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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:1 - Any
Updated:5/5/2014
Start Date:May 2012
End Date:July 2014
Contact:Alcon Call Center
Phone:1-888-451-3937

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


Inclusion Criteria:

- Be at least one year of age (of either sex and of Chinese race).

- Diagnosis of bacterial conjunctivitis based on clinical observation.

- Rating ≥1 for bulbar conjunctival injection and ≥1 for conjunctival
discharge/exudate in at least one eye (the same eye) and;

- Matting in the affected eye(s).

- Understand and sign the approved Informed Consent. Legally authorized representative
can provide informed consent for patients under 18 years old and/or patients
incapable of understanding the Informed Consent.

- Willing to complete all required study procedures and visits.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Pregnant or lactating women, women who have a positive urine pregnancy test, or women
who are planning a pregnancy.

- Only one sighted eye or vision not correctable to 0.6 logMAR or better in either eye.
Visual acuity measurement for children less than 5 years of age is to be conducted
at the discretion of the investigator. If visual acuity is not measured, the child
must be able to fix and follow.

- Participation in any other investigational clinical study within the previous 30
days.

- Planned contact lens wear during the course of the study.

- Presence of signs and symptoms of bacterial conjunctivitis for longer than 4 days
prior to Screening (Day 1).

- Suspected fungal, viral, or Acanthamoeba infection based on clinical observation.

- Presence of active inflammation and/or active structural change in the cornea, iris,
or anterior chamber at Screening.

- Known or suspected allergy or hypersensitivity to any component of the study
medications.

- Use of any topical ocular medications at time of entry into the study or during study
participation.

- Other protocol-defined exclusion criteria may apply.
We found this trial at
1
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Fort Worth, Texas 76134
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Fort Worth, TX
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