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

Alcon

Status and phase

Completed

Phase 3

Conditions

Bacterial Conjunctivitis

Treatments

Drug: Moxifloxacin ophthalmic solution, 0.5%

Drug: Ofloxacin ophthalmic solution, 0.3%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01573910

C-10-051

Details and patient eligibility

About

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.

Enrollment

985 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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.
Other protocol-defined inclusion criteria may apply.

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.
Other protocol-defined exclusion criteria may apply.