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
- Registration Number
- NCT01853722
- Lead Sponsor
- Deacon Biosciences, Inc.
- Brief Summary
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DCN01 DCN01 - Unisol Unisol -
- Primary Outcome Measures
Name Time Method Change from baseline in periocular region bacterial load Baseline to 10 min post dose
- Secondary Outcome Measures
Name Time Method Proportion of periocular regions with a reduction from baseline in bacterial load. Baseline to 10 min post dose
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States