Bacterial ConjunctivitisPhase 3NCT01175590
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
A Phase 3 study testing Besivance in people with Bacterial Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- Besivance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Feb 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
- Conditions
- Bacterial Conjunctivitis
- Being tested
- Besivance, Vehicle
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BesivanceDrug
Ocular administration to affected eye for 7 days
VehicleDrug
Vehicle of Besivance administered to affected eye for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Besivance | Experimental | besifloxacin ophthalmic suspension 0.6% Receives: Drug: Besivance |
| Vehicle | Placebo comparator | Vehicle of Besivance Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Treatment Emergent Adverse Events
Ocular Treatment-Emergent Adverse Events on the Study Eye
Measured: At each visit - 7 days
Non-Ocular Treatment-Emergent Adverse Events
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
Measured: 7 days
Secondary outcomes (12)
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data
Measured: Day 8 (Visit 2)
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
Measured: Day 11 (Visit 3)
Microbial Eradication
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Measured: Days 8 (Visit 2)
Microbial Eradication
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Measured: Days 11 (Visit 3)
Microbial Outcome With Clinical Resolution
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Measured: Day 8 (Visit 2)
Microbial Outcome With Clinical Resolution
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Measured: Day 11 (Visit 3)
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Measured: At day 1 (Vist 1)
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Measured: At day 8 (Vist 2)
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Measured: At day 11 (Vist 3)
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Measured: At day 1 (Vist 1)
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Measured: At day 8 (Vist 2)
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Measured: At day 11 (Vist 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Allaire, MD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175590
- Sponsor's protocol ID
- 631
- Status last verified
- Mar 2013
- First submitted
- 3 Aug 2010
- Last updated
- 1 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01175590
- Acronym / sponsor ID
- 631
- Conditions
- Bacterial Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Posted 1 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Besivance | Experimental | Drug: Besivancebesifloxacin ophthalmic suspension 0.6% |
| Vehicle | Placebo comparator | Drug: VehicleVehicle of Besivance |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BesivanceOcular administration to affected eye for 7 days | Drug | Besivance |
| VehicleVehicle of Besivance administered to affected eye for 7 days | Drug | Vehicle |
Primary outcome
Ocular Treatment Emergent Adverse Events
Time frame: At each visit - 7 days
Ocular Treatment-Emergent Adverse Events on the Study Eye
Non-Ocular Treatment-Emergent Adverse Events
Time frame: 7 days
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
12 secondary outcomes
Clinical Resolution
Time frame: Day 8 (Visit 2)
Clinical Resolution
Time frame: Day 11 (Visit 3)
Microbial Eradication
Time frame: Days 8 (Visit 2)
Microbial Eradication
Time frame: Days 11 (Visit 3)
Microbial Outcome With Clinical Resolution
Time frame: Day 8 (Visit 2)
Microbial Outcome With Clinical Resolution
Time frame: Day 11 (Visit 3)
Individual Clinical Outcomes - Ocular Discharge
Time frame: At day 1 (Vist 1)
Individual Clinical Outcomes - Ocular Discharge
Time frame: At day 8 (Vist 2)
Individual Clinical Outcomes - Ocular Discharge
Time frame: At day 11 (Vist 3)
Individual Clinical Outcomes - Bulbar Injection
Time frame: At day 1 (Vist 1)
Individual Clinical Outcomes - Bulbar Injection
Time frame: At day 8 (Vist 2)
Individual Clinical Outcomes - Bulbar Injection
Time frame: At day 11 (Vist 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Allaire, MD study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Besivance in people with Bacterial Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Treatment Emergent Adverse Events (time frame: At each visit - 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2013.