Overview
A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to UnisolĀ® Following Topical Periocular Administration in Healthy Volunteers
Status:
Completed
Completed
Trial end date:
2013-07-01
2013-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.Phase:
Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Deacon Biosciences, Inc.Collaborator:
ORA, Inc.Treatments:
Anti-Infective Agents
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