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C  RECHERCHE CLINIQUE



                      51.  Dell SJ, Lowry GM, Northcutt JA, Howes J, Novack GD, Hart K.   hydrochloride 0.1% ophthalmic solution and ketotifen fumarate
                         A randomized, double-masked, placebo-controlled parallel study   0.025% ophthalmic solution in the conjunctival antigen challenge
                         of 0.2% loteprednol etabonate in patients with seasonal allergic   model. Clin Ther 2000;22:826-33.
                         conjunctivitis. J Allergy Clin Immunol 1998;102:251-5.  63.  Williams JI, Kennedy KS, Gow JA, et al. Prolonged effectiveness   BEPREVE™
                      52.  Shulman DG, Lothringer LL, Rubin JM, et coll. A randomized,   of bepotastine besilate ophthalmic solution for the treatment of
                         double-masked, placebo-controlled parallel study of loteprednol   ocular symptoms of allergic conjunctivitis. J Ocul Pharmacol Ther   (bepotastine besilate ophthalmic solution) 1.5% w/v
                         etabonate 0.2% in patients with seasonal allergic conjunctivitis.   2011;27:385-93.
                         Ophthalmology 1999;106:362-9.             64.  Ilyas H, Slonim CB, Braswell GR, Favetta JR, Schulman M. Long-
                      53.  Ballas Z, Blumenthal M, Tinkelman DG, Kriz R, Rupp G. Clinical   term safety of loteprednol etabonate 0.2% in the treatment of
                         evaluation of ketorolac tromethamine 0.5% ophthalmic solution for   seasonal and perennial allergic conjunctivitis. Eye Contact Lens   HELP TREAT THE ITCH
                         the treatment of seasonal allergic conjunctivitis. Surv Ophthalmol   2004;30:10-3.
                         1993;38 Suppl. 141-8.                     65.  Comstock TL, Sheppard JD. Loteprednol etabonate for in-
                      54.  Bielory L. Update on ocular allergy treatment. Expert Opin Pharma-  flammatory conditions of the anterior segment of the eye:                                               1
                         cother 2002;3:541-53.                       Twenty years of clinical experience with a retrometabolically      ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
                      55.  Owen CG, Shah A, Henshaw K, Smeeth L, Sheikh A. Topical   designed corticosteroid. Expert Opin Pharmacother 2018. doi:
                         treatments for seasonal allergic conjunctivitis: systematic review   10.1080/14656566.2018.1439920.
                         and meta-analysis of efficacy and effectiveness. Br J Gen Pract   66.  Tauber J, Raizman MB, Ostrov CS, et coll. A multicenter compari-
                         2004;54:451-6.                              son of the ocular efficacy and safety of diclofenac 0.1% solution
                                                                                                                                                                                                                                      1–4,
                      56.  Abelson MB, Berdy GJ, Mundorf T, Amdahl LD, Graves AL, Pemi-  with that of ketorolac 0.5% solution in patients with acute seasonal   BEPREVE™ demonstrated significant reduction in ocular itching at 3 minutes post CAC *
                         rolast study g. Pemirolast potassium 0.1% ophthalmic solution is an   allergic conjunctivitis. J Ocul Pharmacol Ther 1998;14:137-45.
                         effective treatment for allergic conjunctivitis: a pooled analysis of   67.  Yaylali V, Demirlenk I, Tatlipinar S, et coll. Comparative study of
                         two prospective, randomized, double-masked, placebo-controlled,   0.1% olopatadine hydrochloride and 0.5% ketorolac tromethamine   Ocular itch scores at 3 minutes post CAC (both eyes averaged)
                         phase III studies. J Ocul Pharmacol Ther 2002;18:475-88.  in the treatment of seasonal allergic conjunctivitis. Acta Ophthalmol
                      57.  Allansmith MR, Ross RN. Ocular allergy and mast cell stabilizers.   Scand 2003 Aug;81(4):378-82.
                         Surv Ophthalmol 1986;30:229-44.           68.  Celik T, Turkoglu EB. Comparative evaluation of olopatadine 0.01%                       Study A 2,4                                   Study B 3,4
                      58.  Manzouri B, Flynn TH, Larkin F, Ono SJ, Wyse R. Pharmacotherapy   combined fluorometholone 0.1% treatment versus olopatadine
                         of allergic eye disease. Expert Opin Pharmacother 2006;7:1191-200.  0.01% combined ketorolac 0.4% treatment in patients with acute
                      59.  Leonardi A, Abelson MB. Double-masked, randomized, placebo-  seasonal allergic conjunctivitis. Curr Eye Res 2014;39:42-6.                     1.87
                         controlled clinical study of the mast cell-stabilizing effects of treat-  69.  Wan KH, Chen LJ, Rong SS, Pang CP, Young AL. Topical cyclospo-                                                 1.85
                         ment with olopatadine in the conjunctival allergen challenge model   rine in the treatment of allergic conjunctivitis: a meta-analysis.   2.00  (n = 36)           2.00
                         in humans. Clin Ther 2003;25:2539-52.       Ophthalmology 2013;120:2197-203.                                                    73.8  %                                       78.4  %         (n = 43)
                      60.  Leonardi A, Zafirakis P. Efficacy and comfort of olopatadine versus   70.  Fukushima A, Ohashi Y, Ebihara N, et coll. Therapeutic effects of
                         ketotifen ophthalmic solutions: a double-masked, environmental   0.1% tacrolimus eye drops for refractory allergic ocular diseases   1.50  1.38 †                  1.50        1.45 ‡
                         study of patient preference. Curr Med Res Opin 2004;20:1167-73.  with proliferative lesion or corneal involvement. Br J Ophthalmol
                      61.  Avunduk AM, Tekelioglu Y, Turk A, Akyol N. Comparison of the   2014;98:1023-7.
                         effects of ketotifen fumarate 0.025% and olopatadine HCl 0.1%   71.  Moote W, Kim H. Allergen-specific immunotherapy. Allergy,
                         ophthalmic solutions in seasonal allergic conjunctivities: a 30-day,   asthma, and clinical immunology : official journal of the Canadian   Ocular itch score  1.00  0.49  Ocular itch score  1.00
                         randomized, double-masked, artificial tear substitute-controlled   Society of Allergy and Clinical Immunology. 2011;7 Suppl. 1:S5.                                            0.40
                         trial. Clin Ther 2005;27:1392-402.        72.  Berger WE, Granet DB, Kabat AG. Diagnosis and management of                       (n = 35)
                      62.  Berdy GJ, Spangler DL, Bensch G, Berdy SS, Brusatti RC. A compar-  allergic conjunctivitis in pediatric patients. Allergy Asthma Proc   0.50                     0.50       (n = 43)
                         ison of the relative efficacy and clinical performance of olopatadine   2017;38:16-27.
                                                                                                                                               0.00                                         0.00
                                                                                                                                                        BEPREVE ™        Placebo                      BEPREVE ™        Placebo
                                                                                                                                                                                  †  P <0.001                                  ‡  P <0.0001
                                                                                                                                        •  At Visit 5 (15 minutes after instillation of BEPREVE™ 1.5% w/v), the mean difference in ocular itch score 3 minutes post CAC,
                                                                                                                                         compared to placebo, was 1.4 and 1.5 in Study A 2,4,§  and Study B 3,4,§ , respectively


                                                                                                                                   Indication and clinical use:                          •  BEPREVE™ should not be instilled while wearing contact lenses. BEPREVE™
                                                                                                                                   BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% w/v is indicated for the   contains benzalkonium chloride as a preservative, which may be absorbed by soft
                                                                                                                                   treatment of itching associated with allergic conjunctivitis.  contact lenses. Remove contact lenses prior to instillation; lenses may be reinserted
                                                                                                                                   •  The safety and efficacy of BEPREVE™ has not been established in pediatric patients   10 minutes after the administration of BEPREVE™
                                                                                                                                    under 3 years of age and should not be used in this population  •  BEPREVE™ should not be used in pregnant women unless the benefit to the mother
                                                                                                                                   •  Efficacy of BEPREVE™ in pediatric patients with age <10 was extrapolated from   clearly outweighs the risk to the fetus
                                                                                                                                    clinical trials conducted in pediatric patients with age >10 and in adults  • Caution should be exercised when BEPREVE™ is administered to lactating women
                                                                                                                                   Relevant warnings and precautions:                    For more information:
                                                                                                                                   • BEPREVE™ is for topical ophthalmic use only         Please consult the Product Monograph at http://www.bausch.ca/Portals/59/Files/
                                                                                                                                   •  Do not touch the eyelids or surrounding areas with the dropper tip of bottle and keep   Monograph/Pharma/bepreve-pm-en.pdf for important information relating to adverse
                                                                                                                                    bottle tightly closed when not in use                reactions, drug interactions, and dosing information that has not been discussed in this
                                                                                                                                   • BEPREVE™ should not be used to treat contact lens–related irritation  piece. The Product Monograph is also available by calling 1-888-459-5000.


                                                                                                                                   * CAC = conjunctival allergen challenge
                                                                                                                                   §   Both Studies A and B were phase III, double-masked, randomized, placebo-controlled CAC clinical trials in which patients were assigned to BEPREVE™ or placebo. Analysis used CAC model of allergic
                                                                                                                                    conjunctivitis (i.e., using multiple allergens, both seasonal and perennial). Ocular itching was graded by subjects using a 9-point scale (0–4 U, half units allowed). Primary endpoints included ocular itching with
                                                                                                                                    dose applied bilaterally 15 minutes, 8 hours, and 16 hours prior to challenge (measured 3, 5, and 7 minutes post CAC). 1–4
                                                                                                                                   References: 1. BEPREVE™ (bepotastine besilate ophthalmic solution 1.5%) Product Monograph. Bausch & Lomb Canada Inc.; July 22, 2016. 2. 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 2009;31:1908–21. 3. 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 2010;15:122–7. 4. Data on file, Bausch & Lomb Incorporated, 2008.


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