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Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

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ClinicalTrials.gov Identifier: NCT00972777
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
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 Bacterial Conjunctivitis
Interventions Drug: Besifloxacin
Drug: Vehicle (Placebo)
Enrollment 474
Recruitment Details This was a two phase (IIB/III) integrated study. Phase IIb was conducted at 31 sites and Phase III at 28 sites in the United States. The first participant was enrolled in phase IIb on 10/30/2009, and last participant exited the study on 04/09/2010. Phase III enrolled its first participant on 04/05/2010 and last participant exited on 10/13/2010.
Pre-assignment Details A total of 474 participants were enrolled in the integrated study in the intent to treat(ITT) population. 276 participants had culture confirmed bacterial conjunctivitis and were assigned to the modified intent to treat(mITT) population. 464 participants were assigned to the safety population. 446 participants completed the study.
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description 0.6% ophthalmic suspension Vehicle of besifloxacin ophthalmic suspension
Period Title: Overall Study
Started 231 243
Completed 217 229
Not Completed 14 14
Reason Not Completed
Adverse Event             3             2
Lost to Follow-up             0             4
Withdrawal by Subject             4             5
Physician Decision             4             0
Protocol Violation             0             2
Screening Failure             2             1
Missed visit             1             0
Arm/Group Title Besifloxacin Vehicle Total
Hide Arm/Group Description 0.6% ophthalmic suspension Vehicle of besifloxacin ophthalmic suspension Total of all reporting groups
Overall Number of Baseline Participants 231 243 474
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 231 participants 243 participants 474 participants
<2 years 14 13 27
2 - 11 years 66 77 143
12 - 17 years 19 20 39
18 - 29 years 32 40 72
30 - 39 years 21 29 50
40 - 49 years 23 14 37
50 - 59 years 20 19 39
>=60 years 35 31 66
Missing 1 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 243 participants 474 participants
Female
142
  61.5%
133
  54.7%
275
  58.0%
Male
89
  38.5%
110
  45.3%
199
  42.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 231 participants 243 participants 474 participants
American Indian or Alaska Native 7 5 12
Asian 7 7 14
Native Hawaiian or Other Pacific Islander 0 2 2
Black or African American 45 58 103
White 167 166 333
Other 4 5 9
Missing 1 0 1
1.Primary Outcome
Title Clinical Resolution
Hide Description The absence of both conjunctival discharge and bulbar conjunctival injection.
Time Frame Visit 2
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical Resolution at Visit 2, (LOCF), mITT Population.
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:
0.6% ophthalmic suspension
Vehicle of besifloxacin ophthalmic suspension
Overall Number of Participants Analyzed 135 141
Measure Type: Number
Unit of Measure: eyes
89 62
2.Primary Outcome
Title Microbial Eradication
Hide Description The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time Frame Visit 2
Hide Outcome Measure Data
Hide Analysis Population Description
Microbial Eradication at Visit 2, (LOCF), mITT Population.
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:
0.6% ophthalmic suspension
Vehicle of besifloxacin ophthalmic suspension
Overall Number of Participants Analyzed 135 141
Measure Type: Number
Unit of Measure: eyes
115 77
3.Secondary Outcome
Title Clinical Resolution
Hide Description The absence of both conjunctival discharge and bulbar conjunctival injection.
Time Frame Visit 3
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical Resolution at Visit 3, (LOCF) mITT Population.
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:
0.6% ophthalmic suspension
Vehicle of besifloxacin ophthalmic suspension
Overall Number of Participants Analyzed 135 141
Measure Type: Number
Unit of Measure: eyes
103 94
4.Secondary Outcome
Title Microbial Eradication
Hide Description The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time Frame Visit 3
Hide Outcome Measure Data
Hide Analysis Population Description
Microbial Eradication at Visit 3, (LOCF), mITT Population.
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:
0.6% ophthalmic suspension
Vehicle of besifloxacin ophthalmic suspension
Overall Number of Participants Analyzed 135 141
Measure Type: Number
Unit of Measure: eyes
115 91
Time Frame 7 days
Adverse Event Reporting Description Safety Population, participants receiving at least one drop of study medication.
 
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description 0.6% ophthalmic suspension Vehicle of besifloxacin ophthalmic suspension
All-Cause Mortality
Besifloxacin Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Besifloxacin Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/228 (0.00%)   0/236 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Besifloxacin Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/228 (0.00%)   0/236 (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.
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tuyen Ong, MD, MRCOphth
Organization: Bausch & Lomb Incorporated
Phone: (973) 360-6389
EMail: tuyen.ong@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00972777     History of Changes
Other Study ID Numbers: 603
First Submitted: September 4, 2009
First Posted: September 9, 2009
Results First Submitted: January 12, 2012
Results First Posted: March 29, 2012
Last Update Posted: March 29, 2012