Status:
COMPLETED
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
Lead Sponsor:
Deacon Biosciences, Inc.
Collaborating Sponsors:
ORA, Inc.
Conditions:
Ocular Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01853722
Start Date
April 1 2013
End Date
July 1 2013
Last Update
February 11 2016
Active Locations (1)
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1
Andover Eye Associates
Andover, Massachusetts, United States, 01810