Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00575380

First received: December 12, 2007

Last updated: September 20, 2011

Last verified: September 2011

History of Changes

Results First Received: June 9, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Conditions:	Bacterial Infections Eye Infections Cataract Extraction
Interventions:	Drug: AzaSite Eye Drops Drug: Vigamox Eye Drops

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Azasite	No text entered.
Vigamox	No text entered.

Participant Flow: Overall Study

	Azasite	Vigamox
STARTED	58	58
COMPLETED	57	55
NOT COMPLETED	1	3
Withdrawal by Subject	1	0
Adverse Event	0	1
Various	0	2

Baseline Characteristics

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Reporting Groups

	Description
Azasite	No text entered.
Vigamox	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Azasite	Vigamox	Total
Number of Participants [units: participants]	58	58	116
Age [units: years] Mean ± Standard Deviation	71.0 ± 7.57	66.3 ± 10.02	68.6 ± 9.15
Gender [units: participants]
Female	34	28	62
Male	24	30	54

Outcome Measures

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1. Primary:

Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) [ Time Frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 ]

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2. Secondary:

Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) [ Time Frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 ]

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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: PI cannot publish or discuss trial results until written communication is received from Inspire

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: Mike Schiewe
Organization: Inspire
phone: 919-941-9777
e-mail: mschiewe@inspirepharm.com

No publications provided by Merck

Publications automatically indexed to this study:

Stewart WC, Crean CS, Zink RC, Brubaker K, Haque RM, Hwang DG. Pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor during and after the approved dosing regimens. Am J Ophthalmol. 2010 Nov;150(5):744-751.e2. Epub 2010 Sep 1.

Responsible Party:	Mike Schiewe, Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00575380 History of Changes
Other Study ID Numbers:	041-103, P08655
Study First Received:	December 12, 2007
Results First Received:	June 9, 2009
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration

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