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
NCT ID: NCT01853722
Last Updated: 2016-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2013-04-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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DCN01
DCN01
Three serial applications per periocular region.
Unisol
Unisol
Three serial applications per periocular region.
Interventions
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DCN01
Three serial applications per periocular region.
Unisol
Three serial applications per periocular region.
Eligibility Criteria
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Inclusion Criteria
* Be willing and able to follow all instructions
* A negative urine pregnancy test if female of childbearing potential
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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ORA, Inc.
INDUSTRY
Deacon Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Andover Eye Associates
Andover, Massachusetts, United States
Countries
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Other Identifiers
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13-150-0002
Identifier Type: -
Identifier Source: org_study_id
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