A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00347932
First received: June 30, 2006
Last updated: December 7, 2011
Last verified: December 2011
Results First Received: June 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Acute Bacterial Conjunctivitis
Interventions: Drug: ISV-403
Drug: Vehicle

  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
First subject enrolled 6/5/2006, last patient exited on 11/7/2007. This study was conducted at multiple sites in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
957 Subjects with bacterial conjunctivitis were randomized to receive besifloxacin ophthalmic suspension or its vehicle, 11 subjects were discontinued due to failure to meet enrollment criteria or used disallowed medications.

Reporting Groups
  Description
ISV-403 Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Vehicle Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.

Participant Flow:   Overall Study
    ISV-403     Vehicle  
STARTED     475 [1]   482 [1]
COMPLETED     444     430  
NOT COMPLETED     31     52  
Adverse Event                 4                 5  
Lack of Efficacy                 3                 14  
Lost to Follow-up                 10                 9  
Withdrawal by Subject                 10                 16  
Did not meet inclusion criteria                 4                 8  
[1] As Randomized population - received at least one dose of study medication



  Baseline Characteristics
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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.
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Reporting Groups
  Description
ISV-403 Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Vehicle Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Total Total of all reporting groups

Baseline Measures
    ISV-403     Vehicle     Total  
Number of Participants  
[units: participants]
  475     482     957  
Age, Customized  
[units: participants]
     
<2 years     21     20     41  
2 to 19 years     196     196     392  
20 to 59 years     212     226     438  
>=60 years     46     40     86  
Gender  
[units: participants]
     
Female     302     300     602  
Male     173     182     355  
Race/Ethnicity, Customized  
[units: Participants]
     
Caucasian     312     312     624  
Asian     10     7     17  
Black or African American     44     46     90  
Other     109     117     226  
Region of Enrollment  
[units: participants]
     
United States     475     482     957  



  Outcome Measures
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1.  Primary:   Clinical Resolution of Baseline Bacterial Conjunctivitis   [ Time Frame: Day 5 +/- 1 day ]

2.  Primary:   Microbial Eradication of Baseline Bacterial Infection   [ Time Frame: Day 5 +/- 1 day ]

3.  Secondary:   Clinical Resolution of Baseline Bacterial Conjunctivitis   [ Time Frame: Day 8 or 9 ]

4.  Secondary:   Microbial Eradication of Baseline Bacterial Infection   [ Time Frame: Day 8 or 9 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
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: Timothy Comstock
Organization: Bausch & Lomb Incorporated
phone: (585) 338-6631
e-mail: timothy.comstock@bausch.com


No publications provided by Bausch & Lomb Incorporated

Publications automatically indexed to this study:

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00347932     History of Changes
Other Study ID Numbers: 433, BOL-303224
Study First Received: June 30, 2006
Results First Received: June 29, 2009
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration