Trial Outcomes & Findings for Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle (NCT NCT01175590)

NCT ID: NCT01175590

Last Updated: 2013-05-01

Results Overview

Ocular Treatment-Emergent Adverse Events on the Study Eye

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

518 participants

Primary outcome timeframe

At each visit - 7 days

Results posted on

2013-05-01

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Besivance besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days
Overall Study STARTED	347	171
Overall Study Modified Intent to Treat Population	212	87
Overall Study Safety Population	344	170
Overall Study COMPLETED	335	161
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Besivance besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Adverse Event	4	0
Overall Study Physician Decision	1	4
Overall Study Lack of Efficacy	1	1
Overall Study Residual Bacterial Conjunctivitis	1	0
Overall Study Treated not as randomized	3	2
Overall Study Herpes Simplex Dermatitis	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Besivance n=347 Participants besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle n=171 Participants Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days	Total n=518 Participants Total of all reporting groups
Age, Customized 0-17 years	149 participants n=39 Participants	62 participants n=41 Participants	211 participants n=35 Participants
Age, Customized 18 - 49 years	106 participants n=39 Participants	71 participants n=41 Participants	177 participants n=35 Participants
Age, Customized >=50 years	92 participants n=39 Participants	38 participants n=41 Participants	130 participants n=35 Participants
Sex: Female, Male Female	205 Participants n=39 Participants	95 Participants n=41 Participants	300 Participants n=35 Participants
Sex: Female, Male Male	142 Participants n=39 Participants	76 Participants n=41 Participants	218 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=39 Participants	3 Participants n=41 Participants	10 Participants n=35 Participants
Race (NIH/OMB) Asian	5 Participants n=39 Participants	5 Participants n=41 Participants	10 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Black or African American	83 Participants n=39 Participants	40 Participants n=41 Participants	123 Participants n=35 Participants
Race (NIH/OMB) White	213 Participants n=39 Participants	103 Participants n=41 Participants	316 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	39 Participants n=39 Participants	19 Participants n=41 Participants	58 Participants n=35 Participants

PRIMARY outcome

Timeframe: At each visit - 7 days

Population: Safety Population

Ocular Treatment-Emergent Adverse Events on the Study Eye

Outcome measures

Outcome measures
Measure	Besivance n=344 eyes besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle n=170 eyes Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days
Ocular Treatment Emergent Adverse Events Conjunctivitis	3 Events Interval 0.2 to 3.0	3 Events Interval 0.4 to 5.1
Ocular Treatment Emergent Adverse Events Blepharitis	1 Events Interval 0.0 to 1.6	1 Events Interval 0.0 to 3.2
Ocular Treatment Emergent Adverse Events Conjunctival Oedema	1 Events Interval 0.0 to 1.6	1 Events Interval 0.0 to 3.2
Ocular Treatment Emergent Adverse Events Erythema of Eyelid	2 Events Interval 0.1 to 2.1	0 Events Interval 0.0 to 0.0
Ocular Treatment Emergent Adverse Events Punctate Keratitis	1 Events Interval 0.0 to 1.6	1 Events Interval 0.0 to 3.2
Ocular Treatment Emergent Adverse Events Conjunctival Haemorrhage	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Ocular Treatment Emergent Adverse Events Conjunctivitis Allergic	0 Events Interval 0.0 to 0.0	1 Events Interval 0.0 to 3.2
Ocular Treatment Emergent Adverse Events Corneal Infiltrates	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Ocular Treatment Emergent Adverse Events Dacryocystitis	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Ocular Treatment Emergent Adverse Events Eye Pain	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Ocular Treatment Emergent Adverse Events Lacrimation Increased	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Ocular Treatment Emergent Adverse Events Scleritis	0 Events Interval 0.0 to 0.0	1 Events Interval 0.0 to 3.2
Ocular Treatment Emergent Adverse Events Instillation Site Reaction	2 Events Interval 0.1 to 2.1	1 Events Interval 0.0 to 3.2
Ocular Treatment Emergent Adverse Events Instillation Site Erythema	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Ocular Treatment Emergent Adverse Events Instillation Site Irritation	0 Events Interval 0.0 to 0.0	1 Events Interval 0.0 to 3.2
Ocular Treatment Emergent Adverse Events Instillation Site Pain	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Ocular Treatment Emergent Adverse Events Pain	0 Events Interval 0.0 to 0.0	1 Events Interval 0.0 to 3.2
Ocular Treatment Emergent Adverse Events Herpes Dermatitis	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Ocular Treatment Emergent Adverse Events Post-Traumatic Pain	0 Events Interval 0.0 to 0.0	1 Events Interval 0.0 to 3.2
Ocular Treatment Emergent Adverse Events Corneal Staining	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 7 days

Population: Safety Population

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

Outcome measures

Outcome measures
Measure	Besivance n=344 Participants besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle n=170 Participants Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days
Non-Ocular Treatment-Emergent Adverse Events Ear Pain	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Non-Ocular Treatment-Emergent Adverse Events Dysgeusia	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Non-Ocular Treatment-Emergent Adverse Events Pyrexia	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Non-Ocular Treatment-Emergent Adverse Events Nasopharyngitis	2 Events Interval 0.1 to 2.1	1 Events Interval 0.0 to 3.2
Non-Ocular Treatment-Emergent Adverse Events Bronchitis	0 Events Interval 0.0 to 0.0	1 Events Interval 0.0 to 3.2
Non-Ocular Treatment-Emergent Adverse Events Gastroenteritis, Viral	0 Events Interval 0.0 to 0.0	1 Events Interval 0.0 to 3.2
Non-Ocular Treatment-Emergent Adverse Events Otitis Media	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0
Non-Ocular Treatment-Emergent Adverse Events Upper Respiratory Tract Infection	1 Events Interval 0.0 to 1.6	0 Events Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 8 (Visit 2)

Population: Study eye for the mITT population

The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data

Outcome measures

Outcome measures
Measure	Besivance n=206 eyes besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle n=83 eyes Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days
Clinical Resolution	112 eyes	46 eyes

SECONDARY outcome

Timeframe: Day 11 (Visit 3)

Population: Study eye for the mITT population

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

Outcome measures

Outcome measures
Measure	Besivance n=204 Participants besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle n=84 Participants Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days
Clinical Resolution	169 eyes	68 eyes

SECONDARY outcome

Timeframe: Days 8 (Visit 2)

Population: Study Eye, Modified Intent-to-Treat Population

The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.

Outcome measures

Outcome measures
Measure	Besivance n=206 eyes besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle n=80 eyes Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days
Microbial Eradication	172 eyes	36 eyes

SECONDARY outcome

Timeframe: Days 11 (Visit 3)

Population: Study Eye, Modified Intent-to-Treat Population

The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.

Outcome measures

Outcome measures
Measure	Besivance n=200 eyes besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle n=83 eyes Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days
Microbial Eradication	169 eyes	48 eyes

SECONDARY outcome

Timeframe: Day 8 (Visit 2)

Population: Modified Intent-to-Treat Population

At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline

Outcome measures

Outcome measures
Measure	Besivance n=206 Participants besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days	Vehicle n=80 Participants Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days
Microbial Outcome With Clinical Resolution Clinical Resolution with Microbial Eradication	96 eyes	22 eyes
Microbial Outcome With Clinical Resolution Clinical Resolution with no Microbial Eradication	16 eyes	24 eyes
Microbial Outcome With Clinical Resolution No Clinical Resolution with Microbial Eradication	76 eyes	14 eyes
Microbial Outcome With Clinical Resolution No Clinical Resolution no Microbial Eradication	18 eyes	20 eyes

SECONDARY outcome

Timeframe: Day 11 (Visit 3)

Population: Modified Intent-to-Treat Population

At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline