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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00348348
• Collaborator: (none)
• Enrollment: 1,161
• Arms: 2
• Duration (Months): 13

Study Details

Study Description

Brief Summary

This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.

Condition or Disease	Intervention/Treatment	Phase
Acute Bacterial Conjunctivitis	Drug: Besifloxacin; Drug: Moxifloxacin solution	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1161 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the Treatment of Bacterial Conjunctivitis
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Moxifloxacin solution Moxifloxacin hydrochloride ophthalmic solution 0.5%	Drug: Moxifloxacin solution; Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
Experimental: Besifloxacin Suspension Besifloxacin hydrochloride ophthalmic suspension 0.6%	Drug: Besifloxacin; Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days

Outcome Measures

Primary Outcome Measures

1. Clinical Resolution [Day 5(+/- 1 day)]

   Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)

2. Microbial Eradication [Day 5 (+/- 1 day)]

   eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated

Secondary Outcome Measures

1. Clinical Resolution [Day 8 or Day 9]

   Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated

2. Microbial Eradication [Day 8 or Day 9]

   Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

Exclusion Criteria:

• Pregnant or nursing females.

• Use of any antibiotic within 72 hours of enrollment.

• Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.

• Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Timothy Comstock, OD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00348348
• Other Study ID Numbers: 434
• First Posted: Jul 4, 2006
• Last Update Posted: Mar 24, 2015
• Last Verified: Mar 1, 2015

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

Study Results

Participant Flow

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 Detail	1161 participants were randomized of which 533 had culture confirmed bacterial conjunctivitis.

Arm/Group Title	Moxifloxacin Solution	Besifloxacin Suspension
Arm/Group Description	Moxifloxacin hydrochloride ophthalmic solution 0.5%	Besifloxacin ophthalmic suspension 0.6%
Period Title: Overall Study
STARTED	579	582
COMPLETED	554	555
NOT COMPLETED	25	27

Baseline Characteristics

Arm/Group Title	Moxifloxacin Solution	Besifloxacin Suspension	Total
Arm/Group Description	Moxifloxacin hydrochloride ophthalmic solution 0.5%	Besifloxacin ophthalmic suspension 0.6%	Total of all reporting groups
Overall Participants	579	582	1161
Age, Customized (participants) [Number]
<2 years	15 2.6%	22 3.8%	37 3.2%
2 to 9 years	90 15.5%	91 15.6%	181 15.6%
10 to 19 years	81 14%	75 12.9%	156 13.4%
20 to 29 years	73 12.6%	93 16%	166 14.3%
30 to 39 years	76 13.1%	71 12.2%	147 12.7%
40 to 49 years	59 10.2%	68 11.7%	127 10.9%
50 to 59 years	65 11.2%	63 10.8%	128 11%
>/= 60 years	120 20.7%	99 17%	219 18.9%
Sex: Female, Male (Count of Participants)
Female	323 55.8%	332 57%	655 56.4%
Male	256 44.2%	250 43%	506 43.6%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaskan Native	6 1%	3 0.5%	9 0.8%
Asian	89 15.4%	87 14.9%	176 15.2%
Black or African American	63 10.9%	73 12.5%	136 11.7%
Native Hawaiian or Pacific Islander	2 0.3%	5 0.9%	7 0.6%
White	391 67.5%	385 66.2%	776 66.8%
Other	28 4.8%	29 5%	57 4.9%

Outcome Measures

1. Primary Outcome

Title	Clinical Resolution
Description	Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Time Frame	Day 5(+/- 1 day)

Outcome Measure Data

Analysis Population Description

modified intent to treat (mITT), culture confirmed, as treated

Arm/Group Title	Moxifloxacin Solution	Besifloxacin Suspension
Arm/Group Description	Moxifloxacin hydrochloride ophthalmic solution 0.5%	Besifloxacin ophthalmic suspension 0.6%
Measure Participants	281	252
Number [Participants]	167 28.8%	147 25.3%

2. Primary Outcome

Title	Microbial Eradication
Description	eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time Frame	Day 5 (+/- 1 day)

Outcome Measure Data

Analysis Population Description

modified intent to treat (mITT), culture confirmed, as treated

Arm/Group Title	Moxifloxacin Solution	Besifloxacin Suspension
Arm/Group Description	Moxifloxacin hydrochloride ophthalmic solution 0.5%	Besifloxacin ophthalmic suspension 0.6%
Measure Participants	281	252
Number [Participants]	256 44.2%	235 40.4%

3. Secondary Outcome

Title	Clinical Resolution
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

Outcome Measure Data

Analysis Population Description

modified intent to treat (mITT), culture confirmed, as treated

Arm/Group Title	Moxifloxacin Solution	Besifloxacin Suspension
Arm/Group Description	Moxifloxacin hydrochloride ophthalmic solution 0.5%	Besifloxacin ophthalmic suspension 0.6%
Measure Participants	281	252
Number [Participants]	236 40.8%	213 36.6%

4. Secondary Outcome

Title	Microbial Eradication
Description	Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time Frame	Day 8 or Day 9

Outcome Measure Data

Analysis Population Description

modified intent to treat (mITT), culture confirmed, as treated

Arm/Group Title	Moxifloxacin Solution	Besifloxacin Suspension
Arm/Group Description	Moxifloxacin hydrochloride ophthalmic solution 0.5%	Besifloxacin ophthalmic suspension 0.6%
Measure Participants	281	252
Number [Participants]	238 41.1%	220 37.8%

Adverse Events

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
Arm/Group Description	Moxifloxacin hydrochloride ophthalmic solution 0.5%		Besifloxacin ophthalmic suspension 0.6%
All Cause Mortality
	Moxifloxacin Solution		Besifloxacin Suspension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Moxifloxacin Solution		Besifloxacin Suspension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/579 (0.2%)		1/582 (0.2%)
Cardiac disorders
Congestive heart failure	1/579 (0.2%)	1	1/582 (0.2%)	1
Infections and infestations
Acute viral syndrome	1/579 (0.2%)	1	1/582 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Moxifloxacin Solution		Besifloxacin Suspension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/855 (0%)		0/865 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor has 45 days to review materials and provide comments back to the investigator.