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著者: Stephen C Pflugfelder, Steven L Maskin, Bruce Anderson, James Chodosh, Edward J Holland, Cintia S De Paiva, Stephen P Bartels, Teresa Micuda, Howard M Proskin, Roger Vogel
雑誌名: Am J Ophthalmol. 2004 Sep;138(3):444-57. doi: 10.1016/j.ajo.2004.04.052.
Abstract/Text
PURPOSE: To evaluate loteprednol etabonate ophthalmic 0.5% suspension, versus placebo for treatment of the inflammatory component of keratoconjunctivitis sicca in patients with delayed tear clearance.
DESIGN: Randomized, double-masked, placebo-controlled clinical trial.
METHODS: Sixty-four patients with keratoconjunctivitis sicca and delayed tear clearance were randomly assigned to receive either loteprednol or vehicle 4 times a day for 4 weeks. Patients were evaluated at weeks 2 and 4 of treatment and 2 weeks after treatment was discontinued. Symptoms were scored using a visual analog scale (VAS) of 1 to 100. Corneal fluorescein staining was scored 0 to 4 in five areas. Conjunctival injection was graded 0 to 3 in the inferior bulbar, nasal bulbar, and inferior tarsal areas. Lid margin injection was graded 0 to 3. Safety was assessed by funduscopy, lens examination, biomicroscopy, visual acuity, and Goldmann tonometry, and by monitoring adverse events and changes in symptoms.
RESULTS: In subsets of patients with at least moderate clinical inflammation, there was a significant difference between the loteprednol-treated group and vehicle-treated group after 2 weeks of therapy. The differences did not reach statistical significance at 4 weeks, although the loteprednol-treated patients retained their improvement compared with the vehicle-treated group. Safety evaluations showed both treatments to be well tolerated and similar in the frequency and type of adverse event reported.
CONCLUSION: The use of topical loteprednol etabonate 0.5% 4 times a day may be beneficial in patients who have keratoconjunctivitis sicca with at least a moderate inflammatory component.
PMID 15364229 Am J Ophthalmol. 2004 Sep;138(3):444-57. doi: 10.1016/j.ajo.2004.04.052.
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