Bacterial ConjunctivitisPhase 2BACTOvation™NCT01877694
Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis
A Phase 2 study testing Auriclosene Solution 0.3% in people with Bacterial Conjunctivitis, run by NovaBay Pharmaceuticals, Inc. at 21 sites in United States.
Trial summary
The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. 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?
- Auriclosene Solution 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2013to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 1 year of age and older
- Bulbar conjunctival injection
- Conjunctival discharge/exudate
- Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less
- Other inclusion criteria per protocol
Who cannot join
- Suspected fungal, viral, Chlamydia or Acanthamoeba co-infection based on clinical diagnosis
- Any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment
- Other exclusion criteria per protocol
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Anaheim, California, 92804
Study site
Bellflower, California, 90706
Study site
Birmingham, Alabama, 35244
Study site
Charlottesville, Virginia, 22902
Study site
Cincinnati, Ohio, 45246
Study site
Clearwater, Florida, 33761
Study site
Clinton, Utah, 84015
Study site
Corsicana, Texas, 75110
Study site
Dayton, Ohio, 45432
Study site
Evansville, Indiana, 47714
Study site
Glendale, California, 91204
Study site
Huntersville, North Carolina, 28078
Study site
Huntington Beach, California, 92647
Study site
Midlothian, Virginia, 23113
Study site
Newton, Kansas, 67114
Study site
Phoenix, Arizona, 85032
Study site
San Antonio, Texas, 78215
Study site
Spokane, Washington, 99202
Study site
Whitehouse Station, New Jersey, 08889
Study site
Winston-Salem, North Carolina, 27101
Study site
Woodstock, Georgia, 30189
About this study
Official title: A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis
The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.
Read the detailed description
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: Auriclosene Ophthalmic Solution 0.3% ("Auriclosene") and Auriclosene Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 3 (±1)
- Visit 3: Day 5 (+1) Test of Cure/Exit
IP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected from each eye at each visit.
Visual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.
- Conditions
- Bacterial Conjunctivitis
- Being tested
- Auriclosene Solution 0.3%, Auriclosene Vehicle
- Keywords
- pink eye
- Medical subject headings
- Conjunctivitis, Bacterial, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auriclosene Solution 0.3%Drug
Also called NVC-422
Ophthalmic solution dispensed as drops onto the eye
Auriclosene VehicleDrug
Ophthalmic Vehicle solution dispensed as drops onto the eye
| Study group | Role | What they receive |
|---|---|---|
| Auriclosene Solution 0.3% | Experimental | Dosed QID for 4 Days Receives: Drug: Auriclosene Solution 0.3% |
| Auriclosene Vehicle | Placebo comparator | Dosed QID for 4 days Receives: Drug: Auriclosene Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological Success
Eradication of all pre-therapy isolates
Measured: 5 days
Secondary outcomes (1)
Clinical Cure
Resolution of all signs and symptoms
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David W. Stroman, Ph.D., Study director, NovaBay Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877694
- Sponsor's protocol ID
- CL1301
- Acronym
- BACTOvation™
- Status last verified
- May 2015
- First submitted
- 7 Jun 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee CS, Lee AY, Akileswaran L, Stroman D, Najafi-Tagol K, Kleiboeker S, Chodosh J, Magaret A, Wald A, Van Gelder RN; BAYnovation Study Group. Determinants of Outcomes of Adenoviral Keratoconjunctivitis. Ophthalmology. 2018 Sep;125(9):1344-1353. doi: 10.1016/j.ophtha.2018.02.016. Epub 2018 Mar 27.
PubMed 29602567
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis
- ClinicalTrials.gov ID
- NCT01877694
- Acronym / sponsor ID
- BACTOvation™ / CL1301
- Conditions
- Bacterial Conjunctivitis
- Keywords
- pink eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.
Detailed description
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: Auriclosene Ophthalmic Solution 0.3% ("Auriclosene") and Auriclosene Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 3 (±1)
- Visit 3: Day 5 (+1) Test of Cure/Exit
IP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected from each eye at each visit.
Visual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auriclosene Solution 0.3% | Experimental | Drug: Auriclosene Solution 0.3%Dosed QID for 4 Days |
| Auriclosene Vehicle | Placebo comparator | Drug: Auriclosene VehicleDosed QID for 4 days |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1 year of age and older
- Bulbar conjunctival injection
- Conjunctival discharge/exudate
- Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less
- Other inclusion criteria per protocol
Key exclusion criteria (3 listed)
- Suspected fungal, viral, Chlamydia or Acanthamoeba co-infection based on clinical diagnosis
- Any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment
- Other exclusion criteria per protocol
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 |
|---|---|---|
| Auriclosene Solution 0.3%Also: NVC-422Ophthalmic solution dispensed as drops onto the eye | Drug | Auriclosene Solution 0.3% |
| Auriclosene VehicleOphthalmic Vehicle solution dispensed as drops onto the eye | Drug | Auriclosene Vehicle |
Primary outcome
Microbiological Success
Time frame: 5 days
Eradication of all pre-therapy isolates
1 secondary outcome
Clinical Cure
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 29602567Lee CS, Lee AY, Akileswaran L, Stroman D, Najafi-Tagol K, Kleiboeker S, Chodosh J, Magaret A, Wald A, Van Gelder RN; BAYnovation Study Group. Determinants of Outcomes of Adenoviral Keratoconjunctivitis. Ophthalmology. 2018 Sep;125(9):1344-1353. doi: 10.1016/j.ophtha.2018.02.016. Epub 2018 Mar 27.
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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.
David W. Stroman, Ph.D. study director
NovaBay Pharmaceuticals, Inc.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Auriclosene Solution 0.3% in people with Bacterial Conjunctivitis, run by NovaBay Pharmaceuticals, Inc. at 21 sites 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 5 inclusion and 3 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microbiological Success (time frame: 5 days). 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 NCT01877694, which also lists 1 linked publication.
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 28 May 2015.