment Outcome
• Uveitis, Anterior (prevention & control)