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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 Rate

Microbiological 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

Page last updated: August 23, 2015

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