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Trial record 24 of 26 for:    "Bacterial Conjunctivitis" | "Anti-Bacterial Agents"

Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle

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ClinicalTrials.gov Identifier: NCT01175590
Recruitment Status : Completed
First Posted : August 5, 2010
Results First Posted : May 1, 2013
Last Update Posted : May 1, 2013
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: Besivance
Drug: Vehicle
Enrollment 518
Recruitment Details First participant entered the study 6/22/2010 and the last participant visit was 12/12/2011. Twenty four sites in the United States participated in the study.
Pre-assignment Details 518 participants with a clinical diagnosis of bacterial conjunctivitis were enrolled in the study, 496 completed the study; 518 participants were in Intent-to-Treat (ITT) population, 514 participants were in Safety population, and 299 participants were in modified Intent-to-Treat (mITT) population (Participants with positive culture at baseline).
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Period Title: Overall Study
Started 347 171
Modified Intent to Treat Population 212 87
Safety Population 344 170
Completed 335 161
Not Completed 12 10
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             0             2
Adverse Event             4             0
Physician Decision             1             4
Lack of Efficacy             1             1
Residual Bacterial Conjunctivitis             1             0
Treated not as randomized             3             2
Herpes Simplex Dermatitis             1             0
Protocol Violation             0             1
Arm/Group Title Besivance Vehicle Total
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besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Total of all reporting groups
Overall Number of Baseline Participants 347 171 518
Hide Baseline Analysis Population Description
Intent to treat population (ITT)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 171 participants 518 participants
0-17 years 149 62 211
18 - 49 years 106 71 177
>=50 years 92 38 130
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants 171 participants 518 participants
Female
205
  59.1%
95
  55.6%
300
  57.9%
Male
142
  40.9%
76
  44.4%
218
  42.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants 171 participants 518 participants
American Indian or Alaska Native
7
   2.0%
3
   1.8%
10
   1.9%
Asian
5
   1.4%
5
   2.9%
10
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.6%
1
   0.2%
Black or African American
83
  23.9%
40
  23.4%
123
  23.7%
White
213
  61.4%
103
  60.2%
316
  61.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
39
  11.2%
19
  11.1%
58
  11.2%
1.Primary Outcome
Title Ocular Treatment Emergent Adverse Events
Hide Description Ocular Treatment-Emergent Adverse Events on the Study Eye
Time Frame At each visit - 7 days
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Safety Population
Arm/Group Title Besivance Vehicle
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besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 344 170
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
344 170
Measure Type: Number
Unit of Measure: Events
Conjunctivitis 3 3
Blepharitis 1 1
Conjunctival Oedema 1 1
Erythema of Eyelid 2 0
Punctate Keratitis 1 1
Conjunctival Haemorrhage 1 0
Conjunctivitis Allergic 0 1
Corneal Infiltrates 1 0
Dacryocystitis 1 0
Eye Pain 1 0
Lacrimation Increased 1 0
Scleritis 0 1
Instillation Site Reaction 2 1
Instillation Site Erythema 1 0
Instillation Site Irritation 0 1
Instillation Site Pain 1 0
Pain 0 1
Herpes Dermatitis 1 0
Post-Traumatic Pain 0 1
Corneal Staining 1 0
2.Primary Outcome
Title Non-Ocular Treatment-Emergent Adverse Events
Hide Description Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
Time Frame 7 days
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Safety Population
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 344 170
Measure Type: Number
Unit of Measure: Events
Ear Pain 1 0
Dysgeusia 1 0
Pyrexia 1 0
Nasopharyngitis 2 1
Bronchitis 0 1
Gastroenteritis, Viral 0 1
Otitis Media 1 0
Upper Respiratory Tract Infection 1 0
3.Secondary Outcome
Title Clinical Resolution
Hide Description The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data
Time Frame Day 8 (Visit 2)
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Hide Analysis Population Description
Study eye for the mITT population
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 206 83
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
206 83
Measure Type: Number
Unit of Measure: eyes
112 46
4.Secondary Outcome
Title Clinical Resolution
Hide Description The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
Time Frame Day 11 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Study eye for the mITT population
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 204 84
Measure Type: Number
Unit of Measure: eyes
169 68
5.Secondary Outcome
Title Microbial Eradication
Hide Description The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Time Frame Days 8 (Visit 2)
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Hide Analysis Population Description
Study Eye, Modified Intent-to-Treat Population
Arm/Group Title Besivance Vehicle
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besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 206 80
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
206 80
Measure Type: Number
Unit of Measure: eyes
172 36
6.Secondary Outcome
Title Microbial Eradication
Hide Description The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Time Frame Days 11 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Study Eye, Modified Intent-to-Treat Population
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 200 83
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
200 83
Measure Type: Number
Unit of Measure: eyes
169 48
7.Secondary Outcome
Title Microbial Outcome With Clinical Resolution
Hide Description At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Time Frame Day 8 (Visit 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 206 80
Measure Type: Number
Unit of Measure: eyes
Clinical Resolution with Microbial Eradication 96 22
Clinical Resolution with no Microbial Eradication 16 24
No Clinical Resolution with Microbial Eradication 76 14
No Clinical Resolution no Microbial Eradication 18 20
8.Secondary Outcome
Title Microbial Outcome With Clinical Resolution
Hide Description At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Time Frame Day 11 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 200 83
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
200 83
Measure Type: Number
Unit of Measure: eyes
Clinical Resolution with Microbial Eradication 143 42
Clinical Resolution with no Microbial Eradication 23 25
No Clinical Resolution with Microbial Eradication 26 6
No Clinical Resolution no Microbial Eradication 8 10
9.Secondary Outcome
Title Individual Clinical Outcomes - Ocular Discharge
Hide Description ocular conjunctival discharge measured as absent, mild, moderate or severe
Time Frame At day 1 (Vist 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline-Designated Study Eye (Modified Intent-to- Treat Population)
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 212 87
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
212 87
Measure Type: Number
Unit of Measure: eyes
Absent 0 0
Mild 94 38
Moderate 106 44
Severe 12 5
10.Secondary Outcome
Title Individual Clinical Outcomes - Ocular Discharge
Hide Description ocular conjunctival discharge measured as absent, mild, moderate or severe
Time Frame At day 8 (Vist 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline-Designated Study Eye (Modified Intent-to- Treat Population)
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 206 83
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
206 83
Measure Type: Number
Unit of Measure: eyes
Absent 155 61
Mild 42 18
Moderate 8 4
Severe 1 0
11.Secondary Outcome
Title Individual Clinical Outcomes - Ocular Discharge
Hide Description ocular conjunctival discharge measured as absent, mild, moderate or severe
Time Frame At day 11 (Vist 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline-Designated Study Eye (Modified Intent-to- Treat Population)
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 204 84
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
204 84
Measure Type: Number
Unit of Measure: eyes
Absent 187 77
Mild 12 6
Moderate 4 1
Severe 1 0
12.Secondary Outcome
Title Individual Clinical Outcomes - Bulbar Injection
Hide Description Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time Frame At day 1 (Vist 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline-Designated Study Eye (Modified Intent-to- Treat Population)
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 212 87
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
212 87
Measure Type: Number
Unit of Measure: eyes
Normal 0 0
Mild 110 44
Moderate 83 37
Severe 19 6
13.Secondary Outcome
Title Individual Clinical Outcomes - Bulbar Injection
Hide Description Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time Frame At day 8 (Vist 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline-Designated Study Eye (Modified Intent-to- Treat Population)
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 206 83
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
206 83
Measure Type: Number
Unit of Measure: eyes
Normal 142 57
Mild 56 23
Moderate 7 3
Severe 1 0
14.Secondary Outcome
Title Individual Clinical Outcomes - Bulbar Injection
Hide Description Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time Frame At day 11 (Vist 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline-Designated Study Eye (Modified Intent-to- Treat Population)
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description:

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

Overall Number of Participants Analyzed 204 84
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
204 84
Measure Type: Number
Unit of Measure: eyes
Normal 182 72
Mild 18 11
Moderate 4 1
Severe 0 0
Time Frame 11 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Besivance Vehicle
Hide Arm/Group Description

besifloxacin ophthalmic suspension 0.6%

Besivance : Ocular administration to affected eye for 7 days

Vehicle of Besivance

Vehicle : Vehicle of Besivance administered to affected eye for 7 days

All-Cause Mortality
Besivance Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Besivance Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/347 (0.00%)   0/171 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Besivance Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/347 (0.00%)   0/171 (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.
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. Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee, for comment.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tuyen Ong, MD, MRCOphth
Organization: Bausch & Lomb Inc.
Phone: (973) 360-6389
EMail: tuyen.ong@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01175590     History of Changes
Other Study ID Numbers: 631
First Submitted: August 3, 2010
First Posted: August 5, 2010
Results First Submitted: February 13, 2013
Results First Posted: May 1, 2013
Last Update Posted: May 1, 2013