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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

NCT01853722 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2016-02-11

No results posted yet for this study

Summary

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

Conditions

  • Ocular Infection

Interventions

DRUG

DCN01

Three serial applications per periocular region.

DRUG

Unisol

Three serial applications per periocular region.

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Deacon Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01853722 on ClinicalTrials.gov