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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01573910
First received: April 6, 2012
Last updated: April 27, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Bacterial Conjunctivitis
Drug: Moxifloxacin ophthalmic solution, 0.5%
Drug: Ofloxacin ophthalmic solution, 0.3%
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Clinical Cure Rate [ Time Frame: Day 9 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 9 ] [ Designated as safety issue: No ]
    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.


Enrollment: 985
Study Start Date: May 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Moxifloxacin ophthalmic solution, 0.5%
Other Name: VIGAMOX®
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
Drug: Ofloxacin ophthalmic solution, 0.3%
Other Name: Tarivid® Eye Drops

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573910

Locations
China
Alcon (China) Ophthalmic Product Co., Ltd.
Beijing, China
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Helen Yu, Lead CSM Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01573910     History of Changes
Other Study ID Numbers: C-10-051
Study First Received: April 6, 2012
Results First Received: April 27, 2015
Last Updated: April 27, 2015
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Keywords provided by Alcon Research:
Bacterial conjunctivitis
Anti-infective
Antibiotics

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Bacterial Infections
Conjunctival Diseases
Eye Diseases
Eye Infections
Eye Infections, Bacterial
Infection
Levofloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Ofloxacin
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Renal Agents
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on September 01, 2015