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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01853722
First Posted: May 15, 2013
Last Update Posted: February 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Deacon Biosciences, Inc.
  Purpose
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.

Condition Intervention Phase
Ocular Infection Drug: DCN01 Drug: Unisol Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Deacon Biosciences, Inc.:

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

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

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

Enrollment: 62
Study Start Date: April 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCN01 Drug: DCN01
Three serial applications per periocular region.
Placebo Comparator: Unisol Drug: Unisol
Three serial applications per periocular region.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Deacon Biosciences, Inc.
ORA, Inc.
  More Information

Responsible Party: Deacon Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01853722     History of Changes
Other Study ID Numbers: 13-150-0002
First Submitted: May 8, 2013
First Posted: May 15, 2013
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:
Eye Infections
Infection
Eye Diseases
Anti-Infective Agents
Anti-Bacterial Agents