NCT02432807

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Kurobe LLC · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Bacterial Conjunctivitis

Interventions

Type	Name	Description
DRUG	Vancomycin 1.1%	Vancomycin hydrochloride ophthalmic ointment 1.1%
DRUG	Placebo	Placebo

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2015-05-04
• Last updated: 2024-10-23
• Results posted: 2024-10-23

Locations

16 sites across 1 country: United States