Last updated on July 2017

Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02432807

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Drey Coleman

Paramount, CA United States
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Drey Coleman

Petaluma, CA United States
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Drey Coleman

Rancho Cordova, CA United States
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Drey Coleman

Deerfield Beach, FL United States
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Drey Coleman

Waterloo, IA United States
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Drey Coleman

Newton, KS United States
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Drey Coleman

Pittsburg, KS United States
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Drey Coleman

Shawnee, KS United States
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Drey Coleman

Havre de Grace, MD United States
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Drey Coleman

Saint Louis, MO United States
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Drey Coleman

Asheville, NC United States
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Drey Coleman

High Point, NC United States
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Drey Coleman

Cincinnati, OH United States
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Drey Coleman

Roseburg, OR United States
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Drey Coleman

Spartanburg, SC United States
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Drey Coleman

Memphis, TN United States
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