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OpenTrials
Completed

NCT Number: NCT01853722

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 proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.

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Key information

Conditions

Ocular Infection Eye Diseases Eye Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DCN01

Drug

Three serial applications per periocular region.

Unisol

Drug

Three serial applications per periocular region.

Primary outcomes

  1. Change from baseline in periocular region bacterial load

    Time frame: Baseline to 10 min post dose

Secondary outcomes

  1. Proportion of periocular regions with a reduction from baseline in bacterial load.

    Time frame: Baseline to 10 min post dose

Other outcomes

  1. Adverse Events (reported, elicited, observed)

    Time frame: Post dose and up to 2 weeks after (Day 1-14)

Sponsors and collaborators

Lead sponsor

Deacon Biosciences, Inc.

Industry

Collaborators

  • ORA, Inc.

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 15, 2013
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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