The Clinical Efficacy And Safety And Tolerability Of Olopatadine In Accordance With Emedastine And Loteprednol Etabonate In The Treatment Of Seasonal Allergic Conjunctivitis: A Randomized Vehicle-Controlled Group Study

Objective: Allergic conjunctivitis(AC)is a variety of agents of the disease which affects the physical and mental health of children,while it has not been found short-term,effective and safe treatment.In addition to that the compliance of the children is poor,so it is very necessary to search for the safe,effective and temporary medication program.The study was to compare the clinical efficacy,safety and tolerability of olopatadine 0.1%,emedastine 0.05%,loteprednol etabonate 0.5%(LE)and vehicle in the treatment of seasonal allergic conjunctivitis(SAC)for children.Methods: This was a prospective,randomized,sigle-masked and vehicle-controlled study.After acquiring written informed consent from all parents/guardians,according to the uniform diagnostic criteria in 80 cases of 160 eyes aged 4 to 10 children with SAC in the Ophthalmology center of the the Second Hospital Affiliated to Dalian Medical University,using random number table method,subjects were randomized 1:1:1:1 to receive olopatadine 0.1% 12 h interval time one drop of ophthalmic solution in each eye,emedastine 0.05% 12 h interval time one drop of ophthalmic solution in each eye,LE 0.5%(Lotemax)6h interval time one drop of ophthalmic solution in each eye, whereas for the control group artificial tear(AT)0.5%(Refresh Plus)8 h interval time one drop of ophthalmic solution in each eye.Objects were observed before treatment and following up observations were on 8th day and 15 th day after treatment.The primary measurement of efficacy and tolerability were focused on the signs(papilla,follicle,redness and edema)and symptoms(itching,photophobia and blinking)of subject-evaluated before and after treatment,in addition to the discomfort,the adverse events(AEs),visual acuity(VA),fundus and intraocular pressure(IOP).Results: After 1 week,emedastine and LE compared with vehicle was statistically significant differences(P < 0.05)in photophobia and redness;there were statistically significant differences(P < 0.05)among the 3 ophthalmic solutions comparing with the vehicle in papilla;LE compared with vehicle was statistically significant difference(P=0.023)in follicle.After 2 weeks,there were no statistically significant differences(P?0.05)among the 3 ophthalmic solutions in the improvement of the main symptoms(except for the blinking)and signs.All of them(except for photophobia,blinking and redness)were statistically significant differences(P < 0.05)comparing with the vehicle;olopatadine 0.1%,LE 0.5% compared with emedastine 0.05% was statistically significant difference(P < 0.05)in photophobia;emedastine 0.05% compared with LE 0.5% was statistically significant differences(P< 0.05)in blinking and redness.There were no evident changes in VA and there were no clinically significant changes in fundus.In our study,after 1 week and after 2 weeks,olopatadine 0.1%,emedastine 0.05% and LE 0.5%,there were no statistically significant differences(P?0.05)among the 3 ophthalmic solutions in IOP as well as between the treatment groups and the vehicle.In addition,there were no clinical significant changes in IOP(?10mm Hg)and there were no AEs.Conclusions: The efficacy of olopatadine 0.1%,emedastine 0.05% and LE 0.5% among the 3 ophthalmic solutions was similar;as for the safety and tolerability,there were no differences among themselves.