Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00759148
First received: September 23, 2008
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Bacterial Conjunctivitis
Drug: Moxifloxacin eye drops
Drug: Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Clinical Cure of Bacterial Conjunctivitis [ Time Frame: Day 4 (12-48 hours after Day 3 final dose) ] [ Designated as safety issue: No ]
    Absence of bulbar conjunctival injection and conjunctival discharge/exudate (clinical cure)


Secondary Outcome Measures:
  • Eradication of Baseline Bacteria (Microbiological Success) [ Time Frame: Day 4 (12-48 hours after Day 3 final dose) ] [ Designated as safety issue: No ]
    Microbiological success


Enrollment: 1179
Study Start Date: October 2008
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Moxifloxacin AF Ophthalmic Solution
Drug: Moxifloxacin eye drops
eyedrops; 1 drop in each eye, twice daily for 3 days
Placebo Comparator: 2
Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
Drug: Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
Eyedrops; 1 drop in each eye, twice daily for 3 days

  Eligibility

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

Inclusion Criteria:

  • Signs and symptoms of bacterial conjunctivitis in one or both eyes

Exclusion Criteria:

  • Under 1 month in age
  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: NCT00759148

Locations
United States, Texas
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided by Alcon Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Terri Pasquine, Alcon
ClinicalTrials.gov Identifier: NCT00759148     History of Changes
Other Study ID Numbers: C-07-40
Study First Received: September 23, 2008
Results First Received: February 23, 2011
Last Updated: February 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
pink eye
conjunctivitis
moxifloxacin
fluoroquinolone

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

ClinicalTrials.gov processed this record on October 19, 2014