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Comparative evaluation of olopatadine ophthalmic solution ( 0.1 % ) versus ketorolac ophthalmic solution ( 0.5 % ) using the provocative antigen challenge model . OBJECTIVE This study was conducted to compare the efficacy and safety of olopatadine ophthalmic solution ( 0.1 % ) with ketorolac ophthalmic solution ( 0.5 % ) in a clinical model of acute allergic conjunctivitis . Olopatadine is a dual acting H1 histamine receptor antagonist and a mast cell stabilizer , shown to be effective in treating allergic conjunctivitis . Ketorolac is a non-steroidal anti-inflammatory drug approved in the United States for the relief of ocular itching associated with seasonal allergic conjunctivitis . METHODS The provocative antigen challenge model was used in this randomized , double-blind , single-center , crossover study . The allergen and concentration that consistently elicited a positive allergic reaction was used for challenge . After at least 14 days , subjects were randomized to receive either olopatadine in one eye and placebo in the contralateral eye , or ketorolac in one eye and placebo in the contralateral eye . Twenty-seven minutes after drug instillation subjects were challenged with allergen . At 3 , 10 , and 20 minutes following allergen challenge , subjects graded ocular itching and were assessed for hyperemia in conjunctival , ciliary , and episcleral vessel beds . Approximately 14 days later , subjects received the alternate treatment in one eye and placebo in the contralateral eye . They were again challenged with allergen and their responses were rated in the same manner . RESULTS Olopatadine significantly ( p < 0.0001 ) reduced both ocular itching and hyperemia in all three vessel beds compared to placebo at all time points tested following allergen challenge . Ketorolac did not significantly reduce itching and showed a trend of increased hyperemia compared to placebo . Olopatadine was significantly ( p < 0.001 ) more effective than ketorolac in reducing hyperemia and ocular itching at all time points and was also significantly ( p < 0.05 ) more comfortable than ketorolac as reported by subjects immediately following drug instillation . CONCLUSION The study demonstrated that olopatadine is effective and safe in preventing and treating ocular itching and hyperemia associated with acute allergic conjunctivitis and is more effective and more comfortable than ketorolac .
882
Intervention_Pharmacological
olopatadine ophthalmic solution
883
Intervention_Pharmacological
ketorolac ophthalmic solution
884
Intervention_Pharmacological
olopatadine ophthalmic solution
885
Intervention_Pharmacological
ketorolac ophthalmic solution
886
Intervention_Pharmacological
Olopatadine
887
Intervention_Pharmacological
Ketorolac
888
Intervention_Pharmacological
olopatadine
889
Intervention_Control
placebo
890
Intervention_Pharmacological
ketorolac
891
Intervention_Control
placebo
892
Intervention_Control
placebo
893
Intervention_Pharmacological
Olopatadine
894
Intervention_Control
placebo
895
Intervention_Pharmacological
Ketorolac
896
Intervention_Control
placebo
897
Intervention_Pharmacological
Olopatadine
898
Intervention_Pharmacological
ketorolac
899
Intervention_Pharmacological
ketorolac
900
Intervention_Pharmacological
olopatadine
901
Intervention_Pharmacological
ketorolac
902
Outcome_Other
efficacy and safety
903
Outcome_Physical
graded ocular itching
904
Outcome_Physical
hyperemia in conjunctival , ciliary , and episcleral vessel beds .
905
Outcome_Physical
ocular itching
906
Outcome_Physical
hyperemia
907
Outcome_Physical
itching
908
Outcome_Other
effective
909
Outcome_Physical
hyperemia
910
Outcome_Physical
ocular itching
911
Outcome_Other
comfortable
912
Outcome_Physical
ocular itching
913
Outcome_Physical
hyperemia
914
Participant_Condition
acute allergic conjunctivitis .
915
Participant_Condition
allergic conjunctivitis .