Trial | NCT01853722  Report issue

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dcn01 ...

  • Study Participants

    62
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
Study Started
Apr 30
2013
Primary Completion
Jul 31
2013
Study Completion
Jul 31
2013
Last Update
Feb 11
2016
Estimate

Drug DCN01

Three serial applications per periocular region.

Drug Unisol

Three serial applications per periocular region.

DCN01 Experimental

Unisol Placebo Comparator

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
No Results Posted