Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis - Full Text View

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00759148

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 III

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:

MedlinePlus related topics: Pinkeye

Drug Information available for: Tetrahydrozoline Moxifloxacin Moxifloxacin hydrochloride Tetrahydrozoline hydrochloride

U.S. FDA Resources

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

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):

Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. Epub 2011 Jun 14.

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
Tetrahydrozoline
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012