Hiroshi Fujishima1, Miki Fuseya, Masarou Ogata, Dogru Murat. 1. From the *Department of Ophthalmology, Tsurumi University School of Dental Medicine, Kanagawa; and †Department of Ophthalmology, Tokyo Saiseikai Central Hospital; and ‡J&J Ocular Surface and Visual Optics Department, Keio University School of Medicine, Tokyo, Japan.
Abstract
PURPOSE: 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). DESIGN: An investigator-oriented trial with a single-arm, nonrandomized, open-label design. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.
PURPOSE: 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). DESIGN: An investigator-oriented trial with a single-arm, nonrandomized, open-label design. METHODS: 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). RESULTS: 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. CONCLUSIONS: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.
Authors: Jiawei Ling; Ben Chung-Lap Chan; Miranda Sin-Man Tsang; Xun Gao; Ping Chung Leung; Christopher Wai-Kei Lam; Jiang-Miao Hu; Chun Kwok Wong Journal: Front Med (Lausanne) Date: 2022-01-17