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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01573910
First received: April 6, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to demonstrate non-inferiority of 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
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

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 ]
    The investigator will rate the ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) in each eye of the patient. Bulbar conjunctival injection and conjunctival discharge/exudates will be rated on a 4-point scale ranging from 0 to 3, with 0 = normal/absent; 1 = mild; 2 = moderate, and 3 = severe. Clinical cure will be considered attained if the sum of the ocular signs of bacterial conjunctivitis is 0.

  • Microbiological Success Rate [ Time Frame: Day 9 ] [ Designated as safety issue: No ]
    Microbiological specimen(s) from the patient's affected eye(s) will be collected according to a protocol-defined process. Microbiological success will be considered attained if the pre-therapy pathogens are eradicated.


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
One drop three times per day (TID) in both eyes for seven days, with a test-of-cure (TOC) at Day 9.
Drug: Moxifloxacin Ophthalmic Solution, 0.5%
Topical ocular solution. One drop instilled into the conjunctival sac of both eyes three times daily for seven days.
Active Comparator: Ofloxacin
One drop three times per day (TID) in both eyes for seven days, with a test-of-cure (TOC) at Day 9.
Drug: Ofloxacin Ophthalmic Solution, 0.3%
Topical ocular solution. One drop instilled into the conjunctival sac of both eyes three times daily for seven days.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least one year of age (of either sex and of Chinese race).
  • Diagnosis of bacterial conjunctivitis based on clinical observation.

    • Rating ≥1 for bulbar conjunctival injection and ≥1 for conjunctival discharge/exudate in at least one eye (the same eye) and;
    • Matting in the affected eye(s).
  • Understand and sign the approved Informed Consent. Legally authorized representative can provide informed consent for patients under 18 years old and/or patients incapable of understanding the Informed Consent.
  • Willing to complete all required study procedures and visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant or lactating women, women who have a positive urine pregnancy test, or women who are planning a pregnancy.
  • Only one sighted eye or vision not correctable to 0.6 logMAR or better in either eye. Visual acuity measurement for children less than 5 years of age is to be conducted at the discretion of the investigator. If visual acuity is not measured, the child must be able to fix and follow.
  • Participation in any other investigational clinical study within the previous 30 days.
  • Planned contact lens wear during the course of the study.
  • Presence of signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1).
  • Suspected fungal, viral, or Acanthamoeba infection based on clinical observation.
  • Presence of active inflammation and/or active structural change in the cornea, iris, or anterior chamber at Screening.
  • Known or suspected allergy or hypersensitivity to any component of the study medications.
  • Use of any topical ocular medications at time of entry into the study or during study participation.
  • 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
United States, Texas
Contact Alcon for Trial Locations
Fort Worth, Texas, United States, 76134
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
Last Updated: June 3, 2014
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
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Ofloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014