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Volumn 33, Issue 3, 2012, Pages 265-274

Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis

Author keywords

[No Author keywords available]

Indexed keywords

EYE DROPS; PLACEBO;

EID: 84862564039     PISSN: 10885412     EISSN: 15396304     Source Type: Journal    
DOI: 10.2500/aap.2012.33.3570     Document Type: Article
Times cited : (8)

References (44)
  • 1
    • 34248998743 scopus 로고    scopus 로고
    • Keys to successful management of patients with allergic rhinitis: Focus on patient confidence, compliance, and satisfaction
    • Marple BF, Fornadley JA, Patel AA, et al. Keys to successful management of patients with allergic rhinitis: Focus on patient confidence, compliance, and satisfaction. Otolaryngol Head Neck Surg 136:S107-S124, 2007.
    • (2007) Otolaryngol Head Neck Surg , vol.136
    • Marple, B.F.1    Fornadley, J.A.2    Patel, A.A.3
  • 2
    • 35248871980 scopus 로고    scopus 로고
    • A survey of the burden of allergic rhinitis in the USA
    • Schatz M. A survey of the burden of allergic rhinitis in the USA. Allergy 62(suppl 85):9-16, 2007.
    • (2007) Allergy , vol.62 , Issue.SUPPL. 85 , pp. 9-16
    • Schatz, M.1
  • 3
    • 77958111854 scopus 로고    scopus 로고
    • Allergic and mixed rhinitis: Epidemiology and natural history
    • Bernstein JA. Allergic and mixed rhinitis: Epidemiology and natural history. Allergy Asthma Proc 31:365-369, 2010.
    • (2010) Allergy Asthma Proc , vol.31 , pp. 365-369
    • Bernstein, J.A.1
  • 4
    • 0034544915 scopus 로고    scopus 로고
    • Allergic and immunologic disorders of the eye. Part II: Ocular allergy
    • Bielory L. Allergic and immunologic disorders of the eye. Part II: Ocular allergy. J Allergy Clin Immunol 106:1019-1032, 2000.
    • (2000) J Allergy Clin Immunol , vol.106 , pp. 1019-1032
    • Bielory, L.1
  • 5
    • 0035404659 scopus 로고    scopus 로고
    • Demographics and epidemiology of allergic and nonallergic rhinitis
    • Settipane RA. Demographics and epidemiology of allergic and nonallergic rhinitis. Allergy Asthma Proc 22:185-189, 2001.
    • (2001) Allergy Asthma Proc , vol.22 , pp. 185-189
    • Settipane, R.A.1
  • 6
    • 70449558763 scopus 로고    scopus 로고
    • The management of allergic eye diseases in primary eye care
    • Chigbu DI. The management of allergic eye diseases in primary eye care. Cont Lens Anterior Eye 32:260-272, 2009.
    • (2009) Cont Lens Anterior Eye , vol.32 , pp. 260-272
    • Chigbu, D.I.1
  • 7
    • 77952240308 scopus 로고    scopus 로고
    • Allergic conjunctivitis and the impact of allergic rhinitis
    • Bielory L. Allergic conjunctivitis and the impact of allergic rhinitis. Curr Allergy Asthma Rep 10:122-134, 2010.
    • (2010) Curr Allergy Asthma Rep , vol.10 , pp. 122-134
    • Bielory, L.1
  • 8
    • 77957785452 scopus 로고    scopus 로고
    • The epidemiology of ocular and nasal allergy in the United States, 1988-1994
    • Singh K, Axelrod S, and Bielory L. The epidemiology of ocular and nasal allergy in the United States, 1988-1994. J Allergy Clin Immunol 126:778-783, 2010.
    • (2010) J Allergy Clin Immunol , vol.126 , pp. 778-783
    • Singh, K.1    Axelrod, S.2    Bielory, L.3
  • 9
    • 0028808146 scopus 로고
    • Results of a survey of patients with ocular allergy treated with topical ketorolac tromethamine
    • Raizman MB. Results of a survey of patients with ocular allergy treated with topical ketorolac tromethamine. Clin Ther 17:882-890, 1995.
    • (1995) Clin Ther , vol.17 , pp. 882-890
    • Raizman, M.B.1
  • 10
    • 0035804276 scopus 로고    scopus 로고
    • Allergy and allergic diseases. First of two parts
    • Kay AB. Allergy and allergic diseases. First of two parts. N Engl J Med 344:30-37, 2001.
    • (2001) N Engl J Med , vol.344 , pp. 30-37
    • Kay, A.B.1
  • 11
    • 4544365651 scopus 로고    scopus 로고
    • Ocular allergic disease: Mechanisms, disease sub-types, treatment
    • Abelson MB, Smith L, and Chapin M. Ocular allergic disease: Mechanisms, disease sub-types, treatment. Ocul Surf 1:127-149, 2003.
    • (2003) Ocul Surf , vol.1 , pp. 127-149
    • Abelson, M.B.1    Smith, L.2    Chapin, M.3
  • 12
    • 77958112424 scopus 로고    scopus 로고
    • Allergic rhinitis: Pathophysiology
    • Broide DH. Allergic rhinitis: Pathophysiology. Allergy Asthma Proc 31:370-374, 2010.
    • (2010) Allergy Asthma Proc , vol.31 , pp. 370-374
    • Broide, D.H.1
  • 13
    • 84873074032 scopus 로고    scopus 로고
    • Chapter 4: Anaphylaxis and allergy
    • ed. 5. Malden, MA: Blackwell Publishing
    • Chapel H, Haeney M, Mishba S, et al. (Eds). Chapter 4: Anaphylaxis and allergy. In Essentials of Clinical Immunology, ed. 5. Malden, MA: Blackwell Publishing, 78-94, 2007.
    • (2007) Essentials of Clinical Immunology , pp. 78-94
    • Chapel, H.1    Haeney, M.2    Mishba, S.3
  • 14
    • 0012463884 scopus 로고    scopus 로고
    • Chapter 19: Immediate hypersensitivity
    • ed. 6. Philadelphia, PA: Saunders Elsevier
    • Abbas AK, Lichtman AH, and Pillai S (Eds). Chapter 19: Immediate hypersensitivity. In Cellular and Molecular Immunology, ed. 6. Philadelphia, PA: Saunders Elsevier, 441-461, 2010.
    • (2010) Cellular and Molecular Immunology , pp. 441-461
    • Abbas, A.K.1    Lichtman, A.H.2    Pillai, S.3
  • 15
    • 84862567610 scopus 로고    scopus 로고
    • Chapter 1: Immunology of allergic and clinical immunologic disorders
    • ed. 3. Fireman P (Ed). Philadelphia, PA: Mosby Elsevier
    • Petrov A, and Fireman P. Chapter 1: Immunology of allergic and clinical immunologic disorders. In Atlas of Allergies and Clinical Immunology, ed. 3. Fireman P (Ed). Philadelphia, PA: Mosby Elsevier, 1-33, 2006.
    • (2006) Atlas of Allergies and Clinical Immunology , pp. 1-33
    • Petrov, A.1    Fireman, P.2
  • 16
    • 79960729755 scopus 로고    scopus 로고
    • Chapter 5: The role of histamine in ocular allergy
    • Thurmond RL (Ed). New York, NY: Landes Bioscience and Springer Science+Business Media
    • Ohbayashi M, Manzouri B, Morohoshi K, et al. Chapter 5: The role of histamine in ocular allergy. In Histamine in Inflammation. Thurmond RL (Ed). New York, NY: Landes Bioscience and Springer Science+Business Media, 43-52, 2010.
    • (2010) Histamine in Inflammation , pp. 43-52
    • Ohbayashi, M.1    Manzouri, B.2    Morohoshi, K.3
  • 17
    • 0033694389 scopus 로고    scopus 로고
    • Tear and conjunctival changes during the allergen-induced early- and late-phase responses
    • Bacon AS, Ahluwalia P, Irani AM, et al. Tear and conjunctival changes during the allergen-induced early- and late-phase responses. J Allergy Clin Immunol 106:948-954, 2000.
    • (2000) J Allergy Clin Immunol , vol.106 , pp. 948-954
    • Bacon, A.S.1    Ahluwalia, P.2    Irani, A.M.3
  • 18
    • 0033626457 scopus 로고    scopus 로고
    • An evaluation of onset and duration of action of patanol (olopatadine hydrochloride ophthalmic solution 0.1%) compared to Claritin (loratadine 10 mg) tablets in acute allergic conjunctivitis in the conjunctival allergen challenge model
    • Abelson MB, and Welch DL. An evaluation of onset and duration of action of patanol (olopatadine hydrochloride ophthalmic solution 0.1%) compared to Claritin (loratadine 10 mg) tablets in acute allergic conjunctivitis in the conjunctival allergen challenge model. Acta Ophthalmol Scand Suppl 78:60-63, 2000.
    • (2000) Acta Ophthalmol Scand Suppl , vol.78 , pp. 60-63
    • Abelson, M.B.1    Welch, D.L.2
  • 20
    • 0031692134 scopus 로고    scopus 로고
    • Antiallergic action of betotastine besilate (TAU-284) in animal models: A comparison with ketotifen
    • Ueno M, Inagaki N, Nagai H, et al. Antiallergic action of betotastine besilate (TAU-284) in animal models: a comparison with ketotifen. Pharmacology 57:206-214, 1998.
    • (1998) Pharmacology , vol.57 , pp. 206-214
    • Ueno, M.1    Inagaki, N.2    Nagai, H.3
  • 21
    • 0030770704 scopus 로고    scopus 로고
    • Effects of the new allergy drug betotastine besilate (TAU-284) on experimental allergic rhinitis
    • in Japanese
    • Murata T, Matsumoto Y, Suzuki T, et al. Effects of the new allergy drug betotastine besilate (TAU-284) on experimental allergic rhinitis [in Japanese]. Allergy 46:576-584, 1997.
    • (1997) Allergy , vol.46 , pp. 576-584
    • Murata, T.1    Matsumoto, Y.2    Suzuki, T.3
  • 22
    • 72149130899 scopus 로고    scopus 로고
    • Late phase II clinical study of TAU-284 for perennial allergic rhinitis - Dose finding study by the double-blind method
    • in Japanese
    • Baba S, Takasaki T, Baba K, et al. Late phase II clinical study of TAU-284 for perennial allergic rhinitis - Dose finding study by the double-blind method [in Japanese]. J Clin Ther Med 13:1259-1286, 1997.
    • (1997) J Clin Ther Med , vol.13 , pp. 1259-1286
    • Baba, S.1    Takasaki, T.2    Baba, K.3
  • 23
    • 67649312831 scopus 로고    scopus 로고
    • Long-term treatment of TAU-284 (betotastine besilate) on perennial allergic rhinitis
    • in Japanese
    • Baba S, Takasaka T, Baba K, et al. Long-term treatment of TAU-284 (betotastine besilate) on perennial allergic rhinitis [in Japanese]. J Clin Ther Med 13:1361-1382, 1997.
    • (1997) J Clin Ther Med , vol.13 , pp. 1361-1382
    • Baba, S.1    Takasaka, T.2    Baba, K.3
  • 24
    • 72149106123 scopus 로고    scopus 로고
    • Late phase II study of TAU-284 (betotastine besialte) on chronic urticaria - Optimal dose finding study by double-blind technique
    • in Japanese
    • Ishibashi Y, Harada S, Niimura M, et al. Late phase II study of TAU-284 (betotastine besialte) on chronic urticaria - Optimal dose finding study by double-blind technique [in Japanese]. J Clin Ther Med 13:1237-1257, 1997.
    • (1997) J Clin Ther Med , vol.13 , pp. 1237-1257
    • Ishibashi, Y.1    Harada, S.2    Niimura, M.3
  • 25
    • 72149104776 scopus 로고    scopus 로고
    • Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solutions 1.0% and 1.5% in allergic conjunctivitis: A phase III, single-center, prospective, randomized, double-masked, placebo-controlled, conjunctival allergen challenge assessment in adults and children
    • Abelson MB, Torkildsen GL, Williams JI, et al. Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solutions 1.0% and 1.5% in allergic conjunctivitis: A phase III, single-center, prospective, randomized, double-masked, placebo-controlled, conjunctival allergen challenge assessment in adults and children. Clin Ther 31:1908-1921, 2009.
    • (2009) Clin Ther , vol.31 , pp. 1908-1921
    • Abelson, M.B.1    Torkildsen, G.L.2    Williams, J.I.3
  • 26
    • 77953911802 scopus 로고    scopus 로고
    • Multicenter clinical evaluation of bepotastine besilate ophthalmic solutions 1.0% and 1.5% to treat allergic conjunctivitis
    • Macejko TT, Bergmann MT, Williams JI, et al. Multicenter clinical evaluation of bepotastine besilate ophthalmic solutions 1.0% and 1.5% to treat allergic conjunctivitis. Am J Ophthalmol 150:122-127, 2010.
    • (2010) Am J Ophthalmol , vol.150 , pp. 122-127
    • Macejko, T.T.1    Bergmann, M.T.2    Williams, J.I.3
  • 27
    • 79952830795 scopus 로고    scopus 로고
    • Critical appraisal of bepotastine in the treatment of ocular itching associated with allergic conjunctivitis
    • Wingard JB, and Mah FS. Critical appraisal of bepotastine in the treatment of ocular itching associated with allergic conjunctivitis. Clin Ophthalmol 5:201-207, 2011.
    • (2011) Clin Ophthalmol , vol.5 , pp. 201-207
    • Wingard, J.B.1    Mah, F.S.2
  • 28
    • 77956770486 scopus 로고    scopus 로고
    • Non-clinical pharmacology, pharmacokinetics, and safety findings for the antihistamine bepotastine besilate
    • Williams JI, Gow JA, Klier SM, et al. Non-clinical pharmacology, pharmacokinetics, and safety findings for the antihistamine bepotastine besilate. Curr Med Res Opin 26:2329-2338, 2010.
    • (2010) Curr Med Res Opin , vol.26 , pp. 2329-2338
    • Williams, J.I.1    Gow, J.A.2    Klier, S.M.3
  • 29
    • 77953363761 scopus 로고    scopus 로고
    • Bepotastine besilate, a highly selective histamine H1 receptor antagonist, suppresses vascular hyperpermeability and eosinophil recruitment in in vitro and in vivo experimental allergic conjunctivitis models
    • Kida T, Atsuko F, Sakai O, et al. Bepotastine besilate, a highly selective histamine H1 receptor antagonist, suppresses vascular hyperpermeability and eosinophil recruitment in in vitro and in vivo experimental allergic conjunctivitis models. Exp Eye Res 91:85-91, 2010.
    • (2010) Exp Eye Res , vol.91 , pp. 85-91
    • Kida, T.1    Atsuko, F.2    Sakai, O.3
  • 30
    • 0030821786 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamics evaluation of central effect of the novel antiallergic agent betotastine besilate
    • Kato M, Nishida A, Aga Y, et al. Pharmacokinetic and pharmacodynamics evaluation of central effect of the novel antiallergic agent betotastine besilate. Drug Res 47:1116-1124, 1997.
    • (1997) Drug Res , vol.47 , pp. 1116-1124
    • Kato, M.1    Nishida, A.2    Aga, Y.3
  • 31
    • 0030835507 scopus 로고    scopus 로고
    • Anti-allergic activity of betotastine besilate (TAU-284), a new anti-allergic drug
    • Yato N, Murata T, Saito N, et al. Anti-allergic activity of betotastine besilate (TAU-284), a new anti-allergic drug. Folia Pharmacol Jpn 110:19-29, 1997.
    • (1997) Folia Pharmacol Jpn , vol.110 , pp. 19-29
    • Yato, N.1    Murata, T.2    Saito, N.3
  • 32
    • 72149124456 scopus 로고    scopus 로고
    • Early phase II study of TAU-284 (betotastine besilate) on perennial allergic rhinitis
    • in Japanese
    • Baba S, Sakakura Y, Iwata S, et al. Early phase II study of TAU-284 (betotastine besilate) on perennial allergic rhinitis [in Japanese]. J Clin Ther Med 13:1217-1235, 1997.
    • (1997) J Clin Ther Med , vol.13 , pp. 1217-1235
    • Baba, S.1    Sakakura, Y.2    Iwata, S.3
  • 33
    • 84862525002 scopus 로고    scopus 로고
    • Tanabe Seiyaku Co., Ltd. Osaka, Japan; October
    • Tanabe Seiyaku Co., Ltd. Talion package insert. Osaka, Japan; October 2009.
    • (2009) Talion Package Insert
  • 34
    • 72149084888 scopus 로고    scopus 로고
    • Efficacy and safety investigation of bepotastine besilate (Talion tablets) in patients with atopic dermatitis
    • in Japanese
    • Kawana S, Niimi Y, Higashi N, et al. Efficacy and safety investigation of bepotastine besilate (Talion tablets) in patients with atopic dermatitis [in Japanese]. J New Rem Clin 54:1325-1331, 2005.
    • (2005) J New Rem Clin , vol.54 , pp. 1325-1331
    • Kawana, S.1    Niimi, Y.2    Higashi, N.3
  • 35
    • 33750282215 scopus 로고    scopus 로고
    • Immediate clinical effectiveness of bepotastine besilate on urticaria
    • in Japanese
    • Koda F, and Furue M. Immediate clinical effectiveness of bepotastine besilate on urticaria [in Japanese]. Nishinihon J Dermatol 68:544-547, 2006.
    • (2006) Nishinihon J Dermatol , vol.68 , pp. 544-547
    • Koda, F.1    Furue, M.2
  • 36
    • 72149086901 scopus 로고    scopus 로고
    • Early phase II study of TAU-284 (Betotastine besilate) on chronic urticaria
    • in Japanese
    • Ishibashi Y, Harada S, Niimura M, et al. Early phase II study of TAU-284 (Betotastine besilate) on chronic urticaria [in Japanese]. J Clin Ther Med 13:1199-1215, 1997.
    • (1997) J Clin Ther Med , vol.13 , pp. 1199-1215
    • Ishibashi, Y.1    Harada, S.2    Niimura, M.3
  • 37
    • 72149119964 scopus 로고    scopus 로고
    • Long-term treatment of TAU-284 (betotastine besilate) on chronic urticaria
    • in Japanese
    • Ishibashi Y, Harada S, Niimura M, et al. Long-term treatment of TAU-284 (betotastine besilate) on chronic urticaria [in Japanese]. J Clin Ther Med 13:1337-1359, 1997.
    • (1997) J Clin Ther Med , vol.13 , pp. 1337-1359
    • Ishibashi, Y.1    Harada, S.2    Niimura, M.3
  • 38
    • 33748574073 scopus 로고    scopus 로고
    • Clinical evaluation of TAU-284 (Betotastine Besilate) on eczema/dermatitis, prurigo and pruritus cutaneus
    • in Japanese
    • Ishibashi Y, Harada S, Niimura, et al. Clinical evaluation of TAU-284 (Betotastine Besilate) on eczema/dermatitis, prurigo and pruritus cutaneus [in Japanese]. J Clin Ther Med 13:1383-1400, 1997.
    • (1997) J Clin Ther Med , vol.13 , pp. 1383-1400
    • Ishibashi, Y.1    Niimura, H.S.2
  • 39
    • 0025166468 scopus 로고
    • Conjunctival allergen challenge: A clinical approach to studying allergic conjunctivitis
    • Abelson MB, Chambers WA, and Smith LM. Conjunctival allergen challenge: A clinical approach to studying allergic conjunctivitis. Arch Ophthalmol 108:84-88, 1990.
    • (1990) Arch Ophthalmol , vol.108 , pp. 84-88
    • Abelson, M.B.1    Chambers, W.A.2    Smith, L.M.3
  • 40
    • 0043237253 scopus 로고    scopus 로고
    • Conjunctival allergen challenge: Models in the investigation of ocular allergy
    • Abelson MB, and Loeffler O. Conjunctival allergen challenge: Models in the investigation of ocular allergy. Curr Allergy Asthma Rep 3:363-368, 2003.
    • (2003) Curr Allergy Asthma Rep , vol.3 , pp. 363-368
    • Abelson, M.B.1    Loeffler, O.2
  • 41
    • 0031700446 scopus 로고    scopus 로고
    • The conjunctival provocation test model of ocular allergy: Utility for assessment of an ocular corticosteroid, loteprednol etabonate
    • Abelson M, Howes J, and George M. The conjunctival provocation test model of ocular allergy: Utility for assessment of an ocular corticosteroid, loteprednol etabonate. J Ocul Pharmacol Ther 14:533-542, 1998.
    • (1998) J Ocul Pharmacol Ther , vol.14 , pp. 533-542
    • Abelson, M.1    Howes, J.2    George, M.3
  • 42
    • 0032100735 scopus 로고    scopus 로고
    • Combined analysis of two studies using the conjunctival allergen challenge model to evaluate olopatadine hydrochloride, a new ophthalmic antiallergic agent with dual activity
    • Abelson MB, and Spitalny L. Combined analysis of two studies using the conjunctival allergen challenge model to evaluate olopatadine hydrochloride, a new ophthalmic antiallergic agent with dual activity. Am J Ophthalmol 125:797-804, 1998.
    • (1998) Am J Ophthalmol , vol.125 , pp. 797-804
    • Abelson, M.B.1    Spitalny, L.2
  • 43
    • 79961188988 scopus 로고    scopus 로고
    • Prolonged effectiveness of bepotastine besilate ophthalmic solution for the treatment of ocular symptoms of allergic conjunctivitis
    • Williams JI, Kennedy KS, Gow JA, et al. Prolonged effectiveness of bepotastine besilate ophthalmic solution for the treatment of ocular symptoms of allergic conjunctivitis. J Ocul Pharmacol Ther 27:385-393, 2011.
    • (2011) J Ocul Pharmacol Ther , vol.27 , pp. 385-393
    • Williams, J.I.1    Kennedy, K.S.2    Gow, J.A.3
  • 44
    • 84873064343 scopus 로고    scopus 로고
    • Irvine, CA: ISTA Pharmaceuticals, Inc
    • BEPREVE [package insert]. Irvine, CA: ISTA Pharmaceuticals, Inc; www.bepreve.com/assets/pdfs/Bepreve-Full-PI.pdf; 2010.
    • (2010) BEPREVE [Package Insert]


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