Azithromycin (ophthalmic) clinical studies: Difference between revisions

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==Clinical Studies==
==Clinical Studies==
In a randomized, vehicle-controlled, double-blind, multicenter clinical study in which patients were dosed twice daily for the first two days, then once daily on days 3, 4, and 5, AzaSite solution was superior to vehicle on days 6-7 in patients who had a confirmed clinical diagnosis of bacterial conjunctivitis. Clinical resolution was achieved in 63% (82/130) of patients treated with AzaSite versus 50% (74/149) of patients treated with vehicle. The p-value for the comparison was 0.03 and the 95% confidence interval around the 13% (63%-50%) difference was 2% to 25%. The microbiological success rate for the eradication of the baseline pathogens was approximately 88% compared to 66% of patients treated with vehicle (p<0.001, confidence interval around the 22% difference was 13% to 31%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  |title = AZASITE (AZITHROMYCIN) SOLUTION [INSPIRE PHARMACEUTICALS, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5dc0f75a-1e14-469f-af4f-c668a32f2328 |publisher =  | date =  | accessdate = }}</ref>
In a randomized, vehicle-controlled, double-blind, multicenter clinical study in which patients were dosed twice daily for the first two days, then once daily on days 3, 4, and 5, AzaSite solution was superior to vehicle on days 6-7 in patients who had a confirmed clinical diagnosis of bacterial conjunctivitis. Clinical resolution was achieved in 63% (82/130) of patients treated with AzaSite versus 50% (74/149) of patients treated with vehicle. The p-value for the comparison was 0.03 and the 95% confidence interval around the 13% (63%-50%) difference was 2% to 25%. The microbiological success rate for the eradication of the baseline pathogens was approximately 88% compared to 66% of patients treated with vehicle (p<0.001, confidence interval around the 22% difference was 13% to 31%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  |title = AZASITE (AZITHROMYCIN) SOLUTION [INSPIRE PHARMACEUTICALS, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5dc0f75a-1e14-469f-af4f-c668a32f2328 |publisher =  | date =  | accessdate = }}</ref>



Latest revision as of 21:50, 5 January 2014

Azithromycin (ophthalmic)
AZASITE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Clinical Studies

In a randomized, vehicle-controlled, double-blind, multicenter clinical study in which patients were dosed twice daily for the first two days, then once daily on days 3, 4, and 5, AzaSite solution was superior to vehicle on days 6-7 in patients who had a confirmed clinical diagnosis of bacterial conjunctivitis. Clinical resolution was achieved in 63% (82/130) of patients treated with AzaSite versus 50% (74/149) of patients treated with vehicle. The p-value for the comparison was 0.03 and the 95% confidence interval around the 13% (63%-50%) difference was 2% to 25%. The microbiological success rate for the eradication of the baseline pathogens was approximately 88% compared to 66% of patients treated with vehicle (p<0.001, confidence interval around the 22% difference was 13% to 31%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.[1]

References

  1. "AZASITE (AZITHROMYCIN) SOLUTION [INSPIRE PHARMACEUTICALS, INC.]".

Adapted from the FDA Package Insert.