TerminatedNCT01740388Updated Oct 1, 2014Results posted

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

A Phase 3 interventional study of Besifloxacin and Vehicle in Bacterial Conjunctivitis, sponsored by Bausch & Lomb Incorporated. Terminated at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Treatment

Why this study was terminated

Strategic business decision

Phase: Phase 3
Study type: Interventional
Enrollment: 136
Allocation: Randomized
Ages: 1 Year and older
Sex: All

Study 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.

Conditions studied

Bacterial Conjunctivitis

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Conjunctivitis, Bacterial 40

In context

Conjunctivitis, Bacterial

40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.

This study's enrollment of 136 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.

Browse Conjunctivitis, Bacterial studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.

First submitted before Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..

Browse Bausch & Lomb Incorporated studies →All Bausch Health Companies Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Year and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 or 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 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 (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.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 136 participants (actual)

Study arms

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
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

Interventions

DrugBesifloxacin
one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
Also known as: Besivance
DrugVehicle
one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

What researchers measure

Primary outcomes

Clinical Resolution
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)
Microbial Eradication
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)

Secondary outcomes

Clinical Resolution
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)
Microbial Eradication
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)

Other outcomes

Ocular Conjunctival Discharge
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)
Bulbar Conjunctival Injection
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)

Results

Posted Sep 17, 2014

Participant flow

Participant flow — Overall Study
Milestone	Besifloxacin	Vehicle
Started	64	72
Completed	18	28
Not completed	46	44
Withdrew: Withdrawal by subject	1	2
Withdrew: Lost to follow-up	2	0
Withdrew: Physician decision	2	6
Withdrew: Subjects missing data, completed	41	36

Outcome measures

PrimaryClinical Resolution

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)
Reported as:: Number · participants

Clinical Resolution
participants	Besifloxacin	Vehicle
YES	4	5
NO	14	23

PrimaryMicrobial Eradication

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)
Reported as:: Number · participants

Microbial Eradication
participants	Besifloxacin	Vehicle
YES	17	13
NO	1	15

SecondaryClinical Resolution

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)
Reported as:: Number · participants

Clinical Resolution
participants	Besifloxacin	Vehicle
YES	6	13
NO	12	15

SecondaryMicrobial Eradication

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)
Reported as:: Number · participants

Microbial Eradication
participants	Besifloxacin	Vehicle
YES	14	16
NO	4	12

Other pre-specifiedOcular Conjunctival Discharge

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)
Reported as:: Number · participants

Ocular Conjunctival Discharge
participants	Besifloxacin	Vehicle
Visit 1: Absent	0	0
Visit 1: Mild	6	9
Visit 1: Moderate	10	16
Visit 1: Severe	2	3
Visit 2: Absent	9	10
Visit 2: Mild	8	15
Visit 2: Moderate	1	2
Visit 2: Severe	0	0
Visit 3: Absent	14	16
Visit 3: Mild	4	5
Visit 3: Moderate	0	3
Visit 3: Severe	0	0

Other pre-specifiedBulbar Conjunctival Injection

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)
Reported as:: Number · participants

Bulbar Conjunctival Injection
participants	Besifloxacin	Vehicle
Visit 1: Normal	0	0
Visit 1: Mild	3	6
Visit 1: Moderate	14	18
Visit 1: Severe	1	4
Visit 2: Normal	4	7
Visit 2: Mild	13	12
Visit 2: Moderate	1	8
Visit 2: Severe	0	0
Visit 3: Normal	7	12
Visit 3: Mild	11	6
Visit 3: Moderate	0	5
Visit 3: Severe	0	1

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Besifloxacin	—	0/64 (0%)	2/64 (3.1%)
Vehicle	—	0/72 (0%)	3/72 (4.2%)

Most frequent other events

Most frequent other events
Event	Besifloxacin	Vehicle
ConjunctivitisEye disorders	2/64	1/72
Eye PainEye disorders	0/64	2/72

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Besifloxacin	Vehicle	Total
Mean	44.6 ± 22.52	50.6 ± 21.36	47.8 ± 22.03

Sex: Female, Male
Sex: Female, Male(Participants)	Besifloxacin	Vehicle	Total
Female	44	44	88
Male	20	28	48

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Besifloxacin	Vehicle	Total
American Indian or Alaska Native	0	0	0
Asian	4	7	11
Native Hawaiian or Other Pacific Islander	1	1	2
Black or African American	4	7	11
White	51	56	107
More than one race	0	0	0
Unknown or Not Reported	4	1	5

Study locations

1 site

Bausch & Lomb Incorporated
Rochester, New York 14609, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01740388
Lead sponsor: Bausch & Lomb Incorporated
Responsible party: Sponsor
First posted: Dec 4, 2012
Start date: Feb 2013
Primary completion: Jul 2013
Completion: Nov 2013
Results posted: Sep 17, 2014
Last update: Oct 1, 2014

Study contacts

Johnson Varughese

study director · Valeant Pharmaceuticals/Bausch & Lomb Incorporated

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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