Acute Bacterial ConjunctivitisPhase 3NCT00347932
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
A Phase 3 study testing ISV-403 in people with Acute Bacterial Conjunctivitis, run by Bausch & Lomb Incorporated.
Trial summary
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Bacterial Conjunctivitis
- What is being tested?
- ISV-403
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 957 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Nov 2007
- 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
- Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
- Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.
Who cannot join
- Pregnant or nursing females.
- Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
- Use of any antibiotic within 72 hours of treatment.
- Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
- Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
About this study
Official title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
- Conditions
- Acute Bacterial Conjunctivitis
- Being tested
- ISV-403, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISV-403Drug
Also called besifloxacin, Besivance, BOL-303224
Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.
VehicleDrug
Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| ISV-403 | Experimental | 0.6% ISV-403 ophthalmic suspension Receives: Drug: ISV-403 |
| Vehicle | Placebo comparator | Vehicle of ISV-403 ophthalmic suspension Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Resolution of Baseline Bacterial Conjunctivitis
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Measured: Day 5 +/- 1 day
Microbial Eradication of Baseline Bacterial Infection
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Measured: Day 5 +/- 1 day
Secondary outcomes (2)
Clinical Resolution of Baseline Bacterial Conjunctivitis
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Measured: Day 8 or 9
Microbial Eradication of Baseline Bacterial Infection
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Measured: Day 8 or 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionNov 2007
- Study completionNov 2007
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Trusso, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347932
- Sponsor's protocol ID
- 433
- Other IDs
- BOL-303224
- Status last verified
- Mar 2015
- First submitted
- 30 Jun 2006
- Last updated
- 24 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.
PubMed 32841261Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.
PubMed 20629472Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009 May;25(5):1159-69. doi: 10.1185/03007990902837919.
PubMed 19323612
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.
- ClinicalTrials.gov ID
- NCT00347932
- Acronym / sponsor ID
- 433
- Conditions
- Acute Bacterial Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 957 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Posted 13 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISV-403 | Experimental | Drug: ISV-4030.6% ISV-403 ophthalmic suspension |
| Vehicle | Placebo comparator | Drug: VehicleVehicle of ISV-403 ophthalmic suspension |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
- Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.
Key exclusion criteria (5 listed)
- Pregnant or nursing females.
- Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
- Use of any antibiotic within 72 hours of treatment.
- Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
- Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
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 |
|---|---|---|
| ISV-403Also: besifloxacin, Besivance, BOL-303224Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days. | Drug | ISV-403 |
| VehicleSubjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days. | Drug | Vehicle |
Primary outcome
Clinical Resolution of Baseline Bacterial Conjunctivitis
Time frame: Day 5 +/- 1 day
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Microbial Eradication of Baseline Bacterial Infection
Time frame: Day 5 +/- 1 day
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
2 secondary outcomes
Clinical Resolution of Baseline Bacterial Conjunctivitis
Time frame: Day 8 or 9
Microbial Eradication of Baseline Bacterial Infection
Time frame: Day 8 or 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32841261DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.
- Derived from this study: PubMed 20629472Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.
- Derived from this study: PubMed 19323612Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009 May;25(5):1159-69. doi: 10.1185/03007990902837919.
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.
Laura Trusso study director
Bausch & Lomb Incorporated
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ISV-403 in people with Acute Bacterial Conjunctivitis, run by Bausch & Lomb Incorporated.
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 2 inclusion and 5 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 13 Aug 2009). 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 of Baseline Bacterial Conjunctivitis (time frame: Day 5 +/- 1 day). 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?
On the ClinicalTrials.gov record for NCT00347932, which also lists 3 linked publications.
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 24 Mar 2015.