NCT01853722

CompletedPhase 2

A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-C...

Deacon Biosciences, Inc.Source

Compare

Other study identifiers

Sponsor study identifier

13-150-0002

Study Type

interventional

Actual enrollment (reported)

62

Locations

1 country

Sites

1

Timeline

Study Start

April 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2013

Actual (reported)

Study Completion

July 2013

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 62 participants
Study completion date: July 2013
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 8, 2013
Actual (reported)
First Posted
May 15, 2013
Actual (reported)
Primary Completion
July 2013
Actual (reported)
Study Completion
July 2013
Actual (reported)

Last Updated: February 11, 2016
Status Verified: January 2016
Last Update Submitted: January 19, 2016

Conditions

Ocular Infection

Keywords

DCN01Ocular Surgical PreparationProphylaxis against infectionPre-operative prep

Outcome Measures

Primary Outcomes (1)

Change from baseline in periocular region bacterial load
Baseline to 10 min post dose

Secondary Outcomes (1)

Proportion of periocular regions with a reduction from baseline in bacterial load.
Baseline to 10 min post dose

Other Outcomes (1)

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

Study Arms (2)

DCN01

EXPERIMENTAL

Drug: DCN01

Unisol

PLACEBO COMPARATOR

Drug: Unisol

Interventions

DCN01Drug

Three serial applications per periocular region.

DCN01

UnisolDrug

Three serial applications per periocular region.

Unisol

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have given a written, informed consent
Be willing and able to follow all instructions

Sponsors & Collaborators

Deacon Biosciences, Inc.
Industrylead
ORA, Inc.
Industrycollaborator

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

MeSH Terms

Conditions

Eye Infections

Interventions

UHK solution

Condition Hierarchy (Ancestors)

InfectionsEye Diseases

Enrollment

62 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 15, 2013

Study Start

April 2013

Date type not reported

This date has not been verified as actual or estimated.

NCT00335088

Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations

Phase 3Unknown

NCT04087733

Effectiveness of Liposomial Ozonized-Oil for Cataract Surgery

Phase 4Completed

NCT00575367

Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

Phase 4Completed

NCT00198523

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Phase 3Completed

NCT00347828

Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose

Phase 4Unknown

NCT00564447

Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

Phase 4Completed

A negative urine pregnancy test if female of childbearing potential

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

July 2013

Actual (reported)

Study Completion

July 2013

Actual (reported)

Last Updated

February 11, 2016

Record last verified: 2016-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01853722
Data provider: ClinicalTrials.gov
Source updated: 2016-02-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:25 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

DCN01

Unisol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations