The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
Resolution of clinical signs of blepharitis
Time frame: Day 28
Time to first clinical resolution
Time frame: Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from baseline for clinical signs of blepharitis
Time frame: Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from end of dosing for clinical signs of blepharitis
Time frame: Days 42, 56, 70, and 84
Response to the Blepharitis Symptoms Questionnaire (BSQ)
Time frame: Days 1, 7, 14, 21, 28, 42, 56, 70, and 84
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