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NCT Number: 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

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.

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Key information

Conditions

Bacterial Conjunctivitis Bacterial Infections Bacterial Infections and Mycoses Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Eye Diseases Eye Infections Eye Infections, Bacterial Infections

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alcon (China) Ophthalmic Product Co., Ltd.

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxifloxacin ophthalmic solution, 0.5%

Drug

Other names: VIGAMOX®

Ofloxacin ophthalmic solution, 0.3%

Drug

Other names: Tarivid® Eye Drops

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2012
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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