Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

This study has been completed.

Study NCT00759148 Information provided by Alcon Research

First Received on September 23, 2008. Last Updated on February 23, 2011 History of Changes

Results First Received: February 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Bacterial Conjunctivitis
Interventions:	Drug: Moxifloxacin eye drops Drug: Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients participated from 10/2008 to 03/2010

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1179 patients with bacterial conjunctivitis were randomized to Moxifloxacin AF or Moxifloxacin AF vehicle

Reporting Groups

	Description
Moxifloxacin AF	Moxifloxacin AF Ophthalmic Solution
Moxifloxacin AF Vehicle	Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)

Participant Flow: Overall Study

	Moxifloxacin AF	Moxifloxacin AF Vehicle
STARTED	593	586
COMPLETED	579	554
NOT COMPLETED	14	32

Baseline Characteristics

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Reporting Groups

	Description
Moxifloxacin AF	Moxifloxacin AF Ophthalmic Solution
Moxifloxacin AF Vehicle	Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)

Baseline Measures

	Moxifloxacin AF	Moxifloxacin AF Vehicle	Total
Number of Participants [units: participants]	593	586	1179
Age [units: participants]
<=18 years	294	303	597
Between 18 and 65 years	257	230	487
>=65 years	42	53	95
Gender [units: participants]
Female	353	338	691
Male	240	248	488

Outcome Measures

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1. Primary:

Clinical Cure of Bacterial Conjunctivitis [ Time Frame: Day 4 (12-48 hours after Day 3 final dose) ]

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2. Secondary:

Eradication of Baseline Bacteria (Microbiological Success) [ Time Frame: Day 4 (12-48 hours after Day 3 final dose) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor reserves the right to review study related information prior to presentation or publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937;817.568.6725
e-mail: medinfo@alconlabs.com

No publications provided by Alcon Research

Publications automatically indexed to this study:

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