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 |
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.
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
site
Click here to add this to my saved trials