Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

This study has been completed.

Study NCT00575367 Information provided by Merck

First Received on December 14, 2007. Last Updated on September 20, 2011 History of Changes

Results First Received: August 10, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Conditions:	Bacterial Infections Eye Infections
Interventions:	Drug: AzaSite (azithromycin ophthalmic solution) Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)

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	19	18
COMPLETED	19	18
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
AzaSite	No text entered.
Vigamox	No text entered.

Baseline Measures

	AzaSite	Vigamox	Total
Number of Participants [units: participants]	18	17	35
Age ^[1] [units: years] Mean ± Standard Deviation	33.9 ± 12.59	38.1 ± 13.29	36.0 ± 12.92
Gender [units: participants]
Female	13	7	20
Male	5	10	15

[1]	Baseline measures for two subjects were not included in this analysis due to missing data on too many data points. Although the total number of baseline participants was 37, the actual number included in the analysis was 35 subjects, 18 subjects in the Azasite group and 17 in the Vigamox group.

Outcome Measures

1. Primary:

Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. [ Time Frame: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours ]

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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 Pharmaceuticals, Inc.

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: Karen Kuhn/ Director
Organization: Inspire Pharmaceuticals, Inc.
phone: 919 941-9777
e-mail: kkuhn@inspirepharm.com

No publications provided

Responsible Party:	Karen Kuhn, Inspire Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00575367 History of Changes
Other Study ID Numbers:	041-101, P08653
Study First Received:	December 14, 2007
Results First Received:	August 10, 2009
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration