The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
400
Fusidic acid 1%
Placebo ophthalmic solution
Clinical Cure
Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.
Time frame: Visit 2 (Day 4)
Microbial Eradication
Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.
Time frame: Visit 2 (Day 4)
Microbial Eradication
Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.
Time frame: Visit 3 (Day 8)
Clinical Cure
Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.
Time frame: Visit 3 (Day 8)
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