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 is currently recruiting participants.
Verified December 2013 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01573910
First received: April 6, 2012
Last updated: December 4, 2013
Last verified: December 2013
  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.


Estimated Enrollment: 1042
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573910

Contacts
Contact: Alcon Call Center 1-888-451-3937

Locations
United States, Texas
Contact Alcon for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
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: December 4, 2013
Health Authority: China: Food and Drug Administration
China: Ethics Committee

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

Additional relevant MeSH terms:
Eye Infections, Bacterial
Eye Infections
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Bacterial 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 April 17, 2014