Efficacy of bromfenac sodium ophthalmic solution for treatment of dry eye disease

To evaluate the efficacy of bromfenac sodium ophthalmic solution (BF) in patients with dry eye disease (DED) inadequately controlled by monotherapy with artificial tears (ATs).

An investigator-oriented trial with a single-arm, nonrandomized, open-label design.

Twenty-six patients, who showed no symptomatic improvement of DED after 1 month of AT treatment, were enrolled. Bromfenac sodium ophthalmic solution was administered adjunctively with AT for 1 month. The BF treatment was then discontinued, and AT treatment alone was continued for 3 months. The signs and symptoms were evaluated at the beginning of BF treatment (Pre), at the end of the combined BF and AT treatment (BF1M), and at 1 and 3 months after discontinuation of BF treatment (Po1M and Po3M, respectively).

The dryness scores at BF1M were significantly improved compared with Pre (P < 0.001) and significantly superior to Po3M (P < 0.001). No significant changes in the Schirmer scores were observed throughout the treatment period. The tear film breakup time was significantly improved at BF1M (4.4 ± 2.3 seconds) compared with Pre (2.8 ± 1.8 seconds; P < 0.001). Superficial punctate keratopathy showed significant improvements in the total score of area and density at BF1M compared with Pre (P < 0.001). However, these parameters had significantly worsened at Po3M compared with BF1M. No adverse events were observed.

Bromfenac sodium ophthalmic solution has improved the dryness of the eye and signs of DED through its anti-inflammatory effects. Nonsteroidal anti-inflammatory drugs were suitable as anti-inflammatory ophthalmic solutions for patients with DED.