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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

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ClinicalTrials.gov Identifier: NCT01853722
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : February 11, 2016
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Deacon Biosciences, Inc.

Study Description
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Brief Summary:
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.

Condition or disease Intervention/treatment Phase
Ocular Infection Drug: DCN01 Drug: Unisol Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : April 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: DCN01 Drug: DCN01
Three serial applications per periocular region.
Placebo Comparator: Unisol Drug: Unisol
Three serial applications per periocular region.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in periocular region bacterial load [ Time Frame: Baseline to 10 min post dose ]

Secondary Outcome Measures :
  1. Proportion of periocular regions with a reduction from baseline in bacterial load. [ Time Frame: Baseline to 10 min post dose ]

Other Outcome Measures:
  1. Adverse Events (reported, elicited, observed) [ Time Frame: Post dose and up to 2 weeks after (Day 1-14) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853722


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Deacon Biosciences, Inc.
ORA, Inc.
More Information
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Responsible Party: Deacon Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01853722    
Other Study ID Numbers: 13-150-0002
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: January 2016
Keywords provided by Deacon Biosciences, Inc.:
DCN01
Ocular Surgical Preparation
Prophylaxis against infection
Pre-operative prep
Additional relevant MeSH terms:
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Eye Infections
Infections
Eye Diseases