Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

This study is currently recruiting participants.

Verified by Alcon Research, October 2008

First Received: September 23, 2008 Last Updated: October 22, 2008 History of Changes

Sponsored by:	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: Moxifloxicin AF Ophthalmic Solution Vehicle (placebo)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

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:

Resolution of bulbar conjunctival injection and conjunctival discharge/exudate at the Day 4/Exit Visit [ Time Frame: Day 1 and Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Eradication of pre-therapy pathogens at the Day 4/Exit Visit [ Time Frame: Day 1 and Day 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1644
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Moxifloxicin AF Ophthalmic Solution	Drug: Moxifloxacin eye drops eyedrops; 1 drop in each eye, twice daily for 3 days
2: Placebo Comparator Moxifloxicin AF Ophthalmic Solution Vehicle (placebo)	Drug: Moxifloxicin 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

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Contact Alcon Call Center for Study Locations	Recruiting
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon ( Terri Pasquine )
Study ID Numbers:	C-07-40
Study First Received:	September 23, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00759148 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

pink eye
conjunctivitis
moxifloxacin
fluoroquinolone

Study placed in the following topic categories:

Bacterial Infections
Anti-Infective Agents
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Fluoroquinolones
Moxifloxacin

Eye Diseases
Eye Infections
Tetrahydrozoline
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Moxifloxacin
Therapeutic Uses

Eye Diseases
Eye Infections
Conjunctivitis
Infection
Pharmacologic Actions
Conjunctival Diseases

ClinicalTrials.gov processed this record on September 11, 2009