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Trial record 9 of 26 for:    "Bacterial Conjunctivitis" | "Anti-Bacterial Agents"

Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis

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ClinicalTrials.gov Identifier: NCT01740388
Recruitment Status : Terminated (Strategic business decision)
First Posted : December 4, 2012
Results First Posted : September 17, 2014
Last Update Posted : October 1, 2014
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
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Period Title: Overall Study
Started 64 72
Completed 18 28
Not Completed 46 44
Reason Not Completed
Withdrawal by Subject             1             2
Lost to Follow-up             2             0
Physician Decision             2             6
Subjects missing data, completed             41             36
Arm/Group Title Besifloxacin Vehicle Total
Hide Arm/Group Description

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Total of all reporting groups
Overall Number of Baseline Participants 64 72 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 72 participants 136 participants
44.6  (22.52) 50.6  (21.36) 47.8  (22.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 72 participants 136 participants
Female
44
  68.8%
44
  61.1%
88
  64.7%
Male
20
  31.3%
28
  38.9%
48
  35.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 72 participants 136 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   6.3%
7
   9.7%
11
   8.1%
Native Hawaiian or Other Pacific Islander
1
   1.6%
1
   1.4%
2
   1.5%
Black or African American
4
   6.3%
7
   9.7%
11
   8.1%
White
51
  79.7%
56
  77.8%
107
  78.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   6.3%
1
   1.4%
5
   3.7%
1.Primary Outcome
Title Clinical Resolution
Hide Description Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time Frame Visit 2 (Day 4 or 5)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Overall Number of Participants Analyzed 18 28
Measure Type: Number
Unit of Measure: participants
YES 4 5
NO 14 23
2.Primary Outcome
Title Microbial Eradication
Hide Description Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time Frame Visit 2 (Day 4 or 5)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is only Subjects with non-missing data, Microbial Eradication (LOCF [Last Observation Carried Forward])
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Overall Number of Participants Analyzed 18 28
Measure Type: Number
Unit of Measure: participants
YES 17 13
NO 1 15
3.Secondary Outcome
Title Clinical Resolution
Hide Description Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time Frame Visit 3 (Day 6, 7, or 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Overall Number of Participants Analyzed 18 28
Measure Type: Number
Unit of Measure: participants
YES 6 13
NO 12 15
4.Secondary Outcome
Title Microbial Eradication
Hide Description Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time Frame Visit 3 (Day 6, 7, or 8)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Overall Number of Participants Analyzed 18 28
Measure Type: Number
Unit of Measure: participants
YES 14 16
NO 4 12
5.Other Pre-specified Outcome
Title Ocular Conjunctival Discharge
Hide Description Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe
Time Frame At each follow-up visit (Visit 1, Visit 2 and Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is only Subjects with non-missing data, Ocular Discharge Evaluated on the Baseline-Designated Study Eye
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Overall Number of Participants Analyzed 18 28
Measure Type: Number
Unit of Measure: participants
Visit 1: Absent 0 0
Visit 1: Mild 6 9
Visit 1: Moderate 10 16
Visit 1: Severe 2 3
Visit 2: Absent 9 10
Visit 2: Mild 8 15
Visit 2: Moderate 1 2
Visit 2: Severe 0 0
Visit 3: Absent 14 16
Visit 3: Mild 4 5
Visit 3: Moderate 0 3
Visit 3: Severe 0 0
6.Other Pre-specified Outcome
Title Bulbar Conjunctival Injection
Hide Description Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe
Time Frame At each follow-up visit (Visit 1, Visit 2 and Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Overall Number of Participants Analyzed 18 28
Measure Type: Number
Unit of Measure: participants
Visit 1: Normal 0 0
Visit 1: Mild 3 6
Visit 1: Moderate 14 18
Visit 1: Severe 1 4
Visit 2: Normal 4 7
Visit 2: Mild 13 12
Visit 2: Moderate 1 8
Visit 2: Severe 0 0
Visit 3: Normal 7 12
Visit 3: Mild 11 6
Visit 3: Moderate 0 5
Visit 3: Severe 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Besifloxacin Vehicle
Hide Arm/Group Description

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

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 (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      0/72 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Besifloxacin Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/64 (3.13%)      3/72 (4.17%)    
Eye disorders     
Conjunctivitis  [1]  2/64 (3.13%)  2 1/72 (1.39%)  1
Eye Pain  [2]  0/64 (0.00%)  0 2/72 (2.78%)  2
Indicates events were collected by systematic assessment
[1]
Fellow Eye
[2]
Treated Eye
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Johnson Varughese
Organization: Valeant Pharmaceuticals
Phone: 908-541-2179
EMail: Johnson.Varughese@valeant.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01740388     History of Changes
Other Study ID Numbers: 801
First Submitted: November 29, 2012
First Posted: December 4, 2012
Results First Submitted: September 11, 2014
Results First Posted: September 17, 2014
Last Update Posted: October 1, 2014