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
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Conjunctivitis
Intervention: Moxifloxacin ophthalmic solution, 0.5% (Drug); Ofloxacin ophthalmic solution, 0.3% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s):
Helen Yu, Lead CSM, Study Director, Affiliation: Alcon Research
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical Cure RateMicrobiological Success Rate
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Alcon (China) Ophthalmic Product Co., Ltd., Beijing, China
Additional Information
Starting date: May 2012
Last updated: April 27, 2015
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