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Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00759148
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : March 22, 2011
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% Other: Moxifloxacin AF Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye

Arms and Interventions
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Arm Intervention/treatment
Experimental: Moxifloxacin AF
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
 Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Eye drops
Placebo Comparator: Vehicle
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
 Other: Moxifloxacin AF Vehicle
Inactive ingredients used as a placebo for masking purposes


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Cure at the Day 4 (EOT)/Exit Visit [ Time Frame: Day 4 ]
    Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.


Secondary Outcome Measures :
  1. Microbiological Success at the Day 4 (EOT)/Exit Visit [ Time Frame: Day 4 ]
    Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.


Eligibility Criteria
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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with bacterial conjunctivitis in 1 or both eyes;
  • Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
  • Agrees to comply with the visit schedule and other requirements of the study;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
  • Presence of concomitant viral infection;
  • Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
  • Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
  • Infants undergoing treatment for retinopathy of prematurity;
  • Contact lens wear during the course of the study;
  • Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
  • Use of medications, as specified in the protocol;
  • Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
  • Known or suspected allergy or hypersensitivity to fluoroquinolones;
  • Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
  • Other protocol-specified exclusion criteria may apply.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759148


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon Research, Ltd. Alcon Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00759148    
Other Study ID Numbers: C-07-40
First Posted: September 25, 2008    Key Record Dates
Results First Posted: March 22, 2011
Last Update Posted: January 2, 2018
Last Verified: December 2017
Keywords provided by Alcon Research:
pink eye
conjunctivitis
moxifloxacin
fluoroquinolone
Additional relevant MeSH terms:
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Conjunctivitis, Bacterial
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Eye Infections
Moxifloxacin
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Pharmaceutical Solutions
Anti-Bacterial Agents
 Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female