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

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ClinicalTrials.gov Identifier: NCT00347932
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : August 13, 2009
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acute Bacterial Conjunctivitis
Interventions Drug: ISV-403
Drug: Vehicle
Enrollment 957
Recruitment Details 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 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.
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Period Title: Overall Study
Started 475 [1] 482 [1]
Completed 444 430
Not Completed 31 52
Reason Not Completed
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
Arm/Group Title ISV-403 Vehicle Total
Hide Arm/Group Description Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. Total of all reporting groups
Overall Number of Baseline Participants 475 482 957
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 475 participants 482 participants 957 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 475 participants 482 participants 957 participants
Female
302
  63.6%
300
  62.2%
602
  62.9%
Male
173
  36.4%
182
  37.8%
355
  37.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 475 participants 482 participants 957 participants
Caucasian 312 312 624
Asian 10 7 17
Black or African American 44 46 90
Other 109 117 226
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 475 participants 482 participants 957 participants
475 482 957
1.Primary Outcome
Title Clinical Resolution of Baseline Bacterial Conjunctivitis
Hide Description The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Time Frame Day 5 +/- 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population, culture confirmed, as randomized
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description:
Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Overall Number of Participants Analyzed 199 191
Measure Type: Number
Unit of Measure: Participants
90 63
2.Primary Outcome
Title Microbial Eradication of Baseline Bacterial Infection
Hide Description Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Time Frame Day 5 +/- 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to treat population, culture confirmed, as randomized.
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description:
Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Overall Number of Participants Analyzed 199 191
Measure Type: Number
Unit of Measure: Participants
182 114
3.Secondary Outcome
Title Clinical Resolution of Baseline Bacterial Conjunctivitis
Hide Description The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Time Frame Day 8 or 9
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population, culture confirmed, as randomized
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description:
Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Overall Number of Participants Analyzed 199 191
Measure Type: Number
Unit of Measure: Participants
168 132
4.Secondary Outcome
Title Microbial Eradication of Baseline Bacterial Infection
Hide Description Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Time Frame Day 8 or 9
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population, culture confirmed, as randomized.
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description:
Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Overall Number of Participants Analyzed 199 191
Measure Type: Number
Unit of Measure: Participants
176 137
Time Frame 8 days
Adverse Event Reporting Description Treatment emergent ocular adverse events occured in < 5% of the patients
 
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
All-Cause Mortality
ISV-403 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ISV-403 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/442 (0.23%)      1/432 (0.23%)    
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1  1/442 (0.23%)  1 1/432 (0.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ISV-403 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/741 (0.00%)      0/760 (0.00%)    
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.
Sponsor has 45 days to review materials and provide comments back to the investigator.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Timothy Comstock
Organization: Bausch & Lomb Incorporated
Phone: (585) 338-6631
EMail: timothy.comstock@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00347932     History of Changes
Other Study ID Numbers: 433
BOL-303224 ( Registry Identifier: CAS )
First Submitted: June 30, 2006
First Posted: July 4, 2006
Results First Submitted: June 29, 2009
Results First Posted: August 13, 2009
Last Update Posted: March 24, 2015