A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo

Summary

The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

Timeline

Start

2004-05-01

Primary completion

2007-02-01

Completion

2007-02-01

Publications

• Background Yamasaki K, Ishiyama H, Imaizumi T, Kanbe T, Yabuuchi Y. Effect of OPC-12759, a novel antiulcer agent, on chronic and acute experimental gastric ulcer, and gastric secretion in rats. Jpn J Pharmacol. 1989 Apr;49(4):441-8. doi: 10.1254/jjp.49.441.
• Background Yamasaki K, Kanbe T, Chijiwa T, Ishiyama H, Morita S. Gastric mucosal protection by OPC-12759, a novel antiulcer compound, in the rat. Eur J Pharmacol. 1987 Oct 6;142(1):23-9. doi: 10.1016/0014-2999(87)90649-2.
• Background Yoshikawa T, Naito Y, Tanigawa T, Kondo M. Free radical scavenging activity of the novel anti-ulcer agent rebamipide studied by electron spin resonance. Arzneimittelforschung. 1993 Mar;43(3):363-6.
• Background Yoshikawa T, Naito Y, Nakamura S, Nishimura S, Kaneko T, Iinuma S, Takahashi S, Kondo M, Yamasaki K. Effect of rebamipide on lipid peroxidation and gastric mucosal injury induced by indometacin in rats. Arzneimittelforschung. 1993 Dec;43(12):1327-30.
• Background Yamasaki K, et al. Effect of OPC 12759 on the production of oxygen-derived free radical from human polymorphonuclear leukocytes. In-house Report No. 004272.
• Background Yamasaki K, et al. Effect of OPC 12759 on gastric mucosal blood flow in rats-determination by the hydrogen gas clearance method. In-house Report No. 003915.
• Background Imaizumi, T, et al. Effect of OPC 12759 and cetraxate on gastric mucosal hemodynamics and oxygen sufficiency in rats-analysis by reflectance spectrophotometry. In-house Report No. 004101.
• Background Garcher C, Bron A, Baudouin C, Bildstein L, Bara J. CA 19-9 ELISA test: a new method for studying mucus changes in tears. Br J Ophthalmol. 1998 Jan;82(1):88-90. doi: 10.1136/bjo.82.1.88.
• Background Danjo Y, Watanabe H, Tisdale AS, George M, Tsumura T, Abelson MB, Gipson IK. Alteration of mucin in human conjunctival epithelia in dry eye. Invest Ophthalmol Vis Sci. 1998 Dec;39(13):2602-9.
• Background Pflugfelder SC, Tseng SC, Yoshino K, Monroy D, Felix C, Reis BL. Correlation of goblet cell density and mucosal epithelial membrane mucin expression with rose bengal staining in patients with ocular irritation. Ophthalmology. 1997 Feb;104(2):223-35. doi: 10.1016/s0161-6420(97)30330-3.
• Background Kinoshita S, Kiorpes TC, Friend J, Thoft RA. Goblet cell density in ocular surface disease. A better indicator than tear mucin. Arch Ophthalmol. 1983 Aug;101(8):1284-7. doi: 10.1001/archopht.1983.01040020286025.
• Background Rivas L, Oroza MA, Perez-Esteban A, Murube-del-Castillo J. Morphological changes in ocular surface in dry eyes and other disorders by impression cytology. Graefes Arch Clin Exp Ophthalmol. 1992;230(4):329-34. doi: 10.1007/BF00165940.
• Background Nelson JD, Wright JC. Conjunctival goblet cell densities in ocular surface disease. Arch Ophthalmol. 1984 Jul;102(7):1049-51. doi: 10.1001/archopht.1984.01040030851031.
• Background Ferris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6.
• Background Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. No abstract available.
• Background Gail M, Simon R. Testing for qualitative interactions between treatment effects and patient subsets. Biometrics. 1985 Jun;41(2):361-72.
• Background Davis CS, Chung Y. Randomization model methods for evaluating treatment efficacy in multicenter clinical trials. Biometrics. 1995 Sep;51(3):1163-74.

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Indications