Trial record 6 of 38 for:    Open Studies | "Eye Infections"

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 is currently recruiting participants.
Verified May 2013 by Deacon Biosciences, Inc.
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Deacon Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01853722
First received: May 8, 2013
Last updated: May 9, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of periocular regions with a reduction from baseline in bacterial load. [ Time Frame: Baseline to 10 min post dose ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 250
Study Start Date: April 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01853722

Contacts
Contact: Sunita Saigal 978-685-8900

Locations
United States, Massachusetts
Andover Eye Associates Recruiting
Andover, Massachusetts, United States, 01810
Principal Investigator: Gail L Torkildsen, MD         
Sponsors and Collaborators
Deacon Biosciences, Inc.
ORA, Inc.
  More Information

No publications provided

Responsible Party: Deacon Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01853722     History of Changes
Other Study ID Numbers: 13-150-0002
Study First Received: May 8, 2013
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014