Ocular InfectionPhase 2NCT01853722
A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers
A Phase 2 study testing DCN01 and Unisol in people with Ocular Infection, run by Deacon Biosciences, Inc. at 1 site in United States.
Trial summary
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Infection
- What is being tested?
- DCN01 and Unisol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have given a written, informed consent
- Be willing and able to follow all instructions
- A negative urine pregnancy test if female of childbearing potential
Who cannot join
- Known sensitivities to study medication or its components
- Any signs of an active infection
- Use of disallowed products during the period indicated prior to the enrollment or during the study
- Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
- Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
- Conditions
- Ocular Infection
- Being tested
- DCN01, Unisol
- Keywords
- DCN01, Ocular Surgical Preparation, Prophylaxis against infection, Pre-operative prep
- Medical subject headings
- Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCN01Drug
Three serial applications per periocular region.
UnisolDrug
Three serial applications per periocular region.
| Study group | Role | What they receive |
|---|---|---|
| DCN01 | Experimental | Not described Receives: Drug: DCN01 |
| Unisol | Placebo comparator | Not described Receives: Drug: Unisol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in periocular region bacterial load
Measured: Baseline to 10 min post dose
Secondary outcomes (1)
Proportion of periocular regions with a reduction from baseline in bacterial load.
Measured: Baseline to 10 min post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deacon Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853722
- Sponsor's protocol ID
- 13-150-0002
- Status last verified
- Jan 2016
- First submitted
- 8 May 2013
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01853722
- Acronym / sponsor ID
- 13-150-0002
- Conditions
- Ocular Infection
- Keywords
- DCN01, Ocular Surgical Preparation, Prophylaxis against infection, Pre-operative prep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Deacon Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 May 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.
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCN01 | Experimental | Drug: DCN01 |
| Unisol | Placebo comparator | Drug: Unisol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have given a written, informed consent
- Be willing and able to follow all instructions
- A negative urine pregnancy test if female of childbearing potential
Key exclusion criteria (5 listed)
- Known sensitivities to study medication or its components
- Any signs of an active infection
- Use of disallowed products during the period indicated prior to the enrollment or during the study
- Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
- Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
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 |
|---|---|---|
| DCN01Three serial applications per periocular region. | Drug | DCN01 |
| UnisolThree serial applications per periocular region. | Drug | Unisol |
Primary outcome
Change from baseline in periocular region bacterial load
Time frame: Baseline to 10 min post dose
1 secondary outcome
Proportion of periocular regions with a reduction from baseline in bacterial load.
Time frame: Baseline to 10 min post dose
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 11 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DCN01 and Unisol in people with Ocular Infection, run by Deacon Biosciences, Inc. 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 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 11 Feb 2016. 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 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?
Change from baseline in periocular region bacterial load (time frame: Baseline to 10 min post dose). 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 11 Feb 2016.