Bacterial Conjunctivitis Clinical Trial
Official title:
A Randomized, Multicenter, Double-Masked, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Vancomycin Hydrochloride Ophthalmic Ointment 1.1% in Patients With Moderate to Severe Bacterial Conjunctivitis
This is a Phase 3 study to evaluate the safety and efficacy of a vancomycin hydrochloride ophthalmic ointment dosed 4 times daily for 7 days compared to placebo (vehicle) in patients with moderate to severed Gram-positive bacterial conjunctivitis.
Bacterial conjunctivitis is common ocular disease caused by various types of bacteria
including methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant
Staphylococcus epidermidis (MRSE). External ocular infections such as those caused by MRSA or
MRSE frequently are not serious but in rare cases may be severe enough to threaten vision.
When ocular infections due to resistant organisms such as MRSA/MRSE do not respond to empiric
treatment with approved antibiotics, there are few treatment options. Vancomycin is one of
the few treatment options that has been shown to be effective against all clinical isolates
of MRSA/MRSE.
This study is a Phase 3 study to evaluate the safety and efficacy of a vancomycin
hydrochloride ophthalmic ointment in patients with moderate to severed Gram-positive
bacterial conjunctivitis including those with MRSA and MRSE. Subjects, who are adenovirus
negative, will be dosed with vancomycin hydrochloride ophthalmic ointment or placebo
(vehicle) 4 times daily for 7 days and evaluated for clinical and bacterial resolution of
their infection along with an assessment of the safety of the investigational product.
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