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Ophthalmology 2012;119:2471–2478 R3 이지영/Pf.정성근 • decreased tear production . tear film • altered tear composition . • damages the ocular surface . instability . dry eye tear film lipid layer Aqueous layer Mucin • important lubrication • defense functions on the ocular surface • retention of the aqueous layer quinolinone derivative Increasing mucin levels in the stomach ▪ effective in the treatment of gastric ulcers and gastritis in humans Increases the production of mucin-like substances in the cornea and conjunctiva ▪ improve damage to the ocular surface of patients with dry eye Objective To investigate the dose response for efficacy of 1% and 2% rebamipide ophthalmic suspension compared with placebo in patients with dry eye Study Design randomized, double-masked, placebo-controlled, multicenter, parallel-group, dose-response, phase II study 308 patients with dry eye 1 % rebamipide 2% rebamipide placebo n = 99 n= 101 n= 103 After a 2-week screening period, patients were randomized to receive placebo or 1% rebamipide or 2% rebamipide administered as 1 drop in each eye 4 times daily for 4 weeks. Patients Inclusion criteria ▪ aged ≥ 20 years ▪ dry eye–related symptoms that were not fully relieved by conventional treatments ▪ present for >20 months ▪ other criteria ▪ ▪ ▪ ▪ ▪ (1) score of 2 for 1 or more dry eye–related ocular symptoms (2) fluorescein corneal staining (FCS) score 4 (3) lissamine green conjunctival staining (LGCS) score 5 (4) unanesthetized Schirmer’s test value at 5 minutes 5mm (5) corrected visual acuity 20/100 exclusion criteria ▪ ▪ ▪ ▪ anterior ocular disease (e.g., blepharitis or blepharospasm) punctal plug or removed within 3 months operation to the ocular surface within 12 months intraocular surgery within the 3 months Outcome Measures • change from baseline in fluorescein corneal staining (FCS) score • lissamine green conjunctival staining (LGCS) score • TBUT • Schirmer’s test • dry eye–related ocular symptoms score • patients’ overall treatment impression score Primary objective end point Secondary objective end point Secondary subjective end points baseline, week 2, and week 4, or at discontinuation Change from baseline in FCS score • 1% and 2% rebamipide groups significantly greater than the placebo group at week 2, week 4, and LOCF • Treatment effects were greater in the 2 % rebamipide group for those with a baseline FCS score 10 – 15 dose response change from baseline in LGCS score • 1% and 2% rebamipide groups was significantly larger than in the placebo group at week 2, week 4, and LOCF Patients’ Overall Treatment Impressions • significant improvement in patients’ overall treatment impressions in both the 1% and 2% rebamipide groups The objective signs and subjective symptoms were significantly improved in patients receiving rebamipide versus placebo. Dysgeusia was the most frequently observed drugrelated adverse event in the rebamipide groups, although all events were mild and resolved without treatment. Rebamipide, which increases the mucin level of a natural component of the tear film, is an effective treatment for dry eye, with improvements in as early as 2 weeks. 2% rebamipide may be more effective than 1% rebamipide in severe dry eye. Rebamipide increasing mucin in the cornea and conjunctiva relief of dry eye symptoms and objective sign Side effect Dysgeusia : bitter taste associated with the active ingredient rebamipide