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

A Study to Evaluate the Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Following Three Times Daily(TID) Dosing for 7 Days

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01175590

Enrollment

518

Registered

2010-08-05

Start date

2010-06-30

Completion date

2012-02-29

Last updated

2013-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Conjunctivitis

Brief summary

The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.

Interventions

DRUGBesivance

Ocular administration to affected eye for 7 days

DRUGVehicle

Vehicle of Besivance administered to affected eye for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. * Subjects who are willing to discontinue contact lens wear for the duration of the study. * Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion criteria

* Subjects who have any uncontrolled systemic disease or debilitating disease. * Subjects with a known hypersensitivity or contraindications to Besivance, fluoroquinolones, or any of the ingredients in the study drugs. * Subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy) * Subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study. * Subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication. * Subjects with suspected iritis. * Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome. * Subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis. * Subjects who are immune compromised.

Design outcomes

Primary

Measure	Time frame	Description
Ocular Treatment Emergent Adverse Events	At each visit - 7 days	Ocular Treatment-Emergent Adverse Events on the Study Eye
Non-Ocular Treatment-Emergent Adverse Events	7 days	Non-Ocular Treatment-Emergent Adverse Events on the Study Eye

Secondary

Measure	Time frame	Description
Microbial Eradication	Days 8 (Visit 2)	The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Individual Clinical Outcomes - Bulbar Injection	At day 1 (Vist 1)	Bulbar conjunctival injection measured as normal, mild, moderate or severe
Individual Clinical Outcomes - Ocular Discharge	At day 1 (Vist 1)	ocular conjunctival discharge measured as absent, mild, moderate or severe
Microbial Outcome With Clinical Resolution	Day 8 (Visit 2)	At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Clinical Resolution	Day 8 (Visit 2)	The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data

Countries

United States

Participant flow

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).

Participants by arm

Arm	Count
Besivance besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	347
Vehicle Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days	171
Total	518

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	4	0
Overall Study	Herpes Simplex Dermatitis	1	0
Overall Study	Lack of Efficacy	1	1
Overall Study	Lost to Follow-up	1	0
Overall Study	Physician Decision	1	4
Overall Study	Protocol Violation	0	1
Overall Study	Residual Bacterial Conjunctivitis	1	0
Overall Study	Treated not as randomized	3	2
Overall Study	Withdrawal by Subject	0	2

Baseline characteristics

Characteristic	Total	Besivance	Vehicle
Age, Customized 0-17 years	211 participants	149 participants	62 participants
Age, Customized 18 - 49 years	177 participants	106 participants	71 participants
Age, Customized >=50 years	130 participants	92 participants	38 participants
Race (NIH/OMB) American Indian or Alaska Native	10 Participants	7 Participants	3 Participants
Race (NIH/OMB) Asian	10 Participants	5 Participants	5 Participants
Race (NIH/OMB) Black or African American	123 Participants	83 Participants	40 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	58 Participants	39 Participants	19 Participants
Race (NIH/OMB) White	316 Participants	213 Participants	103 Participants
Sex: Female, Male Female	300 Participants	205 Participants	95 Participants
Sex: Female, Male Male	218 Participants	142 Participants	76 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 347	0 / 171
serious Total, serious adverse events	0 / 347	0 / 171

Outcome results

Primary

Non-Ocular Treatment-Emergent Adverse Events

Non-Ocular Treatment-Emergent Adverse Events on the Study Eye

Time frame: 7 days

Population: Safety Population

Arm	Measure	Group	Value (NUMBER)
Besivance	Non-Ocular Treatment-Emergent Adverse Events	Ear Pain	1 Events
Besivance	Non-Ocular Treatment-Emergent Adverse Events	Dysgeusia	1 Events
Besivance	Non-Ocular Treatment-Emergent Adverse Events	Pyrexia	1 Events
Besivance	Non-Ocular Treatment-Emergent Adverse Events	Nasopharyngitis	2 Events
Besivance	Non-Ocular Treatment-Emergent Adverse Events	Bronchitis	0 Events
Besivance	Non-Ocular Treatment-Emergent Adverse Events	Gastroenteritis, Viral	0 Events
Besivance	Non-Ocular Treatment-Emergent Adverse Events	Otitis Media	1 Events
Besivance	Non-Ocular Treatment-Emergent Adverse Events	Upper Respiratory Tract Infection	1 Events
Vehicle	Non-Ocular Treatment-Emergent Adverse Events	Upper Respiratory Tract Infection	0 Events
Vehicle	Non-Ocular Treatment-Emergent Adverse Events	Ear Pain	0 Events
Vehicle	Non-Ocular Treatment-Emergent Adverse Events	Bronchitis	1 Events
Vehicle	Non-Ocular Treatment-Emergent Adverse Events	Dysgeusia	0 Events
Vehicle	Non-Ocular Treatment-Emergent Adverse Events	Otitis Media	0 Events
Vehicle	Non-Ocular Treatment-Emergent Adverse Events	Pyrexia	0 Events
Vehicle	Non-Ocular Treatment-Emergent Adverse Events	Gastroenteritis, Viral	1 Events
Vehicle	Non-Ocular Treatment-Emergent Adverse Events	Nasopharyngitis	1 Events

Primary

Ocular Treatment Emergent Adverse Events

Ocular Treatment-Emergent Adverse Events on the Study Eye

Time frame: At each visit - 7 days

Population: Safety Population

Arm	Measure	Group	Value (NUMBER)
Besivance	Ocular Treatment Emergent Adverse Events	Lacrimation Increased	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Conjunctival Haemorrhage	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Scleritis	0 Events
Besivance	Ocular Treatment Emergent Adverse Events	Blepharitis	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Instillation Site Reaction	2 Events
Besivance	Ocular Treatment Emergent Adverse Events	Conjunctivitis Allergic	0 Events
Besivance	Ocular Treatment Emergent Adverse Events	Instillation Site Erythema	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Erythema of Eyelid	2 Events
Besivance	Ocular Treatment Emergent Adverse Events	Instillation Site Irritation	0 Events
Besivance	Ocular Treatment Emergent Adverse Events	Corneal Infiltrates	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Instillation Site Pain	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Conjunctivitis	3 Events
Besivance	Ocular Treatment Emergent Adverse Events	Pain	0 Events
Besivance	Ocular Treatment Emergent Adverse Events	Dacryocystitis	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Herpes Dermatitis	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Punctate Keratitis	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Post-Traumatic Pain	0 Events
Besivance	Ocular Treatment Emergent Adverse Events	Eye Pain	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Corneal Staining	1 Events
Besivance	Ocular Treatment Emergent Adverse Events	Conjunctival Oedema	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Corneal Staining	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Blepharitis	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Conjunctival Oedema	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Erythema of Eyelid	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Punctate Keratitis	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Conjunctival Haemorrhage	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Conjunctivitis Allergic	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Corneal Infiltrates	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Dacryocystitis	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Eye Pain	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Lacrimation Increased	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Scleritis	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Instillation Site Reaction	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Instillation Site Erythema	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Instillation Site Irritation	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Instillation Site Pain	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Pain	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Herpes Dermatitis	0 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Post-Traumatic Pain	1 Events
Vehicle	Ocular Treatment Emergent Adverse Events	Conjunctivitis	3 Events

Secondary

Clinical Resolution

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)

Population: Study eye for the mITT population

Arm	Measure	Value (NUMBER)
Besivance	Clinical Resolution	112 eyes
Vehicle	Clinical Resolution	46 eyes

Secondary

Clinical Resolution

The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.

Time frame: Day 11 (Visit 3)

Population: Study eye for the mITT population

Arm	Measure	Value (NUMBER)
Besivance	Clinical Resolution	169 eyes
Vehicle	Clinical Resolution	68 eyes

Secondary