Bacterial ConjunctivitisPhase 3NCT01330355
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
A Phase 3 study testing Besivance and Gatifloxacin 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 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). Read more about this study
- Who is it for?
- Ages 1 day to 31 days
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- Besivance and Gatifloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2013
- 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 day to 31 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Bridgewater, New Jersey, 08807
About this study
Official title: Evaluation of the Safety and Efficacy of Topical Besifloxacin Ophthalmic Suspension, 0.6% Compared With Gatifloxacin, 0.3% Ophthalmic Solution for the Treatment of Presumed Bacterial Conjunctivitis in Subjects From Birth to 31 Days of Age
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
- Bacterial Conjunctivitis
- Being tested
- Besivance, Gatifloxacin
- Keywords
- Ocular infections, bacterial
- Medical subject headings
- Conjunctivitis, Bacterial, Eye Infections, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BesivanceDrug
Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
GatifloxacinDrug
Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Besivance | Experimental | Besifloxacin 0.6% ophthalmic suspension Receives: Drug: Besivance |
| Gatifloxacin | Active comparator | Gatifloxacin 0.3% ophthalmic solution Receives: Drug: Gatifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Measured: Visit 5 (Day 8+1)
Secondary outcomes (3)
Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Measured: 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
Measured: 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
Measured: Visit 3 (Day 3) and Visit 5 (Day 8+1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2013
- Study completionOct 2013
Why it stopped: Lack of enrollment
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
- Care provider, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson Varughese, Study director, Valeant/Bausch & Lomb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330355
- Sponsor's protocol ID
- 646
- Status last verified
- Aug 2014
- First submitted
- 5 Apr 2011
- Last updated
- 3 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Topical Besifloxacin Ophthalmic Suspension, 0.6% Compared With Gatifloxacin, 0.3% Ophthalmic Solution for the Treatment of Presumed Bacterial Conjunctivitis in Subjects From Birth to 31 Days of Age
- ClinicalTrials.gov ID
- NCT01330355
- Acronym / sponsor ID
- 646
- Conditions
- Bacterial Conjunctivitis
- Keywords
- Ocular infections, bacterial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Posted 3 Sep 2014
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Besivance | Experimental | Drug: BesivanceBesifloxacin 0.6% ophthalmic suspension |
| Gatifloxacin | Active comparator | Drug: GatifloxacinGatifloxacin 0.3% ophthalmic solution |
Who may qualify
- Ages
- 1 day to 31 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| BesivanceBesifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days | Drug | Besivance |
| GatifloxacinGatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days | Drug | Gatifloxacin |
Primary outcome
Clinical Resolution
Time frame: Visit 5 (Day 8+1)
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
3 secondary outcomes
Clinical Resolution
Time frame: Visit 3 (Day 3)
Microbial Eradication
Time frame: Visit 5 (Day 8+1)
Microbial Outcome
Time frame: Visit 3 (Day 3) and Visit 5 (Day 8+1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- 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.
Johnson Varughese study director
Valeant/Bausch & Lomb
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 and Gatifloxacin 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Sep 2014. 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. 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 3 Sep 2014). 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?
Clinical Resolution (time frame: Visit 5 (Day 8+1)). 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 3 Sep 2014.