Ocufen (flurbiprofen) in the treatment of ocular pain after radial keratotomy.

Author(s): Gwon A, Vaughan ER, Cheetham JK, DeGryse R

Affiliation(s): Allergan Pharmaceuticals, Inc., Irvine, CA.

Publication date & source: 1994-04, CLAO J., 20(2):131-8.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

Ocular pain is often treated with systemic analgesics, which are associated with some undesirable side effects. Because nonsteroidal anti-inflammatory drugs are thought to be peripheral analgesics, we decided to evaluate the local analgesic effect of flurbiprofen. After an initial study in 29 patients demonstrated that 0.03% flurbiprofen ophthalmic solution did not affect corneal sensitivity, a second trial was designed to test the analgesic efficacy and safety of this agent. In a multicenter, randomized, double-masked, parallel-group clinical trial, topically applied 0.03% flurbiprofen sodium ophthalmic solution was compared with its vehicle in 105 patients (53 females, 52 males) undergoing elective unilateral radial keratotomy. All patients received flurbiprofen or its vehicle before and every four hours after surgery for 14 days. Mean pain intensity variables were lower in the flurbiprofen group than the vehicle group after surgery. Clinically significant differences in pain relief (mean difference > or = 1 unit), favoring flurbiprofen, were seen at hours 2, 3, and 4, and on days 1 through 4, and on day 7. Statistically significant differences were seen at hours 2, 3, and 4. Sixteen patients (eight in each group) had adverse effects, most commonly transient burning. These studies suggest that topical 0.03% flurbiprofen safely and effectively relieves ocular pain without affecting corneal sensation.