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

Clinical Therapeutics

Volumn 31, Issue 9, 2009, Pages 1908-1921

  Abelson, Mark B ^a,b,c   Torkildsen, Gail L ^d   Williams, Jon I ^e   Gow, James A ^e   Gomes, Paul J ^a   McNamara, Timothy R ^f  

^a Ora Inc   (United States)

^b SCHEPENS EYE RESEARCH INSTITUTE   (United States)

^c HARVARD MEDICAL SCHOOL   (United States)

^d Andover Eye Associates   (United States)

^e ISTA Pharmaceuticals Inc   (United States)

^f NONE

Author keywords

allergic conjunctivitis; bepotastine besilate; conjunctival allergen challenge; conjunctival hyperemia; ocular itching

Indexed keywords

BETOTASTINE; PLACEBO;

ADULT; AGED; ALLERGIC CONJUNCTIVITIS; ANXIETY; ARTICLE; CHILD; CLINICAL TRIAL; CONJUNCTIVAL HYPEREMIA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYST; DOUBLE BLIND PROCEDURE; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG MECHANISM; DRUG TOLERABILITY; DRUG WITHDRAWAL; ETHNICITY; EYE IRRITATION; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; INTRAOCULAR FOREIGN BODY; INTRAOCULAR PRESSURE; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; OCULAR PRURITUS; OPHTHALMOSCOPY; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHINOPHARYNGITIS; SCHOOL CHILD; SIDE EFFECT; SKIN MANIFESTATION; SKIN TEST; SLIT LAMP; TASTE DISORDER; THORAX DISEASE; TREATMENT DURATION; VISUAL ACUITY;

ADMINISTRATION, TOPICAL; ADOLESCENT; ADULT; AGED; ALLERGENS; ANTI-ALLERGIC AGENTS; CHILD; CONJUNCTIVITIS, ALLERGIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; OPHTHALMIC SOLUTIONS; PIPERIDINES; PROSPECTIVE STUDIES; PRURITUS; PYRIDINES; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 72149104776     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.09.001     Document Type: Article

References (55)

1. Abelson M.B., and Chapin M.J. Current and future topical treatments for ocular allergy. Comp Ophthalmol Update 1 (2000) 303-317
2. Abelson M.B., Smith L., and Chapin M. Ocular allergic disease: Mechanisms, disease sub-types, treatment. Ocu Surf 1 (2003) 127-149
3. Canonica G.W., Ciprandi G., Petzold U., et al. Topical azelastine in perennial allergic conjunctivitis. Curr Med Res Opin 19 (2003) 321-329
4. Berger W., Abelson M.B., Gomes P.J., et al. Effects of adjuvant therapy with 0.1% olopatadine hydrochloride ophthalmic solution on quality of life in patients with allergic rhinitis using systemic or nasal therapy. Ann Allergy Asthma Immunol 95 (2005) 361-371
5. Abelson M.B., Paradis A., et al. Effects of Vasocon-A in the allergen challenge model of acute allergic conjunctivitis. Arch Ophthalmol 108 (1990) 520-524
6. Verin P., Easty D.L., Secchi A., et al. Clinical evaluation of twice-daily emedastine 0.05% eye drops (Emadine eye drops) versus levocabastine 0.05% eye drops in patients with allergic conjunctivitis. Am J Ophthalmol 131 (2001) 691-698
7. Abelson M.B., Berdy G.J., Mundorf T., et al. Pemirolast potassium 0.1% ophthalmic solution is an effective treatment for allergic conjunctivitis: A pooled analysis of two prospective, randomized, double-masked, placebo-controlled, phase III studies. J Ocul Pharmacol Ther 18 (2002) 475-488
8. Shulman D.G. Two mast cell stabilizers, pemirolast potassium 0.1% and nedocromil sodium 2%, in the treatment of seasonal allergic conjunctivitis: A comparative study. Adv Ther. 20 (2003) 31-40
9. Yaylali V., Demirlenk I., Tatlipinar S., et al. Comparative study of 0.1% olopatadine hydrochloride and 0.5% ketorolac tromethamine in the treatment of seasonal allergic conjunctivitis. Acta Ophthalmol Scand 81 (2003) 378-382
10. 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 (1998) 533-542
11. Abelson M.B., 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 (1998) 797-804
12. Abelson M.B., Gomes P., Gomes P., et al. Efficacy and tolerability of ophthalmic epinastine assessed using the conjunctival antigen challenge model in patients with a history of allergic conjunctivitis. Clin Ther 26 (2004) 35-47
13. Abelson M.B., Gomes P.J., Pasquine T., et al. Efficacy of olopatadine ophthalmic solution 0.2% in reducing signs and symptoms of allergic conjunctivitis. Allergy Asthma Proc 28 (2007) 427-433
14. 1-antihistamines. N Engl J Med. 351 (2004) 2203-2217
15. 1 receptor occupancy of orally administered antihistamines, bepotastine and diphenhydramine, measured by PET with 11C-doxepin. Br J Clin Pharmacol 65 (2008) 811-821
16. Kato M., Nishida A., Aga Y., et al. Pharmacokinetic and pharmacodynamic evaluation of central effect of the novel antiallergic agent bepotastine besilate. Arzneimittelforschung 47 (1997) 1116-1124
17. Yato N., Murata T., Saito N., et al. Anti-allergic activity of betotastine besilate (TAU-284), a new antiallergic drug [in Japanese]. Nippon Yakurigaku Zasshi 110 (1997) 19-29
18. Sakai A., Kikuchi M., Yato N., et al. Inhibitory effect of betotastine besilate on antigen-induced airway eosinophil infiltration and peripheral blood eosinophilia in mice. Arzneimittelforschung 47 (1997) 954-958
19. Ukai K., Takeuchi M., Masuda S., et al. Clinical pharmacological study of antiallergic agent TAU-184 (bepotastine besilate)-the effect on counting of eosinophils in nasal discharge, and the patency improvement of nasal cavity [in Japanese]. J Clin Ther Med. 13 (1997) 1401-1412
20. Ueno M., Inagaki N., Nagai H., and Koda A. Antiallergic action of bepotastine besilate (TAU-284) in animal models: A comparison with ketotifen. Pharmacology 57 (1998) 206-214
21. Honda H., Murata K., Hamazaki A., et al. Inhibitory effect on anaphylactic reaction and histamineantagonizing action [in guinea pigs] of betotastine besilate (TAU-284), a novel anti-allergic drug [in Japanese]. Jpn Pharmacol Ther. 25 (1997) 879-888
22. Sakamoto O., Okanari E., and Ueno H. Suppression effects of the novel drug bepotastine besilate (TAU-284) on experimental asthmatic reactions in guinea pigs [in Japanese]. Jpn Pharmacol Ther. 25 (1997) 889-894
23. Andoh T., and Kuraishi Y. Suppression by bepotastine besilate of substance P-induced itch-associated responses through the inhibition of the leukotriene B4 action in mice. Eur J Pharmacol 547 (2006) 59-64
24. Kaminuma O., Ogawa K., Hikkawa H., et al. A novel anti-allergic drug, betotastine besilate, suppresses interleukin-5 production by human peripheral blood mononuclear cells. Biol Pharm Bull. 21 (1998) 411-413
25. Ohashi Y. Immunological study of a second-generation antihistamine - the effects of bepotastine besilate on cytokine production from the peripheral blood mononuclear cells in cedar pollen allergy patients [in Japanese]. Prog Med. 24 (2004) 157-159
26. Narita H., Kikuchi M., Asahi T., et al. General pharmacology of betotastine besilate (TAU-284), a novel antiallergic agent [in Japanese]. Jpn Pharmacol Ther. 25 (1997) 907-924
27. 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 (1997) 1199-1215
28. Ishibashi Y., Harada S., Niimura M., et al. Late phase II study of TAU- 284 (betotastine besilate) on chronic urticaria-optimal dose finding study by double-blind technique [in Japanese]. J Clin Ther Med. 13 (1997) 1237-1257
29. 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 (1997) 1337-1359
30. Ishibashi Y., Harada S., Niimura M., et al. Clinical evaluation of TAU- 284 (betotastine besilate) on eczema/dermatitis, prurigo, and pruritus cutaneus [in Japanese]. J Clin Ther Med. 13 (1997) 1383-1400
31. Adachi J. Investigation of the clinical effects and safety of bepotastine besilate (Talion tablets) on patients with chronic hives [in Japanese]. Prog Med. 24 (2004) 151-155
32. Shikanai K. Investigation of effectiveness and safety of bepotastine besilate (Talion tablets) in cedar pollen allergy [in Japanese]. Prog Med. 22 (2002) 2472-2477
33. Nakagawa S. Treatment for patients with ear pruritus-investigation of antipruritic effects of bepotastine besilate [in Japanese]. J New Rem Clin. 52 (2003) 677-681
34. Maruta H., Nagata M., Koga H., et al. Clinical evaluation of bepotastine besilate (Talion tablets) on chronic urticaria [in Japanese]. J New Rem Clin. 53 (2004) 576-582
35. Tanaka T., Miyazaki S., and Ishikawa K. The usefulness of Talion in relation to nasal congestion in allergic rhinitis [in Japanese]. Prog Med. 24 (2004) 2037-2044
36. 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 (2005) 1325-1331
37. Horikawa T., Harada S., Tamura S., et al. The clinical efficacy of bepotastine besilate in relation to senile dermal pruritus: Usage testing [in Japanese]. Sci Skin. 4 (2005) 475-480
38. Ohta N., Akatsuka N., Saito F., et al. The effect of prophylactic treatment with bepotastine in patients with Japanese cedar pollinosis [in Japanese]. Practica Otologica 95 (2002) 531-537
39. 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 (1997) 1217-1235
40. 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 doubleblind method [in Japanese]. J Clin Ther Med. 13 (1997) 1259-1286
41. Koda F., and Furue M. Immediate clinical effectiveness of bepotastine besilate on urticaria [in Japanese]. Nishinihon J Dermatol. 68 (2006) 544-547
42. Ito M., Akaogi K., Shimizu K.A., et al. A clinical study of anti-allergy drugs in relation to allergic rhinitis [in Japanese]. Allergol Immunol 10 (2003) 1328-1337
43. Furue M., Nakahara T., Uranai Y., et al. The immediate effectiveness of bepotastine besilate [in Japanese]. Jpn J Clin Exp Med. 81 (2004) 1067-1070
44. Baba S. Post-marketing surveillance study of Talion tablets on pediatric allergic rhinitis [in Japanese]. Rinsho Igaku. 18 (2002) 1371-1387
45. Abelson M.B. Evaluation of olopatadine, a new ophthalmic antiallergic agent with dual activity, using the conjunctival allergen challenge model. Ann Allergy Asthma Immunol. 81 (1998) 211-218
46. Abelson M.B., Gomes P.J., Pasquine T., et al. Efficacy of olopatadine ophthalmic solution 0.2% in reducing signs and symptoms of allergic conjunctivitis. Allergy Asthma Proc. 28 (2007) 427-433
47. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline. Guideline for good clinical practice E6. http://www.ich.org Accessed June 23, 2009
48. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 1989 Version. http://www.wma.net/e/policy/b3.htm Accessed June 23, 2009
49. Protzko E.E., Williams J.I., Gow J.A., et al. The safety of the anti-histamine bepotastine besilate ophthalmic solution in a healthy pediatric population from ten to seventeen years of age. Invest Ophthalmol Vis Sci. 50 (2009) 6325 E-Abstract
50. Macejko T.T., McLaurin E.B., Kurata F.K., et al. Bepotastine besilate ophthalmic solution 1.5% reduces ocular itching following dosing in the conjunctival allergen challenge (CAC) model of acute allergic conjunctivitis. Invest Ophthalmol Vis Sci. 50 (2009) 6328 E-Abstract
51. Abelson M.B., Chambers W.A., and Smith L.M. Conjunctival allergen challenge, A clinical approach to studying allergic conjunctivitis. Arch Ophthalmol. 108 (1990) 84-88
52. Abelson M.B. Comparison of the conjunctival allergen challenge model with the environmental model of allergic conjunctivitis. Acta Ophthalmol Scand 228 Suppl (1999) 43-46
53. Abelson M.B., and Loeffler O. Conjunctival allergen challenge: Models in the investigation of ocular allergy. Curr Allergy Asthma Rep. 3 (2003) 363-368
54. Abelson M.B., Chapin M.J., Kapik B.M., and Shams N.B. Efficacy of ketotifen fumarate 0.025% ophthalmic solution compared with placebo in the conjunctival allergen challenge model. Arch Ophthalmol 121 (2003) 626-630
55. Bepreve (bepotastine besilate ophthalmic solution 1.5%) [package insert] (2009), ISTA Pharmaceuticals, Inc, Irvine, Calif