Comparative evaluation of efficacy and safety of bepotastine besilate 1.5% ophthalmic solution versus olopatadine hydrochloride 0.1% ophthalmic solution in patients with vernal keratoconjunctivitis
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20211652Keywords:
Bepotastine, Efficacy, Olopatadine, Vernal keratoconjunctivitisAbstract
Background: Vernal keratoconjunctivitis (VKC) is a chronic, seasonally exacerbated, allergic ocular inflammation. It affect children and young adults and has male predominance. The first line of treatment often used is dual acting drugs like olopatadine and bepotastine. It combine the immediate histamine receptor antagonism, coupled with mast cell stabilization with other anti-inflammatory properties. The present study was conducted to compare the efficacy and safety of olopatadine 0.1% and bepotastine 1.5% eye drops in VKC patients.
Methods: This was a prospective, open label, randomized and comparative clinical study conducted for 21 days. 65 patients of VKC of 5-15 years of either sex were randomized in two study arm. Arm A, given bepotastine 1.5% and arm B, given olopatadine 0.1% twice daily for 21 days. Symptoms and signs scoring of VKC along with safety assessment were recorded on baseline and at time of follow up on 7th day and 21st day.
Results: After 3 weeks of drug therapy, patients in both arms showed improvement in the symptoms and signs scoring of VKC. There was no statistically significant difference between the two treatment arms. However, improvement in clinical parameters particularly ocular itching, which is the main complaint of patients with VKC was more in bepotastine arm as compared to olopatadine treated arm. Both the drugs were well tolerated without any serious adverse effect.
Conclusions: Both olopatadine and bepotastine were found to be effective in alleviating the clinical symptoms and signs of VKC. However, bepotastine performed better in reducing ocular itch than olopatadine.
References
Rigoli L, Briuglia S, Caimmi S, Ferrau V, Gallizzi R, Leonardi S, et al. Gene-environment interactions in childhood asthma. Int J Immunopathol Pharmacol. 2011;24:41-7.
Maziak W, Behrens T, Brasky TM, Duhme H, Rzehak P, Weiland SK, et al. Are asthma and allergies in children and adolescents increasing. Results from ISAAC phase I and phase III surveys in Munster, Germany. Allergy. 2003;58(7):572-9.
Pawankar R, Canonica GW, Holgate ST, Lockey RF, Blaiss MS. WAO white book on allergy. Milwaukee: World Allergy Organization; 2013.
Akhil H, Celik F, Ulas F, Kara IS. Dry eye syndrome and allergic conjunctivitis in the pediatric population. Midd East Afr J Ophthalmol 2015;22(4):467-1.
Doğan, Ü, Ağca S. Investigation of possible risk factors in the development of seasonal allergic conjunctivitis. Int J Ophthalmol. 2018;11(9):508-13.
Abelson MB, Shetty S, Korchak M, Butrus SI, Smith LM. Advances in pharmacotherapy for allergic conjunctivitis. Expert Opin Pharmacother. 2015;16(8):1219-31.
Chakraborti C, Mallik S, Choudhury KP, Das J. Childhood ocular morbidity in Eastern India: a tertiary hospital study. Sudanese J Public Health. 2012;7(4):126-30.
Kamath PBT, Prasad BS, Deepthi R, Muninrayana C. Prevalence of ocular morbidity among schoolgoing children (6-15years) in rural area of Karnataka, South India. Int J Pharm Biomed Res. 2012;3(4):209-12.
Mishra GP, Tamboli V, Jwala J and Mitra AK. Recent patents and emerging therapeutics in the treatment of allergic conjunctivitis. Recent Pat Inflamm Allergy Drug Discov. 2011;5(1):26-36.
Kanski J. Clinical ophthalmology. 4th ed. Windsor: Butterworth-Heinemann; 1999: 66-78.
Swamy BN, Chilov M, McClellan K, Petsoglou C. Topical non-steroidal anti-inflammatory drugs in allergic conjunctivitis: meta-analysis of randomized trial data. Ophthalmic Epidemiol. 2007;14(5):311-9.
Bielory L, Frohman L. Allergic and immunologic disorders of the eye. J Allergy Clin Immunol. 1992;86:1-20.
Keklikci U, Dursun B, Cingu AK. Topical cyclosporine a 0.05% eyedrops in treatment of vernal keratoconjunctivitis-randomized placebo-controlled trial. Adv Clin Exp Med. 2014;23(3):455-61.
Allansmith MR, Baird RS, Greiner JV. Vernal conjunctivitis and contact lens-associated giant papillary conjunctivitis compared and contrasted. Am J Ophthalmol. 1979;87(4):544-55.
Buckley RJ. Long-term experience with sodium cromoglycate in the management of vernal keratoconjunctivitis. In: Pepys J, Edward AM, eds. The mast cell, London: Pitman Medical; 1980.
Ukponmwan CU. Vernal conjunctivitis in Nigerians: 109 consecutive cases. Trop Doct. 2003;33(4):242-5.
Katelaris CH. Ocular allergy in the Asia Pacific region. Asia Pac Allergy. 2011;1(3):108-14.
Kumar S. Vernal keratoconjunctivitis: a major review. Acta Ophthalmol. 2009;87(2):133-47.
Bremond-Gignac D, Donadieu J, Leonardi A, Pouliquen P, Doan S, Chiambarretta F, et al. Prevalence of vernal keratoconjunctivitis: a rare disease? Br J Ophthalmol. 2008;92(2):1097-102.
Bonini S, Bonini S, Lambiase A, Marchi S, Pasqualetti P, Zuccaro O, et al. Vernal keratoconjunctivitis revisited: A case series of 195 patients with long-term followup. Ophthalmology 2000;107(6):1157-63.
Buckley RJ. Vernal keratoconjunctivitis. Int Ophthalmol Clin. 1988;28(4): 303-8.
Saboo US, Jain M, Reddy JC, Sangwan VS. Demographic and clinical profile of vernal keratoconjunctivitis at a tertiary eye care center in India. Ind J Ophthalmol. 2013;61(9):486-9.
Akpek EK, Hasiripi H, Christen WG, Kalayci D. A randomized trial of low dose mitomycin C in treatment of severe vernal keratoconjunctivitis. Opthalmology. 2010;107:263-9.
Sacchetti M, Baiardini I, Lambiase A, Aronni S, Fassio O, Gramiccioni C, et al. Development and testing of the quality of life in children with vernal keratoconjunctivitis questionnaire. Am J Ophthalmol. 2007;144(4):557-63.
Kubaisi B, Samra KA, Syeda S, Schmidt A, Foster SC. Ocular Allergy: an updated review. J Allergy Immunol. 2017;1:2.
Ackerman S, Smith LM, Gomes PJ. Ocular itch associated with allergic conjunctivitis: latest evidence and clinical management. Ther Adv Chronic Dis. 2016;7(1):52-67.
Bilkhu PS, Wolffsohn JS, Naroo SA, Robertson L, Kennedy R. Effectiveness of nonpharmacologic treatments for acute seasonal allergic conjunctivitis. Ophthalmology. 2014;121(1):72-8.
Berger WE, Granet DB, Kabat AG. Diagnosis and management of allergic conjunctivitis in pediatric patients. Allergy Asthma Proc. 2017;38(1):16-27.
Riggioni VS, Riggioni VC, Ribó GP. Diagnosis and management of allergic conjunctivitis. Curr Treat Options Allergy. 2018;5:256-65.
Kallarackal GU, Ansari EA, Amos N, Martin JC, Lane C, Camilleri JP. A comparative study to assess the clinical use of Fluorescein Meniscus Time (FMT) with Tear Break up Time (TBUT) and Schirmer’s tests (ST) in the diagnosis of dry eyes. Eye (Lond). 2002;16(5):594-600.
Zaki SA. Adverse drug reaction and causality assessment scales. Lung India. 2011;28(2):152-3.
Singh S, Mote R, Shukla S, Mali A, Khatri K. A comparative, randomized, double blind, parallel group and non-crossover multicentric study with bepotastine besilate ophthalmic solution vs. olopatidine hydrochloride ophthalmic solution in subjects suffering from allergic conjunctivitis. Euro J Biomed Pharm Sci. 2017;4(6):671-80.
Craig F McCabe, Shannon E McCabe. Comparative efficacy of bepotastine besilate 1.5% ophthalmic solution versus olopatadine hydrochloride 0.2% ophthalmic solution evaluated by patient preference. Clinic Ophthalmol. 2012;6:1731-8.
Sharma N, Kedia J. A study on the use of topical bepotastine besilate ophthalmic solution (BBOS) 1.5% in the treatment of allergic conjunctivitis. Ind J Clin Exp Ophthalmol. 2019;5(3):310-3.
Malahat AR, Kodudula S, Gali VL. A prospective comparative study to evaluate the efficacy and safety of olopatadine eye drops and bepotastine eye drops in subjects of vernal kerato conjunctivitis. Int J Basic Clin Pharmacol. 2020;9(5):706-11.
