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

NCT02432807 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2024-10-23

Study results available
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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.

Conditions

  • Bacterial Conjunctivitis

Interventions

DRUG

Vancomycin 1.1%

Vancomycin hydrochloride ophthalmic ointment 1.1%

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Kurobe LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02432807 on ClinicalTrials.gov