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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01740388
• Collaborator: (none)
• Enrollment: 136
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 15.2

Study Details

Study Description

Brief Summary

To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6% (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial conjunctivitis.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Conjunctivitis	Drug: Besifloxacin; Drug: Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 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: Feb 1, 2013
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Besifloxacin besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis	Drug: Besifloxacin; one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.; Other Names: Besivance
Placebo Comparator: Vehicle vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis	Drug: Vehicle; one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Outcome Measures

Primary Outcome Measures

1. Clinical Resolution [Visit 2 (Day 4 or 5)]

   Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%

2. Microbial Eradication [Visit 2 (Day 4 or 5)]

   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%

Secondary Outcome Measures

1. Clinical Resolution [Visit 3 (Day 6, 7, or 8)]

   Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%

2. Microbial Eradication [Visit 3 (Day 6, 7, or 8)]

   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%

Other Outcome Measures

1. Ocular Conjunctival Discharge [At each follow-up visit (Visit 1, Visit 2 and Visit 3)]

   Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe

2. Bulbar Conjunctival Injection [At each follow-up visit (Visit 1, Visit 2 and Visit 3)]

   Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent/purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least 1 eye. A minimum score of 1 should be present for both discharge and for bulbar conjunctival injection.

• Have monocular pin-holed Snellen visual acuity (VA) equal to or better than 20/200 in both eyes. Age appropriate VA testing will be performed. Every effort should be made to obtain a VA measurement in children. If VA is unobtainable in children, it is at the Investigator's discretion to include the subject in the study.

• Be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

• Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.

• Have a known hypersensitivity or contraindications to besifloxacin, fluoroquinolones, or any of the ingredients in the study drugs.

• Be expected to require treatment with systemic or ocular (either eye) nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, or corticosteroids during the study or have used any of these medications within 2 days prior to study start.

• Be expected to require concurrent ocular therapy in either eye with any ophthalmic solutions (unless specified below), including tear substitutes, during the study or have used any ophthalmic solutions within 2 hours prior to study start. Be expected to require concurrent ocular therapy (either eye) with mast cell stabilizers or decongestants during the study or have used any of the above within 2 days prior to study start.

• Be expected to require concurrent systemic or ocular therapy with immunosuppressants (eg, Restasis) during the study or have used systemic or ocular immunosuppressants within 30 days prior to study start.

• Be expected to require treatment with systemic or ocular (either eye) antibacterials (other than study drug) during the study or have used any systemic or ocular antibacterial within 3 days prior to study start.

• Be likely to require antimicrobial therapy for conditions such as respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media during the study.

• Have had ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.

• Have suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.

• Have suspected iritis

• Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.

• Have any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.

• Be immune compromised.

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: Johnson Varughese, Valeant Pharmaceuticals/Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01740388
• Other Study ID Numbers: 801
• First Posted: Dec 4, 2012
• Last Update Posted: Oct 1, 2014
• Last Verified: Sep 1, 2014

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

Study Results

Participant Flow

Arm/Group Title	Besifloxacin	Vehicle
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

Baseline Characteristics

Arm/Group Title	Besifloxacin	Vehicle	Total
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 Participants	64	72	136
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.6 (22.52)	50.6 (21.36)	47.8 (22.03)
Sex: Female, Male (Count of Participants)
Female	44 68.8%	44 61.1%	88 64.7%
Male	20 31.3%	28 38.9%	48 35.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	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%
Unknown or Not Reported	4 6.3%	1 1.4%	5 3.7%

Outcome Measures

1. Primary Outcome

Title	Clinical Resolution
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)

Outcome Measure Data

Analysis Population Description

Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])

Arm/Group Title	Besifloxacin	Vehicle
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.
Measure Participants	18	28
YES	4 6.3%	5 6.9%
NO	14 21.9%	23 31.9%

2. Primary Outcome

Title	Microbial Eradication
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)

Outcome Measure Data

Analysis Population Description

Analysis population is only Subjects with non-missing data, Microbial Eradication (LOCF [Last Observation Carried Forward])

Arm/Group Title	Besifloxacin	Vehicle
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.
Measure Participants	18	28
YES	17 26.6%	13 18.1%
NO	1 1.6%	15 20.8%

3. Secondary Outcome

Title	Clinical Resolution
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)

Outcome Measure Data

Analysis Population Description

Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])

Arm/Group Title	Besifloxacin	Vehicle
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.
Measure Participants	18	28
YES	6 9.4%	13 18.1%
NO	12 18.8%	15 20.8%

4. Secondary Outcome

Title	Microbial Eradication
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Besifloxacin	Vehicle
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.
Measure Participants	18	28
YES	14 21.9%	16 22.2%
NO	4 6.3%	12 16.7%

5. Other Pre-specified Outcome

Title	Ocular Conjunctival Discharge
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)

Outcome Measure Data

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
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.
Measure Participants	18	28
Visit 1: Absent	0 0%	0 0%
Visit 1: Mild	6 9.4%	9 12.5%
Visit 1: Moderate	10 15.6%	16 22.2%
Visit 1: Severe	2 3.1%	3 4.2%
Visit 2: Absent	9 14.1%	10 13.9%
Visit 2: Mild	8 12.5%	15 20.8%
Visit 2: Moderate	1 1.6%	2 2.8%
Visit 2: Severe	0 0%	0 0%
Visit 3: Absent	14 21.9%	16 22.2%
Visit 3: Mild	4 6.3%	5 6.9%
Visit 3: Moderate	0 0%	3 4.2%
Visit 3: Severe	0 0%	0 0%

6. Other Pre-specified Outcome

Title	Bulbar Conjunctival Injection
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Besifloxacin	Vehicle
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.
Measure Participants	18	28
Visit 1: Normal	0 0%	0 0%
Visit 1: Mild	3 4.7%	6 8.3%
Visit 1: Moderate	14 21.9%	18 25%
Visit 1: Severe	1 1.6%	4 5.6%
Visit 2: Normal	4 6.3%	7 9.7%
Visit 2: Mild	13 20.3%	12 16.7%
Visit 2: Moderate	1 1.6%	8 11.1%
Visit 2: Severe	0 0%	0 0%
Visit 3: Normal	7 10.9%	12 16.7%
Visit 3: Mild	11 17.2%	6 8.3%
Visit 3: Moderate	0 0%	5 6.9%
Visit 3: Severe	0 0%	1 1.4%

Adverse Events

Arm/Group Title	Besifloxacin		Vehicle
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Besifloxacin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Besifloxacin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/64 (3.1%)		3/72 (4.2%)
Eye disorders
Conjunctivitis	2/64 (3.1%)	2	1/72 (1.4%)	1
Eye Pain	0/64 (0%)	0	2/72 (2.8%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.