Comparative study of the efficacy and safety of olopatadine eyedrops and sodium cromoglycate in clinical practice: a prospective study


  • Scandashree K. Department of Pharmacology, Father Muller Medical College, Mangalore, Karnataka, India
  • Meghana Patil Department of Pharmacology, Father Muller Medical College, Mangalore, Karnataka, India
  • Padmaja Udaykumar Department of Pharmacology, Father Muller Medical College, Mangalore, Karnataka, India



Olopatadine, Allergic conjunctivitis, Sodium cromoglycate


Background: Allergic eye diseases are the commonest causes of ocular morbidity worldwide. To choose the best therapy in allergic conjunctivitis, understanding of underlying mechanisms implicated in triggering the allergy is very important. Olopatadine with a wide spectrum has proven to be very effective in allergic conjunctivitis. The objective of the study was to compare the efficacy and safety of ophthalmic solutions of olopatadine 0.2% once daily, olopatadine 0.1% twice daily and sodium cromoglycate 2% four times daily in allergic conjunctivitis for 3 weeks.

Methods: This was a prospective, single centre study enrolling 304 patients with allergic conjunctivitis attending ophthalmology clinics. Subjects were assessed for ocular signs and symptoms at 3 visits-baseline, week 2, week 3. The change from baseline in the mean scores of itching and redness at 3 weeks was primary outcome variable.

Results: The reduction in signs and symptoms were statistically significant in all the three groups (p <0.001). Both the olopatadine receiving groups were better than sodium cromoglycate receiving group in reducing ocular signs and symptoms by pairwise comparison by wilcoxon signed rank test.

Conclusions: Olopatadine ophthalmic solution is better than sodium cromoglycate ophthalmic solution in reducing the ocular signs and symptoms in allergic conjunctivitis.


Biswas J, Saha I, Das D, Bandyopadhyay S, Ray B, Biswas G. Ocular morbidity among children at a tertiary eye care hospital in Kolkata, West Bengal. Indian J Public Health. 2012;56(4):293.

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 school going children (6-15years) in rural area of Karnataka, South India. Int J Pharm Biomed Res. 2012;3(4):209-12.

McGill JI, Holgate ST, Church MK, Anderson DF, Bacon A. Allergic eye disease mechanisms. Br J Ophthalmol. 1998;82(10):1203-14.

Leonardi A, De dominicis, Motterle L. Immunopathogenesis of ocular allergy: a schematic approach to different clinical entities. Curr Opin Allergy Clin Immunol. 2007;7(5):429-35.

Mishra GP, Tamboli V, Jwala J, Mitra AK. Recent patents and emerging therapeutics in the treatment of allergic conjunctivitis. Recent Pat Inflamm Allergy Drug Discov. 2011;5(1):26-36.

Rosa M, Lionetti E, Reibaldi M, Russo A, Longo A, Leonardi S, et al. Allergic conjunctivitis: a comprehensive review of the literature. Ital J Pediatr. 2013;39:18.

Uchio E. Treatment of allergic conjunctivitis with olopatadine hydrochloride eye drops. Clin Ophthalmol. 2008;2(3):525-31.

Sharif NA, Xu SX, Miller ST, Gamache DA, Yanni JM. Characterization of the ocular antiallergic and antihistaminic effects of olopatadine (AL-4943A), a novel drug for treating ocular allergic diseases. J Pharmacol Exp Ther. 1996;278(3):1252-61.

Sharif NA, Xu SX, Yanni JM. Olopatadine (AL-4943A): ligand binding and functional studies on a novel, long acting H1-selective histamine antagonist and anti-allergic agent for use in allergic conjunctivitis. J Ocul Pharmacol Ther. 1996;12(4):401-7.

Brockman HL, Momsen MM, Knudtson JR, Miller ST, Graff G, Yanni JM. Interactions of olopatadine and selected antihistamines with model and natural membranes. Ocul Immunol Inflamm. 2003;11(4):247-68.

Cook EB, Stahl JL, Barney NP, Graziano FM. Olopatadine inhibits TNFα release from human conjunctival mast cells. Annals of Allergy, Asthma and Immunology. 2000;84(5):504-8.

Yanni JM, Weimer LK, Sharif NA, Xu SX, Gamache DA, Spellman JM. Inhibition of histamine-induced human conjunctival epithelial cell responses by ocular allergy drugs. Arch Ophthalmol. 1999;117(5):643-7.

Yanni JM, Stephens DJ, Miller ST, Weimer LK, Graff G, Parnell D, et al. The in vitro and in vivo ocular pharmacology of olopatadine (AL-4943A), an effective anti-allergic/antihistaminic agent. J Ocul Pharmacol Ther. 1996;12(4):389-400.

Butrus S, Greiner JV, Discepola M, Fingold I. Comparison of the clinical efficacy and comfort of olopatadine hydrochloride 0.1% ophthalmic solution and nedocromil sodium 2% ophthalmic solution in the human conjunctival allergen challenge model. Clin Ther. 2000;22:1462-72.

Katelaris CH, Ciprandi G, Missotten L, Turner FD, Bertin D, Berdeaux G. International olopatadine study group. a comparison of the efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and cromolyn sodium 2% ophthalmic solution in seasonal allergic conjunctivitis. Clin Ther. 2002;24(10):1561-75.

Abelson MB, Gomes PJ. Olopatadine 0.2% ophthalmic solution: the first ophthalmic antiallergy agent with once-daily dosing. Expert Opin Drug Metab Toxicol. 2008;4(4):453-61.

Abelson MB, Spangler DL, Epstein AB, Mah FS, Crampton HJ. Efficacy of once-daily olopatadine 0.2% ophthalmic solution compared to twice-daily olopatadine 0.1% ophthalmic solution for the treatment of ocular itching induced by conjunctival allergen challenge. Curr Eye Res. 2007;32(12):1017-22.

Friedlaender MH. Epinastine in the management of ocular allergic disease. Int Ophthalmol Clin. 2006;46(4):85-6.

Avunduk AM, Tekelioglu Y, Turk A, Akyol N. Comparison of effects of ketotifen fumarate 0.025% and olopatadine HCI 0.1% ophthalmic solutions in seasonal allergic conjunctivitis: a 30-day, randomized, double-masked, artificial tear substitute-controlled trial. Clin Ther. 2005;27:1392-402.

Berdy GJ, Stoppel JO, Ebstein AB. Comparison of the clinical efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and loteprednol etabonate 0.2% ophthalmic suspension in the conjunctival allergen challenge model. Clin Ther. 2002;24:918-29.

Kamis U, Ozturk BT, Ozkagnici A, Gunduz K. Comparison of the efficacy of olopatadine hydrochloride 0.1% ophthalmic solution and artificial tears in seasonal allergic conjunctivitis. Acta Ophthalmol Scand. 2006;84:148-9.

Aguilar AJ. Comparative study of clinical efficacy and tolerance in seasonal allergic conjunctivitis management with 0.1% olopatadine hydrochloride versus 0.05% ketotifen fumarate. Acta Ophthalmol Scand. 2000;78:52-5.

Leonardi A, Zafirakis P. Efficacy and comfort of olopatadine versus ketotifen ophthalmic solutions: a double-masked, environmental study of patient preference. Curr Med Res Opin. 2004;20:1167-73.

Lainer B, Finegold I, D’Arienzo P, Granet D, Ebstein AB, Ledgerwood GL: Clinical efficacy of olopatadine versus epinastine ophthalmic solution in the conjunctival allergen challenge model. Curr Med Res Opin. 2004;20:1227-33.

Lippert U, Moller A, Welker P, Artuc M, Henz BM. Inhibition of cytokine secretion from human leukemic mast cells and basophils by H1 and H2 receptor antagonists. Exp Dermatol. 2000;9:118-24.

Leonardi A, Quintieri L. Olopatadine: a drug for allergic conjunctivitis targeting the mast cell. Expert Opin Pharmacother. 2010;11(6):969-81.

Guest JF, Clegg JP, Smith AF. Health economic impact of olopatadine compared to branded and generic sodium cromoglycate in the treatment of seasonal allergic conjunctivitis in the UK. Curr Med Res Opin. 2006;22(9):1777-85.




How to Cite

K., S., Patil, M., & Udaykumar, P. (2017). Comparative study of the efficacy and safety of olopatadine eyedrops and sodium cromoglycate in clinical practice: a prospective study. International Journal of Basic & Clinical Pharmacology, 5(5), 1764–1769.



Original Research Articles