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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00564447
Recruitment Status : Completed
First Posted : November 28, 2007
Results First Posted : July 26, 2011
Last Update Posted : September 22, 2011
Sponsor:
Information provided by:
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Bacterial Infections
Eye Infections
Interventions Drug: Azithromycin
Drug: Moxifloxacin
Enrollment 48
Recruitment Details December 2007
Pre-assignment Details Normal volunteers
Arm/Group Title 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
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
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
Arm/Group Title 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
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 6 6 48
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
Female
5
  83.3%
2
  33.3%
2
  33.3%
3
  50.0%
1
  16.7%
5
  83.3%
2
  33.3%
3
  50.0%
23
  47.9%
Male
1
  16.7%
4
  66.7%
4
  66.7%
3
  50.0%
5
  83.3%
1
  16.7%
4
  66.7%
3
  50.0%
25
  52.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
6 6 6 6 6 6 6 6 48
1.Primary Outcome
Title Assessment of Pharmacokinetic Parameters
Hide Description [Not Specified]
Time Frame Up to 24 hours
Outcome Measure Data Not Reported
2.Primary Outcome
Title Assessment of Pharmacokinetic Parameters
Hide Description Conjunctiva Concentration of Azithromycin and Moxifloxacin
Time Frame Over 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: μg/g
130.8  (89.1) 51.6  (26.0) 67.1  (51.8) 31.9  (20.4) 1.9  (2.0) 3.8  (9.0) 0.0  (0.0) 0.0  (0.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 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
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      1/6 (16.67%)      1/6 (16.67%)      0/6 (0.00%)      3/6 (50.00%)      2/6 (33.33%)      0/6 (0.00%)      1/6 (16.67%)    
Eye disorders                 
Eye Pain † 2  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Eyelid Margin Crusting † 2  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders                 
Conjunctival Haemorrhage † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedRA 10.1
2
Term from vocabulary, MedDRA (10.1)
[Not Specified]
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research
Organization: Inspire Pharmaceuticals, Inc.
Phone: 010-941-9777
EMail: kkuhn@inspirepharm.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Saiid Davari, Inspire Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00564447    
Other Study ID Numbers: 041-102
P08654
First Submitted: November 20, 2007
First Posted: November 28, 2007
Results First Submitted: June 27, 2011
Results First Posted: July 26, 2011
Last Update Posted: September 22, 2011