Back to resultsAn 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
Primary Purpose
Bacterial Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Moxifloxacin ophthalmic solution, 0.5%
Ofloxacin ophthalmic solution, 0.3%
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring Bacterial conjunctivitis, Anti-infective, Antibiotics
Eligibility 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.
Sites / Locations
- Alcon (China) Ophthalmic Product Co., Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Moxifloxacin
Ofloxacin
Arm Description
Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01573910
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
Keywords
Bacterial conjunctivitis, Anti-infective, Antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
985 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxifloxacin
Arm Type
Experimental
Arm Description
Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
Arm Title
Ofloxacin
Arm Type
Active Comparator
Arm Description
Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin ophthalmic solution, 0.5%
Other Intervention Name(s)
VIGAMOX®
Intervention Type
Drug
Intervention Name(s)
Ofloxacin ophthalmic solution, 0.3%
Other Intervention Name(s)
Tarivid® Eye Drops
Primary Outcome Measure Information:
Title
Clinical Cure Rate
Description
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.
Time Frame
Day 9
Title
Microbiological Success Rate
Description
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.
Time Frame
Day 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Yu, Lead CSM
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon (China) Ophthalmic Product Co., Ltd.
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
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
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