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Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

This study has been completed.
Information provided by:
Alcon Research Identifier:
First received: September 23, 2008
Last updated: February 23, 2011
Last verified: February 2011
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 (Participant, Care Provider, 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) ]
    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) ]
    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


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

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 identifier: NCT00759148

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Terri Pasquine, Alcon 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

Keywords provided by Alcon Research:
pink eye

Additional relevant MeSH terms:
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Pharmaceutical Solutions
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
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
Nucleic Acid Synthesis Inhibitors processed this record on July 27, 2017