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OCT- clear

Phase 2

Preoperative Skin Preparation | Small molecule | Dermatology |Becton, Dickinson and Company|Trials Updated: Apr 23, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment131

FDA Designations

No designations recorded

OCT- clear clinical trials

OCT- clear · 1 trial · 1 indication

Phase 2 1
NCT03224299Effectiveness of an Antimicrobial Agent for Preoperative Skin PreparationPreoperative Skin Preparation
COMPLETED131 Analytics
PHASE2COMPLETED
Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation
Preoperative Skin PreparationUnlock trial analytics

Study Endpoints

Primary Endpoints

Antimicrobial Activity of the Investigational Products Compared to Control.
10 minutes

Secondary Endpoints

Responder Rate at 6 Hours Post-application
6 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Investigational Product #1 (IP1)EXPERIMENTALoctenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
Investigational Product #2 (IP2)EXPERIMENTALoctenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
Active ControlACTIVE_COMPARATORChloraPrep® - Hi-Lite Orange® applicator
Negative ControlPLACEBO_COMPARATORsterile 0.9% saline applied with single use applicator

Interventions

NameTypeDescription
OCT - clearDRUGInvestigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
OCT- tintedDRUGInvestigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
ChloraPrepOTHERActive Control: ChloraPrep® - Hi-Lite Orange® applicator
SalineOTHERNegative Control: sterile 0.9% saline applied with single use applicator
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Subjects may be of either sex, at least 18 years of age and of any race. * Subjects must be in good general health. * Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and the List of Restricted Products ...

Countries:United States
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Frequently asked questions about OCT- clear

What is OCT-clear?

OCT-clear is an investigational small molecule developed by Becton, Dickinson and Company for preoperative skin preparation. It is designed as an antimicrobial agent applied to the skin before surgery. It has completed a Phase 2 clinical trial and is not yet approved for commercial use.

What is OCT-clear used for?

OCT-clear is being studied for preoperative skin preparation, meaning it is intended to reduce microorganisms on the skin before a surgical procedure. Its only recorded clinical trial enrolled healthy adult volunteers aged 18 and older in the United States, evaluating its effectiveness as an antimicrobial skin preparation agent.

Who makes OCT-clear?

OCT-clear is developed by Becton, Dickinson and Company, which trades under the ticker BDX. The company sponsored the Phase 2 study of the agent for preoperative skin preparation. No partnership or licensing arrangement for OCT-clear is disclosed.

What phase is OCT-clear in?

OCT-clear has completed a Phase 2 clinical trial and remains investigational. It is not approved by the FDA for preoperative skin preparation. The Phase 2 study has been completed, and no active trials are currently listed for this asset.

What clinical trials is OCT-clear in?

OCT-clear has been evaluated in one completed Phase 2 trial, NCT03224299, titled Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation. The study enrolled 131 healthy adult volunteers in the United States, was randomized, double-blind, and placebo-controlled, and has finished.

Is OCT-clear the same as OCT - clear?

Yes, OCT-clear and OCT - clear refer to the same investigational product from Becton, Dickinson and Company. The spacing and hyphenation vary between sources, but both names describe the same antimicrobial agent studied for preoperative skin preparation in the completed Phase 2 trial NCT03224299.