Adenoviral ConjunctivitisPhase 2BAYnovation™NCT01532336
Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis
A Phase 2 study testing NVC-422 Solution, 0.3% in people with Adenoviral Conjunctivitis, run by NovaBay Pharmaceuticals, Inc. at 58 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the clinical and microbiological efficacy and safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Adenoviral Conjunctivitis
- What is being tested?
- NVC-422 Solution, 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 58 sitesin 4 countries
- Study dates
- May 2012to Aug 2014
- 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
- Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less
- Bulbar conjunctival injection
- Other inclusion criteria per protocol
Who cannot join
- Presence of subepithelial infiltrates (SEIs) at the Day 1 visit in either eye
- A suspected bacterial, fungal, herpes, Chlamydia or Acanthamoeba co-infection, based on clinical observation
- Other exclusion criteria per protocol
Trial locations and contacts
58 sites in 4 countries.
58 sites in 4 countries
United States24 sites
Study site
Albany, Georgia, 31701
Study site
Asheville, North Carolina, 28803
Study site
Charleston, South Carolina, 29414
Study site
Fort Myers, Florida, 33901
Study site
Glendale, California, 91205
Study site
Glenview, Illinois, 60026
Study site
Hazard, Kentucky, 41701
Study site
Hicksville, New York, 11801
Study site
High Point, North Carolina, 27262
Study site
Jacksonville Beach, Florida, 32250
Study site
Kailua, Hawaii, 96734
Study site
Kansas City, Missouri, 64154
Study site
Los Angeles, California, 90048
Study site
Peoria, Illinois, 61615
Study site
Petaluma, California, 94954
Study site
Pittsburgh, Pennsylvania, 15206
Study site
Rockville Centre, New York, 11570
Study site
San Diego, California, 92115
Study site
Shawnee Mission, Kansas, 66204
Study site
Spartanburg, South Carolina, 29306
Study site
St Louis, Missouri, 63131
Study site
Tampa, Florida, 33603
Study site
Winchester, Massachusetts, 01890
Study site
Winston-Salem, North Carolina, 27101
India20 sites
Study site
Ahmedabad, Gujarat, 380 016
Study site
Bangalore, Karnataka, 560 010
Study site
Bangalore, Karnataka, 560 054
Study site
Bikaner, Rajasthan, 334 001
Study site
Chennai, Tamil Nadu, 600 010
Study site
Daryāganj, New Dehli, 110 002
Study site
Hyderabad, Andhra Pradesh, 500 034
Study site
Hyderabad, Andhra Pradesh, 500 096
Study site
Jaipur, Rajasthan, 302 004
Study site
Jaipur, Rajasthan, 302 015
Study site
Kolkata, West Bengal, 700 073
Study site
Mumbai, Maharashtra, 400 004
Study site
Mumbai, Maharashtra, 400 020
Study site
Mumbai, Maharashtra, 400 080
Study site
Mumbai, Maharashtra, 400 602
Study site
New Dehli, New Dehli, 110 608
Study site
Salem, Tamil Nadu, 636 004
Study site
Surat, Gujarat, 395 001
Study site
Thiruvanathapuram, Kerala, 695 011
Study site
Visakhapatnam, Vishakhapatnam, 530 013
Brazil8 sites
Study site
Joinville, Santa Catarina, 89201-010
Study site
Porto Alegre, Rio Grande do Sul, 90035-903
Study site
Recife, Pernambuco, 50070-040
Study site
Rio de Janeiro, Rio de Janeiro, 21941-913
Study site
São Paulo, São Paulo, 01221-020
Study site
São Paulo, São Paulo, 04023-062
Study site
São Paulo, São Paulo, 04502-001
Study site
Sorocaba, São Paulo, 18031-060
Sri Lanka6 sites
Study site
Colombo, 01000
Study site
Colombo, 11010
Study site
Colombo
Study site
Kalubowila, 10350
Study site
Negombo, 11500
Study site
Nugegoda, 10250
About this study
Official title: A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
The purpose of this study is to evaluate the clinical and microbiological efficacy and safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening, Inc).
Subjects will be randomly assigned to receive either NVC-422 or Vehicle.
Read the detailed description
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: NVC-422 Ophthalmic Solution 0.33% ("NVC-422") and NVC-422 Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 6 visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 3
- Visit 3: Day 6
- Visit 4: Day 11 End of Treatment (EOT)
- Visit 5: Day 18 Test-of-Cure (TOC)
- Visit 6: Day 42 Follow-up
Subjects were dosed OU for 10 days. Specimens were collected OU at each visit for quantitative PCR adenoviral load and molecular typing.
- Conditions
- Adenoviral Conjunctivitis
- Being tested
- NVC-422 Solution, 0.3%, NVC-422 Vehicle Solution
- Keywords
- adenovirus, conjunctivitis, pinkeye
- Medical subject headings
- Adenoviridae Infections, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVC-422 Solution, 0.3%Drug
Also called Auriclosene
NVC-422 Ophthalmic Solution dropped onto the eye
NVC-422 Vehicle SolutionDrug
NVC-422 Vehicle Ophthalmic Solution dropped onto the eye
| Study group | Role | What they receive |
|---|---|---|
| NVC-422 Solution, 0.3% | Experimental | Dosed for 10 days Receives: Drug: NVC-422 Solution, 0.3% |
| NVC-422 Vehicle Solution | Placebo comparator | Dosed for 10 days Receives: Drug: NVC-422 Vehicle Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Clinical Cure
Measured: Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoviral 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Stroman, Ph.D., Study director, NovaBay Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532336
- Sponsor's protocol ID
- CL1104
- Other IDs
- BAYnovation
- Acronym
- BAYnovation™
- Status last verified
- Jul 2014
- First submitted
- 9 Feb 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
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 NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
- ClinicalTrials.gov ID
- NCT01532336
- Acronym / sponsor ID
- BAYnovation™ / CL1104
- Conditions
- Adenoviral Conjunctivitis
- Keywords
- adenovirus, conjunctivitis, pinkeye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Feb 2012 (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 clinical and microbiological efficacy and safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening, Inc).
Subjects will be randomly assigned to receive either NVC-422 or Vehicle.
Detailed description
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: NVC-422 Ophthalmic Solution 0.33% ("NVC-422") and NVC-422 Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 6 visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 3
- Visit 3: Day 6
- Visit 4: Day 11 End of Treatment (EOT)
- Visit 5: Day 18 Test-of-Cure (TOC)
- Visit 6: Day 42 Follow-up
Subjects were dosed OU for 10 days. Specimens were collected OU at each visit for quantitative PCR adenoviral load and molecular typing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVC-422 Solution, 0.3% | Experimental | Drug: NVC-422 Solution, 0.3%Dosed for 10 days |
| NVC-422 Vehicle Solution | Placebo comparator | Drug: NVC-422 Vehicle SolutionDosed for 10 days |
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)
- Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less
- Bulbar conjunctival injection
- Other inclusion criteria per protocol
Key exclusion criteria (3 listed)
- Presence of subepithelial infiltrates (SEIs) at the Day 1 visit in either eye
- A suspected bacterial, fungal, herpes, Chlamydia or Acanthamoeba co-infection, based on clinical observation
- 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 |
|---|---|---|
| NVC-422 Solution, 0.3%Also: AuricloseneNVC-422 Ophthalmic Solution dropped onto the eye | Drug | NVC-422 Solution, 0.3% |
| NVC-422 Vehicle SolutionNVC-422 Vehicle Ophthalmic Solution dropped onto the eye | Drug | NVC-422 Vehicle Solution |
Primary outcome
Sustained Clinical Cure
Time frame: Day 18
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.
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 Stroman, Ph.D. study director
NovaBay Pharmaceuticals, Inc.
58 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NVC-422 Solution, 0.3% in people with Adenoviral Conjunctivitis, run by NovaBay Pharmaceuticals, Inc. at 58 sites in 4 countries.
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 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 58 sites in United States, India, Brazil, Sri Lanka. 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?
Sustained Clinical Cure (time frame: Day 18). 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 28 May 2015.