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document
A randomized , double-masked , placebo-controlled parallel study of loteprednol etabonate 0.2 % in patients with seasonal allergic conjunctivitis . OBJECTIVE To evaluate the effects of loteprednol etabonate ( LE ) 0.2 % in reducing the signs and symptoms of seasonal allergic conjunctivitis . DESIGN Randomized , double-masked , placebo-controlled , parallel group multicenter study of 6 weeks duration . PARTICIPANTS A total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated . INTERVENTION All patients received either LE 0.2 % or placebo ( vehicle ) four times a day in both eyes for 42 days . MAIN OUTCOME MEASURES Bulbar conjunctival injection ( primary sign ) and itching ( primary symptom ) over the first 2 weeks of treatment was measured . RESULTS A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection ( 1.5 vs. 1.0 units on a 0-3 scale ) and itching ( 3.4 vs. 3.0 units on a 0-4 scale ) over the first 2 weeks . The treatment effect by these measures was -0.5 and -0.4 units in favor of LE ( P < or = 0.008 ) . Resolution ( i.e. , the proportion of patients with signs or symptoms no longer present ) at day 14 strongly favored LE-treated patients ( 36 % and 15 % ; 58 % and 38 % , for injection and itching , respectively ) . Both treatments were well tolerated . One patient in each treatment group ( 1 of 67 and 1 of 68 , respectively ) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment . CONCLUSIONS Loteprednol etabonate 0.2 % was more effective than placebo in the treatment of seasonal allergic conjunctivitis . Loteprednol etabonate 0.2 % had a safety profile comparable to placebo .
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Intervention_Pharmacological
loteprednol etabonate
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Intervention_Pharmacological
loteprednol etabonate ( LE )
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
LE 0.2 %
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Intervention_Control
placebo
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Outcome_Physical
seasonal allergic conjunctivitis .
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Outcome_Physical
Bulbar conjunctival injection ( primary sign ) and itching ( primary symptom )
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Outcome_Physical
reduction in severity
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Outcome_Physical
bulbar conjunctival injection
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Outcome_Other
proportion of patients with signs or symptoms no longer present )
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Outcome_Other
tolerated
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Outcome_Physical
elevation of intraocular pressure
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Participant_Condition
seasonal allergic conjunctivitis
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Participant_Sample-size
135
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Participant_Condition
seasonal allergic conjunctivitis