Loteprednol Etabonate Suspension 0.2% Administered QID Compared With Olopatadine Solution 0.1% Administered BID in the Treatment of Seasonal Allergic Conjunctivitis: A Multicenter, Randomized, Investigator-Masked, Parallel Group Study in Chinese Patients

Clinical Therapeutics

Volumn 34, Issue 6, 2012, Pages 1259-1272.e1

  Gong, Lan ^a   Sun, Xinghuai ^a   Qu, Jia ^b   Wang, Lili ^c   Zhang, Mingzhi ^d   Zhang, Hong ^e   Wang, Linnong ^f   Gu, Yangshun ^g   Elion Mboussa, Albert ^h   Roy, Lipika ⁱ   Zhu, Byron ⁱ  

^a EYE AND ENT HOSPITAL OF FUDAN UNIVERSITY   (China)

^b WENZHOU MEDICAL UNIVERSITY   (China)

^c NANJING GENERAL HOSPITAL OF NANJING MILITARY COMMAND   (China)

^d Shantou University Medical College   (China)

^e SECOND HOSPITAL OF TIANJIN MEDICAL UNIVERSITY   (China)

^f NANJING MEDICAL UNIVERSITY   (China)

^g ZHEJIANG UNIVERSITY   (China)

^h BAUSCH AND LOMB   (United States)

ⁱ Bausch + Lomb (S) PTe Ltd   (Singapore)

Author keywords

Allergic conjunctivitis; Antihistamines; Corticosteroids; Loteprednol etabonate; Mast cell stabilizers; Olopatadine

Indexed keywords

LOTEPREDNOL ETABONATE; OLOPATADINE;

ADULT; ARTICLE; BIOMICROSCOPY; BLURRED VISION; BULBAR CONJUNCTIVA INJECTION; CHINESE; CONJUNCTIVA; CONJUNCTIVA DISEASE; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DISEASE SEVERITY; DRUG EFFICACY; DRUG FORMULATION; DRUG INSTILLATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPIDEMIC HEMORRHAGIC CONJUNCTIVITIS; FEMALE; FIBULA FRACTURE; HUMAN; INSTILLATION SITE ABNORMAL; INSTILLATION SITE STINGING; INTRAOCULAR PRESSURE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NASAL SEPTUM DEVIATION; OCULAR PRURITUS; OCULOPLETHYSMOGRAPHY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SEASONAL ALLERGIC CONJUNCTIVITIS; SIDE EFFECT; SINUSITIS; SUSPENSION; SWOLLEN EYELID; TREATMENT DURATION; TREATMENT OUTCOME; VISUAL ACUITY;

EID: 84862129570     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2012.04.024     Document Type: Article

References (35)

1. Anderson D.F. Management of seasonal allergic conjunctivitis (SAC): current therapeutic strategies. Clin Exp Allergy 2001, 31:823-826.
2. Singh K., Axelrod S., Bielory L. The epidemiology of ocular and nasal allergy in the United States, 1988-1994. J Allergy Clin Immunol 2010, 126:778-783. e6.
3. Bielory L., Katelaris C.H., Lightman S., Naclerio R.M. Treating the ocular component of allergic rhinoconjunctivitis and related eye disorders. MedGenMed 2007, 9:35.
4. Bielory B.P., O'Brien T., Bielory L. Management of seasonal allergic conjunctivitis: guide to therapy. Acta Ophtahlmol 2011, Nov 8. [Epub ahead of print]. 10.1111/j.1755-3768.2011.02272.x.
5. Chambless S.L., Trocme S. Developments in ocular allergy. Curr Opin Allergy Clin Immunol 2004, 4:431-434.
6. Butrus S., Portela R. Ocular allergy: diagnosis and treatment. Ophthalmol Clin North Am 2005, 18:485-492. v.
7. Leonardi A. Emerging drugs for ocular allergy. Expert Opin Emerg Drugs 2005, 10:505-520.
8. Ilyas H., Slonim C.B., Braswell G.R., et al. Long-term safety of loteprednol etabonate 0.2% in the treatment of seasonal and perennial allergic conjunctivitis. Eye Contact Lens 2004, 30:10-13.
9. Kitamura Y., Miyoshi A., Murata Y., et al. Effect of glucocorticoid on upregulation of histamine H1 receptor mRNA in nasal mucosa of rats sensitized by exposure to toluene diisocyanate. Acta Otolaryngol 2004, 124:1053-1058.
10. Fukui H. Progress in allergy signal research on mast cells: up-regulation of histamine signal-related gene expression in allergy model rats. J Pharmacol Sci 2008, 106:325-331.
11. Ohmori K., Hasegawa K., Tamura T., et al. Properties of olopatadine hydrochloride, a new antiallergic/antihistaminic drug. Arzneimittelforschung 2004, 54:809-829.
12. Yanni J.M., Weimer L.K., Sharif N.A., et al. Inhibition of histamine-induced human conjunctival epithelial cell responses by ocular allergy drugs. Arch Ophthalmol 1999, 117:643-647.
13. Yanni J.M., Miller S.T., Gamache D.A., et al. Comparative effects of topical ocular anti-allergy drugs on human conjunctival mast cells. Ann Allergy Asthma Immunol 1997, 79:541-545.
14. Druzgala P., Wu W.M., Bodor N. Ocular absorption and distribution of loteprednol etabonate, a soft steroid, in rabbit eyes. Curr Eye Res 1991, 10:933-937.
15. Novack G.D., Howes J., Crockett R.S., Sherwood M.B. Change in intraocular pressure during long-term use of loteprednol etabonate. J Glaucoma 1998, 7:266-269.
16. Bartlett J.D., Horwitz B., Laibovitz R., Howes J.F. Intraocular pressure response to loteprednol etabonate in known steroid responders. J Ocul Pharmacol 1993, 9:157-165.
17. Manabe S., Bucala R., Cerami A. Nonenzymatic addition of glucocorticoids to lens proteins in steroid-induced cataracts. J Clin Invest 1984, 74:1803-1810.
18. Abelson M.B., Turner D. A randomized, double-blind, parallel-group comparison of olopatadine 0.1% ophthalmic solution versus placebo for controlling the signs and symptoms of seasonal allergic conjunctivitis and rhinoconjunctivitis. Clin Ther 2003, 25:931-947.
19. Katelaris C.H., Ciprandi G., Missotten L., et al. 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, 24:1561-1575.
20. Shulman D.G., Lothringer L.L., Rubin J.M., et al. A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis. Ophthalmology 1999, 106:362-369.
21. Dell S.J., Lowry G.M., Northcutt J.A., et al. A randomized, double-masked, placebo-controlled parallel study of 0.2% loteprednol etabonate in patients with seasonal allergic conjunctivitis. J Allergy Clin Immunol 1998, 102:251-255.
22. Uchio E. Treatment of allergic conjunctivitis with olopatadine hydrochloride eye drops. Clin Ophthalmol 2008, 2:525-531.
23. ICH harmonised tripartite guideline: guideline for good clinical practice E6(R1) International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Accessed March 20, 2012. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf.
24. Declaration of Helsinki: ethical principles for medical research involving human subjects World Medical Association, Accessed September 6, 2011. http://wma/net/en/policy/b3.htm.
25. Good clinical practice State Food and Drug Adminstration (China), Accessed March 20, 2012. http://www.sfda.gov.cn/WS01/CL0053/24473.html.
26. Dmitrienko A., Tamhance A. Analysis of multiple endpoints in clinical trials. Multiple Testing Problem in Pharmaceutical Statistics 2010, 138-139. Chapman and Hall/CRC Press, Boca Raton, FL. A. Dmitrienko, A. Tamhance, F. Bretz (Eds.).
27. Littell R., Milliken G., Stroup W., et al. Analysis of repeated measures data. SAS for Mixed Models 2008, 159-202. SAS Institute, Inc., Cary, NC. Second Edition.
28. Joss J., Craig T. Seasonal allergic conjunctivitis. Drugs Today (Barc) 1998, 34:259-265.
29. Stewart R., Horwitz B., Howes J., et al. Double-masked, placebo-controlled evaluation of loteprednol etabonate 0.5% for postoperative inflammation. Loteprednol Etabonate Post-operative Inflammation Study Group 1. J Cataract Refract Surg 1998, 24:1480-1489.
30. A double-masked, placebo-controlled evaluation of 0.5% loteprednol etabonate in the treatment of postoperative inflammation. Ophthalmology 1998, 105:1780-1786.
31. Comstock T.L., Paterno M.R., Singh A., et al. Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery. Clin Ophthalmol 2011, 5:177-186.
32. Friedlaender M.H., Howes J. A double-masked, placebo-controlled evaluation of the efficacy and safety of loteprednol etabonate in the treatment of giant papillary conjunctivitis. The Loteprednol Etabonate Giant Papillary Conjunctivitis Study Group I. Am J Ophthalmol 1997, 123:455-464.
33. Dell S.J., Shulman D.G., Lowry G.M., Howes J. A controlled evaluation of the efficacy and safety of loteprednol etabonate in the prophylactic treatment of seasonal allergic conjunctivitis. Loteprednol Allergic Conjunctivitis Study Group. Am J Ophthalmol 1997, 123:791-797.
34. Koo EH, Samudre S, Williams PB. Loteprednol etabonate ophthalmic suspension 0.2% (ALREX®) and olopatadine hydrochloride ophthalmic solution 0.1% (PATANOL®) in the treatment of allergic conjunctivitis. Presented at the Association for Research in Vision and Ophthalmology Annual Meeting, April 27-May 1, 2008, Fort Lauderdale, FL.
35. Berdy G.J., Stoppel J.O., Epstein A.B. 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, 24:918-929.