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Trial record 68 of 76 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate"

A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

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ClinicalTrials.gov Identifier: NCT00348348
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: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acute Bacterial Conjunctivitis
Interventions Drug: Besifloxacin
Drug: Moxifloxacin solution
Enrollment 1161
Recruitment Details This study was conducted at 84 sites in the US and Asia. First subject was enrolled 6/6/06, and last subject visit was 7/13/07.
Pre-assignment Details 1161 participants were randomized of which 533 had culture confirmed bacterial conjunctivitis.
Arm/Group Title Moxifloxacin Solution Besifloxacin Suspension
Hide Arm/Group Description Moxifloxacin hydrochloride ophthalmic solution 0.5% Besifloxacin ophthalmic suspension 0.6%
Period Title: Overall Study
Started 579 [1] 582 [2]
Completed 554 555
Not Completed 25 27
Reason Not Completed
Adverse event - unrelated to study drug             0             1
Lack of Efficacy             1             1
Lost to Follow-up             8             10
Withdrawal by Subject             4             1
Not specified             7             4
Dissallowed Meds - unrelated to study             1             3
Dissallowed Meds - unlikley related             1             1
Dissallowed Meds - possibly releated             1             1
Worsening of BC - Unrelated to study             0             3
Worsening of BC - Unlikely related             1             2
Adverse event probably related to study             1             0
[1]
Received at least one drop of study medication (Safety Population)
[2]
Received at least one drop of study medication(Safety Population)
Arm/Group Title Moxifloxacin Solution Besifloxacin Suspension Total
Hide Arm/Group Description Moxifloxacin hydrochloride ophthalmic solution 0.5% Besifloxacin ophthalmic suspension 0.6% Total of all reporting groups
Overall Number of Baseline Participants 579 582 1161
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 579 participants 582 participants 1161 participants
<2 years 15 22 37
2 to 9 years 90 91 181
10 to 19 years 81 75 156
20 to 29 years 73 93 166
30 to 39 years 76 71 147
40 to 49 years 59 68 127
50 to 59 years 65 63 128
>/= 60 years 120 99 219
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 579 participants 582 participants 1161 participants
Female
323
  55.8%
332
  57.0%
655
  56.4%
Male
256
  44.2%
250
  43.0%
506
  43.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 579 participants 582 participants 1161 participants
American Indian or Alaskan Native 6 3 9
Asian 89 87 176
Black or African American 63 73 136
Native Hawaiian or Pacific Islander 2 5 7
White 391 385 776
Other 28 29 57
1.Primary Outcome
Title Clinical Resolution
Hide Description Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Time Frame Day 5(+/- 1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent to treat (mITT), culture confirmed, as treated
Arm/Group Title Moxifloxacin Solution Besifloxacin Suspension
Hide Arm/Group Description:
Moxifloxacin hydrochloride ophthalmic solution 0.5%
Besifloxacin ophthalmic suspension 0.6%
Overall Number of Participants Analyzed 281 252
Measure Type: Number
Unit of Measure: Participants
167 147
2.Primary Outcome
Title Microbial Eradication
Hide Description eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time Frame Day 5 (+/- 1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent to treat (mITT), culture confirmed, as treated
Arm/Group Title Moxifloxacin Solution Besifloxacin Suspension
Hide Arm/Group Description:
Moxifloxacin hydrochloride ophthalmic solution 0.5%
Besifloxacin ophthalmic suspension 0.6%
Overall Number of Participants Analyzed 281 252
Measure Type: Number
Unit of Measure: Participants
256 235
3.Secondary Outcome
Title Clinical Resolution
Hide Description Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated
Time Frame Day 8 or Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent to treat (mITT), culture confirmed, as treated
Arm/Group Title Moxifloxacin Solution Besifloxacin Suspension
Hide Arm/Group Description:
Moxifloxacin hydrochloride ophthalmic solution 0.5%
Besifloxacin ophthalmic suspension 0.6%
Overall Number of Participants Analyzed 281 252
Measure Type: Number
Unit of Measure: Participants
236 213
4.Secondary Outcome
Title Microbial Eradication
Hide Description Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time Frame Day 8 or Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent to treat (mITT), culture confirmed, as treated
Arm/Group Title Moxifloxacin Solution Besifloxacin Suspension
Hide Arm/Group Description:
Moxifloxacin hydrochloride ophthalmic solution 0.5%
Besifloxacin ophthalmic suspension 0.6%
Overall Number of Participants Analyzed 281 252
Measure Type: Number
Unit of Measure: Participants
238 220
Time Frame Participants were treated three times daily for 5 days
Adverse Event Reporting Description Safety population - All treated eyes
 
Arm/Group Title Moxifloxacin Solution Besifloxacin Suspension
Hide Arm/Group Description Moxifloxacin hydrochloride ophthalmic solution 0.5% Besifloxacin ophthalmic suspension 0.6%
All-Cause Mortality
Moxifloxacin Solution Besifloxacin Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Moxifloxacin Solution Besifloxacin Suspension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/579 (0.17%)      1/582 (0.17%)    
Cardiac disorders     
Congestive heart failure  1 [1]  1/579 (0.17%)  1 1/582 (0.17%)  1
Infections and infestations     
Acute viral syndrome  1 [2]  1/579 (0.17%)  1 1/582 (0.17%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Considered unrelated to therapy
[2]
Unlikely related to treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Moxifloxacin Solution Besifloxacin Suspension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/855 (0.00%)      0/865 (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
Name/Title: Timothy Comstock
Organization: Bausch & Lomb Incorporated
Phone: (585) 338-6631
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00348348     History of Changes
Other Study ID Numbers: 434
First Submitted: June 30, 2006
First Posted: July 4, 2006
Results First Submitted: June 30, 2009
Results First Posted: August 13, 2009
Last Update Posted: March 24, 2015