An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

985 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.

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Detailed Description

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Conditions

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Bacterial Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Moxifloxacin

Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9

Group Type EXPERIMENTAL

Moxifloxacin ophthalmic solution, 0.5%

Intervention Type DRUG

Ofloxacin

Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9

Group Type ACTIVE_COMPARATOR

Ofloxacin ophthalmic solution, 0.3%

Intervention Type DRUG

Interventions

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Moxifloxacin ophthalmic solution, 0.5%

Intervention Type DRUG

Ofloxacin ophthalmic solution, 0.3%

Intervention Type DRUG

Other Intervention Names

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VIGAMOX® Tarivid® Eye Drops

Eligibility Criteria

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Inclusion Criteria

* Chinese.
* Diagnosis of bacterial conjunctivitis based on clinical observation.
* Understand and sign the approved informed consent. Legally authorized representative can provide informed consent for patients less than 18 years old and/or incapable of understanding the informed consent.
* Willing to complete all required study procedures and visits.

Exclusion Criteria

* Women who are pregnant, lactating, or planning a pregnancy.
* Only 1 sighted eye or vision not correctable to 0.6 logMAR or better in either eye.
* Planned contact lens wear during the course of the study.
* Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1).
* Suspected fungal, viral, or Acanthamoeba infection.
* Any systemic or ocular disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study.
* History of recent surgery.
* Presence of concomitant systemic viral infection.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No