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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00564447
First received: November 20, 2007
Last updated: September 20, 2011
Last verified: September 2011
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.
Total Total of all reporting groups

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 ]

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


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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:
unchecked 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.
unchecked 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.


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 Sharp & Dohme Corp.

Publications automatically indexed to this study:

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