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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
303
Vancomycin hydrochloride ophthalmic ointment 1.1%
Placebo
Unnamed facility
Paramount, California, United States
Unnamed facility
Petaluma, California, United States
Unnamed facility
Rancho Cordova, California, United States
Number of Subjects With Clinical Resolution of Bacterial Conjunctivitis
Between-group difference in clinical resolution of bacterial conjunctivitis (defined as absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection) at Day 8
Time frame: 8 days
Number of Subjects That Display Microbial Eradication
Between-group difference in microbial eradication (absence of all Gram-positive bacterial species present at or above the pathological threshold at baseline) at Day 8
Time frame: 8 days
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Unnamed facility
Deerfield Beach, Florida, United States
Unnamed facility
Waterloo, Iowa, United States
Unnamed facility
Newton, Kansas, United States
Unnamed facility
Pittsburg, Kansas, United States
Unnamed facility
Shawnee Mission, Kansas, United States
Unnamed facility
Havre de Grace, Maryland, United States
Unnamed facility
St Louis, Missouri, United States
...and 6 more locations