Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00972777
• Collaborator: (none)
• Enrollment: 474
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 29.6

Study Details

Study Description

Brief Summary

This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Conjunctivitis	Drug: Besifloxacin; Drug: Vehicle (Placebo)	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 474 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% BID Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Besifloxacin 0.6% ophthalmic suspension	Drug: Besifloxacin; Besifloxacin 0.6% administered into the study eye two times a day for three days.; Other Names: Besivance
Placebo Comparator: Vehicle	Drug: Vehicle (Placebo); Vehicle administered to the study eye two times a day for three days.

Outcome Measures

Primary Outcome Measures

1. Clinical Resolution [Visit 2]

   The absence of both conjunctival discharge and bulbar conjunctival injection.

2. Microbial Eradication [Visit 2]

   The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.

Secondary Outcome Measures

1. Clinical Resolution [Visit 3]

   The absence of both conjunctival discharge and bulbar conjunctival injection.

2. Microbial Eradication [Visit 3]

   The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects who are at least one year of age.

• Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.

• Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

• Subjects who have any uncontrolled systemic disease or debilitating disease.

• Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.

• Subjects who are expected to require treatment with any disallowed medications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb Incorporated	Rochester	New York	United States	14609

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Michael R Paterno, OD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00972777
• Other Study ID Numbers: 603
• First Posted: Sep 9, 2009
• Last Update Posted: Mar 29, 2012
• Last Verified: Feb 1, 2012

• Additional relevant MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis; Besifloxacin

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Besifloxacin	Vehicle	Total
Arm/Group Description	0.6% ophthalmic suspension	Vehicle of besifloxacin ophthalmic suspension	Total of all reporting groups
Overall Participants	231	243	474
Age, Customized (participants) [Number]
<2 years	14 6.1%	13 5.3%	27 5.7%
2 - 11 years	66 28.6%	77 31.7%	143 30.2%
12 - 17 years	19 8.2%	20 8.2%	39 8.2%
18 - 29 years	32 13.9%	40 16.5%	72 15.2%
30 - 39 years	21 9.1%	29 11.9%	50 10.5%
40 - 49 years	23 10%	14 5.8%	37 7.8%
50 - 59 years	20 8.7%	19 7.8%	39 8.2%
>=60 years	35 15.2%	31 12.8%	66 13.9%
Missing	1 0.4%	0 0%	1 0.2%
Sex: Female, Male (Count of Participants)
Female	142 61.5%	133 54.7%	275 58%
Male	89 38.5%	110 45.3%	199 42%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	7 3%	5 2.1%	12 2.5%
Asian	7 3%	7 2.9%	14 3%
Native Hawaiian or Other Pacific Islander	0 0%	2 0.8%	2 0.4%
Black or African American	45 19.5%	58 23.9%	103 21.7%
White	167 72.3%	166 68.3%	333 70.3%
Other	4 1.7%	5 2.1%	9 1.9%
Missing	1 0.4%	0 0%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Clinical Resolution
Description	The absence of both conjunctival discharge and bulbar conjunctival injection.
Time Frame	Visit 2

Outcome Measure Data

Analysis Population Description

Clinical Resolution at Visit 2, (LOCF), mITT Population.

Arm/Group Title	Besifloxacin	Vehicle
Arm/Group Description	0.6% ophthalmic suspension	Vehicle of besifloxacin ophthalmic suspension
Measure Participants	135	141
Number [eyes]	89	62

2. Primary Outcome

Title	Microbial Eradication
Description	The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time Frame	Visit 2

Outcome Measure Data

Analysis Population Description

Microbial Eradication at Visit 2, (LOCF), mITT Population.

Arm/Group Title	Besifloxacin	Vehicle
Arm/Group Description	0.6% ophthalmic suspension	Vehicle of besifloxacin ophthalmic suspension
Measure Participants	135	141
Number [eyes]	115	77

3. Secondary Outcome

Title	Clinical Resolution
Description	The absence of both conjunctival discharge and bulbar conjunctival injection.
Time Frame	Visit 3

Outcome Measure Data

Analysis Population Description

Clinical Resolution at Visit 3, (LOCF) mITT Population.

Arm/Group Title	Besifloxacin	Vehicle
Arm/Group Description	0.6% ophthalmic suspension	Vehicle of besifloxacin ophthalmic suspension
Measure Participants	135	141
Number [eyes]	103	94

4. Secondary Outcome

Title	Microbial Eradication
Description	The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time Frame	Visit 3

Outcome Measure Data

Analysis Population Description

Microbial Eradication at Visit 3, (LOCF), mITT Population.

Arm/Group Title	Besifloxacin	Vehicle
Arm/Group Description	0.6% ophthalmic suspension	Vehicle of besifloxacin ophthalmic suspension
Measure Participants	135	141
Number [eyes]	115	91

Adverse Events

Time Frame	7 days
Adverse Event Reporting Description	Safety Population, participants receiving at least one drop of study medication.
Arm/Group Title	Besifloxacin		Vehicle
Arm/Group Description	0.6% ophthalmic suspension		Vehicle of besifloxacin ophthalmic suspension
All Cause Mortality
	Besifloxacin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Besifloxacin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/228 (0%)		0/236 (0%)
Other (Not Including Serious) Adverse Events
	Besifloxacin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/228 (0%)		0/236 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.