Back to resultsA 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
Primary Purpose
Ocular Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DCN01
Unisol
Sponsored by
About this trial
This is an interventional prevention trial for Ocular Infection focused on measuring DCN01, Ocular Surgical Preparation, Prophylaxis against infection, Pre-operative prep
Eligibility Criteria
Inclusion Criteria:
- Have given a written, informed consent
- Be willing and able to follow all instructions
- A negative urine pregnancy test if female of childbearing potential
Exclusion Criteria:
- 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
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DCN01
Unisol
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in periocular region bacterial load
Secondary Outcome Measures
Proportion of periocular regions with a reduction from baseline in bacterial load.
Full Information
NCT ID
NCT01853722
First Posted
May 8, 2013
Last Updated
January 19, 2016
Sponsor
Deacon Biosciences, Inc.
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01853722
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deacon Biosciences, Inc.
Collaborators
ORA, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Infection
Keywords
DCN01, Ocular Surgical Preparation, Prophylaxis against infection, Pre-operative prep
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCN01
Arm Type
Experimental
Arm Title
Unisol
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DCN01
Intervention Description
Three serial applications per periocular region.
Intervention Type
Drug
Intervention Name(s)
Unisol
Intervention Description
Three serial applications per periocular region.
Primary Outcome Measure Information:
Title
Change from baseline in periocular region bacterial load
Time Frame
Baseline to 10 min post dose
Secondary Outcome Measure Information:
Title
Proportion of periocular regions with a reduction from baseline in bacterial load.
Time Frame
Baseline to 10 min post dose
Other Pre-specified Outcome Measures:
Title
Adverse Events (reported, elicited, observed)
Time Frame
Post dose and up to 2 weeks after (Day 1-14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have given a written, informed consent
Be willing and able to follow all instructions
A negative urine pregnancy test if female of childbearing potential
Exclusion Criteria:
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
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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