TerminatedNCT01330355Updated Sep 3, 2014Results posted

Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

A Phase 3 interventional study of Besivance and Gatifloxacin in Bacterial Conjunctivitis, sponsored by Bausch & Lomb Incorporated. Terminated at 1 site in United States. Open to participants aged 1 Day to 31 Days. Per ClinicalTrials.gov, last updated 2014-09-03.

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

Why this study was terminated

Lack of enrollment

Phase: Phase 3
Study type: Interventional
Enrollment: 33
Allocation: Randomized
Ages: 1 Day to 31 Days
Sex: All

Study summary

The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).

Conditions studied

Bacterial Conjunctivitis

Browse trials for

Conjunctivitis, Bacterial 40

Keywords

Ocular infections, bacterial

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 33 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.

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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..

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

Who can participate

Ages eligible: 1 Day to 31 Days
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

Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.

Exclusion criteria

Exclusion Criteria:

Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye.
Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible.
Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
Subjects with systemic disease/disorder specified in the protocol as ineligible.
Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components.
Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Care provider, Investigator)
Enrollment: 33 participants (actual)

Study arms

Experimental
Besivance
Besifloxacin 0.6% ophthalmic suspension
Drug: Besivance
Active comparator
Gatifloxacin
Gatifloxacin 0.3% ophthalmic solution
Drug: Gatifloxacin

Interventions

DrugBesivance
Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
DrugGatifloxacin
Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

What researchers measure

Primary outcomes

Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time frame: Visit 5 (Day 8+1)

Secondary outcomes

Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time frame: Visit 3 (Day 3)
Microbial Eradication
Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline
Time frame: Visit 5 (Day 8+1)
Microbial Outcome
Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline: * over all bacterial species * over all and individual gram-positive bacterial species * over all and individual gram-negative bacterial species
Time frame: Visit 3 (Day 3) and Visit 5 (Day 8+1)

Results

Posted Sep 3, 2014

Participant flow

Participant flow — Overall Study
Milestone	Besivance	Gatifloxacin
Started	16	17
Completed	16	17
Not completed	0	0

Outcome measures

PrimaryClinical Resolution

Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.

Time frame:: Visit 5 (Day 8+1)
Reported as:: Number · participants

Clinical Resolution
participants	Besivance	Gatifloxacin
Clinical Resolution	12	12

SecondaryClinical Resolution

Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.

Time frame:: Visit 3 (Day 3)
Reported as:: Number · participants

Clinical Resolution
participants	Besivance	Gatifloxacin
Clinical Resolution	3	5

SecondaryMicrobial Eradication

Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline

Time frame:: Visit 5 (Day 8+1)
Reported as:: Number · participants

Microbial Eradication
participants	Besivance	Gatifloxacin
Microbial Eradication	12	8

SecondaryMicrobial Outcome

Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline: * over all bacterial species * over all and individual gram-positive bacterial species * over all and individual gram-negative bacterial species

Time frame:: Visit 3 (Day 3) and Visit 5 (Day 8+1)
Reported as:: Number · events

Microbial Outcome
events	Besivance	Gatifloxacin
Visit 3 (Day 3) Gram-Positive	16	6
Visit 3 (Day 3) Gram-Negative	6	3
Visit 5 (Day 8) Gram-Positive	17	12
Visit 5 (Day8) Gram-Negative	6	4

Adverse events

Collected over The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Besivance	—	0/16 (0%)	0/16 (0%)
Gatifloxacin	—	0/17 (0%)	5/17 (29.4%)

Most frequent other events

Most frequent other events
Event	Besivance	Gatifloxacin
Conjunctivitis BacterialEye disorders	0/16	1/17
Abdominal PainGastrointestinal disorders	0/16	1/17
IrritabilityPsychiatric disorders	0/16	1/17
RhinorrhoeaRespiratory, thoracic and mediastinal disorders	0/16	1/17
Acne InfantileSkin and subcutaneous tissue disorders	0/16	1/17
DermatitisSkin and subcutaneous tissue disorders	0/16	1/17

Baseline characteristics

Age, Continuous
Age, Continuous(days)	Besivance	Gatifloxacin	Total
Median	17 (6 to 26)	14 (5 to 25)	14 (5 to 26)

Sex: Female, Male
Sex: Female, Male(Participants)	Besivance	Gatifloxacin	Total
Female	12	7	19
Male	4	10	14

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Besivance	Gatifloxacin	Total
American Indian or Alaska Native	0	0	0
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	12	12	24
More than one race	0	0	0
Unknown or Not Reported	3	3	6

Study locations

1 site

Bausch & Lomb Incorporated
Bridgewater, New Jersey 08807, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Jan 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2014, 1 year 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 5, 2011
First posted: Apr 6, 2011
Start: May 2011
Primary completionActual: Jan 2013
CompletionActual: Oct 2013
Results first posted: Sep 3, 2014
Last update: Sep 3, 2014

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01330355
Lead sponsor: Bausch & Lomb Incorporated
Responsible party: Sponsor
First posted: Apr 6, 2011
Start date: May 2011
Primary completion: Jan 2013
Completion: Oct 2013
Results posted: Sep 3, 2014
Last update: Sep 3, 2014

Study contacts

Johnson Varughese

study director · Valeant/Bausch & Lomb

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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