To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5% Loteprednol eye drops for the treatment of ocular inflammation and infection associated bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual administration of azithromycin 1.5% and 0.5% Loteprednol (separately).
Estimated to be admitted a total of approximately 60 patients showing blepharitis and / or keratitis and / or conjunctivitis: 30 patients will be assigned to the group of Azithromycin 1.5%/Loteprednol 0.5% Eye Drops (fixed combination) + placebo and 30 patients will be assigned to the group of Azithromycin 1.5% + 0.5% Loteprednol (separately)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
1 drop, AO, QID
1 drop, QID, AO
Department of Ophthalmology of Hospital São Paulo
São Paulo, São Paulo, Brazil
Clinical cure
Clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study (D8)
Time frame: Day 8
irradication of pathogens
Success obtained with microbiological irradication of pathogens present at baseline
Time frame: Day 8
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