Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

This study has been completed.

Study NCT00564447 Information provided by Merck

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

Results First Received: June 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Conditions:	Bacterial Infections Eye Infections
Interventions:	Drug: Azithromycin Drug: Moxifloxacin

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
December 2007

Pre-Assignment Details

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

Reporting Groups

	Description
Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose	No text entered.
Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose	No text entered.
Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose	No text entered.
Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose	No text entered.
Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose	No text entered.
Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose	No text entered.
Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose	No text entered.
Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose	No text entered.

Participant Flow: Overall Study

	Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose	Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose	Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose	Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose
STARTED	6	6	6	6	6	6	6	6
COMPLETED	6	6	6	6	6	6	6	6
NOT COMPLETED	0	0	0	0	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose	No text entered.
Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose	No text entered.
Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose	No text entered.
Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose	No text entered.
Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose	No text entered.
Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose	No text entered.
Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose	No text entered.
Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose	No text entered.

Baseline Measures

	Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose	Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose	Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose	Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose	Total
Number of Participants [units: participants]	6	6	6	6	6	6	6	6	48
Age [units: years] Mean ± Standard Deviation	44.5 ± 11.1	46.8 ± 13.1	38.2 ± 13.2	33.7 ± 16.8	43.0 ± 13.7	43.5 ± 13.2	33.3 ± 8.2	36.7 ± 11.7	40.0 ± 12.8
Gender [units: participants]
Female	5	2	2	3	1	5	2	3	23
Male	1	4	4	3	5	1	4	3	25
Region of Enrollment [units: participants]
United States	6	6	6	6	6	6	6	6	48

Outcome Measures

1. Primary:

Assessment of Pharmacokinetic Parameters [ Time Frame: Over 24 hours ]

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2. Primary:

Assessment of Pharmacokinetic Parameters [ Time Frame: Up to 24 hours ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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: No text entered.

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
No text entered.

Results Point of Contact:

Name/Title: Director of Clinical Research
Organization: Inspire Pharmaceuticals, Inc.
phone: 010-941-9777
e-mail: kkuhn@inspirepharm.com

No publications provided by Merck

Publications automatically indexed to this study:

Torkildsen G, O'Brien TP. Conjunctival tissue pharmacokinetic properties of topical azithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active-controlled trial in healthy adult volunteers. Clin Ther. 2008 Nov;30(11):2005-14.

Responsible Party:	Saiid Davari, Inspire Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00564447 History of Changes
Other Study ID Numbers:	041-102, P08654
Study First Received:	November 20, 2007
Results First Received:	June 27, 2011
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration