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

Bacterial Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573910
• Other study ID #: C-10-051
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2012
• Last updated: April 27, 2015
• Start date: May 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 985
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• Moxifloxacin ophthalmic solution, 0.5%

• Ofloxacin ophthalmic solution, 0.3%

Locations

Country	Name	City	State
China	Alcon (China) Ophthalmic Product Co., Ltd.	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure Rate	Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.	Day 9	No
Primary	Microbiological Success Rate	Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.	Day 9	No