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

January 19, 2016 updated by: Deacon Biosciences, Inc.
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Andover Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCN01
Drug: DCN01
Three serial applications per periocular region.
Placebo Comparator: Unisol
Drug: Unisol
Three serial applications per periocular region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in periocular region bacterial load
Time Frame: Baseline to 10 min post dose
Baseline to 10 min post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of periocular regions with a reduction from baseline in bacterial load.
Time Frame: Baseline to 10 min post dose
Baseline to 10 min post dose

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deacon Biosciences, Inc.

Collaborators

ORA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-150-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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