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

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: NCT00575380
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : September 16, 2009
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
Cataract Extraction
Interventions Drug: AzaSite Eye Drops
Drug: Vigamox Eye Drops
Enrollment 116
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azasite Vigamox
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 58 58
Completed 57 55
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             0             1
Various             0             2
Arm/Group Title Azasite Vigamox Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 58 58 116
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 58 participants 116 participants
71.0  (7.57) 66.3  (10.02) 68.6  (9.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
Female
34
  58.6%
28
  48.3%
62
  53.4%
Male
24
  41.4%
30
  51.7%
54
  46.6%
1.Primary Outcome
Title Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Hide Description Nominal time is scheduled time relative to administration of the first eye drop
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azasite Vigamox
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: ug/g
Timepoint 1 - 1 hr (AzaSite and Vigamox) 40.4  (19.7752) 5.747  (3.4775)
Timepoint 2 - 12 hrs (AzaSite)/8 hrs (Vigamox) 33.55  (11.81) 1.051  (.8099)
Timepoint 3 - 48 hrs (AzaSite and Vigamox) 559.733  (1011.658) 1.129  (1.1673)
Timepoint 4 - 49 hrs (AzaSite and Vigamox) 98.6  (4.535) 15.754  (15.4107)
Timepoint 5 -72 hrs (AzaSite)/56 hrs (Vigamox) 287.75  (433.4355) .862  (.6801)
Timepoint 6 - 144 hrs (AzaSite and Vigamox) 175.017  (88.9250) .305  (.0917)
Timepoint 7 - 145 hrs (AzaSite and Vigamox) 269.46  (316.2821) 5.432  (4.0756)
Timepoint 8 - 168 hrs (AzaSite and Vigamox) 261.125  (169.1224) .322  (.1792)
Timepoint 9 - 216 hrs (AzaSite and Vigamox) 273.9  (160.4984) .165  (.1974)
Timepoint 10 - 312 (AzaSite and Vigamox) 63.867  (51.1578) .011  (.0098)
2.Secondary Outcome
Title Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azasite Vigamox
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: ug/mL
Timepoint 1- 1 hr (AzaSite and Vigamox) .022  (.0297) .582  (.506)
Timepoint 2- 12 hrs (AzaSite)/ 8 hrs (Vigamox) .088  (.0084) .113  (.0729)
Timepoint 3 - 48 hrs (AzaSite and Vigamox) .047  (.0515) .079  (.0543)
Timepoint 4 - 49 hrs (AzaSite and Vigamox) .023  (.0183) .765  (.5657)
Timepoint 5 - 72 hrs (AzaSite)/ 56 hr (Vigamox) .02  (.0099) .084  (.0261)
Timepoint 6 - 144 hrs (AzaSite and Vigamox) .026  (.0175) .225  (.1456)
Timepoint 7 - 145 hrs (AzaSite and Vigamox) .052  (.0694) .669  (.402)
Timepoint 8 - 168 hrs (AzaSite and Vigamox) .035  (.0276) .059  (.0265)
Timepoint 9 - 216 hrs (AzaSite and Vigamox) .028  (.0353) .071  (.0845)
Timepoint 10 - 312 hrs (AzaSite and Vigamox) .011  (.0102) .017  (.0189)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azasite Vigamox
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Azasite Vigamox
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Azasite Vigamox
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/58 (0.00%)      0/58 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Azasite Vigamox
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/58 (5.17%)      2/58 (3.45%)    
Investigations     
Intraocular pressure increased 1  3/58 (5.17%)  3 2/58 (3.45%)  2
1
Term from vocabulary, MedDRA 11.0
[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.
PI cannot publish or discuss trial results until written communication is received from Inspire
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mike Schiewe
Organization: Inspire
Phone: 919-941-9777
EMail: mschiewe@inspirepharm.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mike Schiewe, Inspire Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00575380    
Other Study ID Numbers: 041-103
P08655
First Submitted: December 12, 2007
First Posted: December 18, 2007
Results First Submitted: June 9, 2009
Results First Posted: September 16, 2009
Last Update Posted: September 22, 2011