Rebamipide (OPC-12759) in the treatment of dry eye: A randomized, double-masked, multicenter, placebo-controlled phase II study

Ophthalmology

Volumn 119, Issue 12, 2012, Pages 2471-2478

  Kinoshita, Shigeru ^a   Awamura, Saki ^b   Oshiden, Kazuhide ^b   Nakamichi, Norihiro ^b   Suzuki, Hiroyuki ^b   Yokoi, Norihiko ^a  

^a KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

^b OTSUKA PHARMACEUTICAL CO LTD   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; REBAMIPIDE;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; DRY EYE; FEMALE; FLUORESCEIN CORNEAL STAINING SCORE; HUMAN; LAST OBSERVATION CARRIED FORWARD; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PARALLEL DESIGN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHIRMER TEST; TEAR FILM BREAK UP TIME; TREATMENT OUTCOME; VISUAL SYSTEM EXAMINATION;

ADULT; AGED; AGED, 80 AND OVER; ALANINE; ANTIOXIDANTS; COLORING AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRY EYE SYNDROMES; ENZYME INHIBITORS; FEMALE; FLUORESCEIN; FLUOROPHOTOMETRY; HUMANS; LISSAMINE GREEN DYES; MALE; MIDDLE AGED; OPHTHALMIC SOLUTIONS; QUINOLONES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84870704793     PISSN: 01616420     EISSN: 15494713     Source Type: Journal    
DOI: 10.1016/j.ophtha.2012.06.052     Document Type: Article

References (35)

1. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye Workshop (2007) Ocul Surf 5 2007 75 92
2. C.G. Begley, R.L. Chalmers, L. Abetz The relationship between habitual patient-reported symptoms and clinical signs among patients with dry eye of varying severity Invest Ophthalmol Vis Sci 44 2003 4753 4761
3. B. Miljanovic, R. Dana, D.A. Sullivan, D.A. Schaumberg Impact of dry eye syndrome on vision-related quality of life Am J Ophthalmol 143 2007 409 415
4. E. Goto, Y. Yagi, Y. Matsumoto, K. Tsubota Impaired functional visual acuity of dry eye patients Am J Ophthalmol 133 2002 181 186
5. P.Y. Lin, S.Y. Tsai, C.Y. Cheng Prevalence of dry eye among an elderly Chinese population in Taiwan: the Shihpai Eye Study Ophthalmology 110 2003 1096 1101
6. D.A. Schaumberg, D.A. Sullivan, J.E. Buring, M.R. Dana Prevalence of dry eye syndrome among US women Am J Ophthalmol 136 2003 318 326
7. J.J. Nichols, L.T. Sinnott Tear film, contact lens, and patient-related factors associated with contact lens-related dry eye Invest Ophthalmol Vis Sci 47 2006 1319 1328
8. P. Reddy, O. Grad, K. Rajagopalan The economic burden of dry eye: a conceptual framework and preliminary assessment Cornea 23 2004 751 761
9. I.K. Gipson The ocular surface: the challenge to enable and protect vision: the Friedenwald lecture Invest Ophthalmol Vis Sci 48 2007 4390 4391-8
10. N.J. Friedman Impact of dry eye disease and treatment on quality of life Curr Opin Ophthalmol 21 2010 310 316
11. American Academy of Ophthalmology Cornea/External Panel Preferred Practice Pattern Dry eye syndrome: limited revision 2011 American Academy of Ophthalmology San Francisco, CA http://one.aao.org/CE/PracticeGuidelines/PPP. aspx Accessed June 9, 2012
12. T.G. Slusser, G.E. Lowther Effects of lacrimal drainage occlusion with nondissolvable intracanalicular plugs on hydrogel contact lens wear Optom Vis Sci 75 1998 330 338
13. D. Stevenson, J. Tauber, B.L. Reis Cyclosporin A Phase 2 Study Group Efficacy and safety of cyclosporin A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial Ophthalmology 107 2000 967 974
14. K. Sall, O.D. Stevenson, T.K. Mundorf, B.L. Reis CsA Phase 3 Study Group Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease Ophthalmology 107 2000 631 639
15. L. Baiza-Duran, J. Medrano-Palafox, E. Hernandez-Quintela A comparative clinical trial of the efficacy of two different aqueous solutions of cyclosporine for the treatment of moderate-to-severe dry eye syndrome Br J Ophthalmol 94 2010 1312 1315
16. A.P. Corfield, S.D. Carrington, S.J. Hicks Ocular mucins: purification, metabolism and functions Prog Retin Eye Res 16 1997 627 656
17. R.A. Ralph Conjunctival goblet cell density in normal subjects and in dry eye syndromes Invest Ophthalmol 14 1975 299 302
18. T. Shigemitsu, Y. Shimizu, K. Ishiguro Mucin ophthalmic solution treatment of dry eye Adv Exp Med Biol 506 2002 359 362
19. Y. Danjo, H. Watanabe, A.S. Tisdale Alteration of mucin in human conjunctival epithelia in dry eye Invest Ophthalmol Vis Sci 39 1998 2602 2609
20. P. Argueso, M. Balaram, S. Spurr-Michaud Decreased levels of the goblet cell mucin MUC5AC in tears of patients with Sjogren syndrome Invest Ophthalmol Vis Sci 43 2002 1004 1011
21. S.C. Pflugfelder, S.C. Tseng, K. Yoshino Correlation of goblet cell density and mucosal epithelial membrane mucin expression with rose bengal staining in patients with ocular irritation Ophthalmology 104 1997 223 235
22. K. Iijima, T. Ichikawa, S. Okada Rebamipide, a cytoprotective drug, increases gastric mucus secretion in human: evaluations with endoscopic gastrin test Dig Dis Sci 54 2009 1500 1507
23. Y. Naito, T. Yoshikawa Rebamipide: a gastrointestinal protective drug with pleiotropic activities Expert Rev Gastroenterol Hepatol 4 2010 261 270
24. K. Yamasaki, T. Kanbe, T. Chijiwa Gastric mucosal protection by OPC-12759, a novel antiulcer compound, in the rat Eur J Pharmacol 142 1987 23 29
25. H. Urashima, T. Okamoto, Y. Takeji Rebamipide increases the amount of mucin-like substances on the conjunctiva and cornea in the N-acetylcysteine- treated in vivo model Cornea 23 2004 613 619
26. S.J. Pocock, R. Simon Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial Biometrics 31 1975 103 115
27. M.A. Lemp Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eyes CLAO J 21 1995 221 232
28. T. Hikichi, A. Yoshida, Y. Fukui Prevalence of dry eye in Japanese eye centers Graefes Arch Clin Exp Ophthalmol 233 1995 555 558
29. H. Urashima, Y. Takeji, T. Okamoto Rebamipide increases mucin-like substance contents and periodic acid Schiff reagent-positive cells density in normal rabbits J Ocul Pharmacol Ther 28 2012 264 270
30. Y. Takeji, H. Urashima, A. Aoki, H. Shinohara Rebamipide increases the mucin-like glycoprotein production in corneal epithelial cells J Ocul Pharmacol Ther 28 2012 259 263
31. P.A. Asbell, S. Spiegel Ophthalmologist perceptions regarding treatment of moderate-to-severe dry eye: results of a physician survey Eye Contact Lens 36 2010 33 38
32. K.K. Nichols, J.J. Nichols, G.L. Mitchell The lack of association between signs and symptoms in patients with dry eye disease Cornea 23 2004 762 770
33. J.L. Gayton Etiology, prevalence, and treatment of dry eye disease Clin Ophthalmol 3 2009 405 412
34. R. Latkany Dry eyes: etiology and management Curr Opin Ophthalmol 19 2008 287 291
35. A. Peral, C.O. Dominguez-Godinez, G. Carracedo, J. Pintor Therapeutic targets in dry eye syndrome Drug News Perspect 21 2008 166 176