- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573910
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
April 27, 2015 updated by: Alcon Research
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
985
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Alcon (China) Ophthalmic Product Co., Ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moxifloxacin
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
|
Other Names:
|
Active Comparator: Ofloxacin
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
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Cure Rate
Time Frame: Day 9
|
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
|
Microbiological Success Rate
Time Frame: Day 9
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Helen Yu, Lead CSM, Alcon Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
April 6, 2012
First Submitted That Met QC Criteria
April 9, 2012
First Posted (Estimate)
April 10, 2012
Study Record Updates
Last Update Posted (Estimate)
May 12, 2015
Last Update Submitted That Met QC Criteria
April 27, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Eye Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Conjunctival Diseases
- Eye Infections, Bacterial
- Eye Infections
- Conjunctivitis
- Conjunctivitis, Bacterial
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Infective Agents, Urinary
- Renal Agents
- Moxifloxacin
- Ophthalmic Solutions
- Pharmaceutical Solutions
- Ofloxacin
Other Study ID Numbers
- C-10-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bacterial Conjunctivitis
-
Laboratoires TheaCompletedPurulent Bacterial ConjunctivitisFrance
-
IVIEW Therapeutics Inc.CompletedAcute Bacterial ConjunctivitisChina
-
Bausch & Lomb IncorporatedCompletedAcute Bacterial Conjunctivitis
-
Bausch & Lomb IncorporatedCompletedAcute Bacterial Conjunctivitis
-
Azidus BrasilUnknownAcute Bacterial ConjunctivitisBrazil
-
ShireCompletedBacterial ConjunctivitisUnited States, Australia, Austria, Israel, Poland, Hungary, South Africa, Canada, Estonia, France, Italy, Spain, Puerto Rico
-
AllerganCompletedBacterial ConjunctivitisUnited States, India
-
Beijing Tongren HospitalZhuhai Essex Bio-Pharmaceutical Company Limited; Panacea TechnologiesUnknownBacterial ConjunctivitisChina
-
Merck Sharp & Dohme LLCCompletedBacterial ConjunctivitisUnited States
-
Alcon ResearchWithdrawn
Clinical Trials on Moxifloxacin ophthalmic solution, 0.5%
-
Cornea Consultants Of NashvilleBausch & Lomb Incorporated; SCRI Development Innovations, LLCTerminatedCorneal UlcersUnited States
-
Aldeyra Therapeutics, Inc.CompletedDry Eye SyndromesUnited States
-
Aerie PharmaceuticalsCompletedOcular Hypertension | Open Angle GlaucomaUnited States
-
Meir Medical CenterUnknownPrimary PterygiumIsrael
-
Ophthalmic Consultants of BostonAllerganUnknownInfection | Eye InfectionUnited States
-
Aldeyra Therapeutics, Inc.Completed
-
Aldeyra Therapeutics, Inc.CompletedAllergic ConjunctivitisUnited States
-
Aldeyra Therapeutics, Inc.CompletedAllergic ConjunctivitisUnited States
-
Rigel PharmaceuticalsCompletedChronic Graft-versus-host DiseaseUnited States
-
Rigel PharmaceuticalsCompletedKeratoconjunctivitis SiccaUnited States