A Human Factors Study to Evaluate a Novel Intracanalicula... | NCT04945824

Studies
A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects

NCT04945824

Sponsor

Ocular Therapeutix, Inc.

Status

Terminated

Last Update Posted

Feb 6, 2023Actual

Enrollment

2Actual

Phase

Early Phase 1

Conditions

Healthy

Interventions

Dexamethasone Ophthalmic
Dilator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inserter device did not perform as expected

Expanded Access Info

Not provided

Start Date

Jun 1, 2021Actual

Primary Completion Date

Nov 1, 2022Actual

Completion Date

Nov 1, 2022Actual

First Submitted Date

Jun 1, 2021

First Submission Date that Met QC Criteria

Jun 22, 2021

First Posted Date

Jun 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2023

Last Update Posted Date

Feb 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Each subject's participation is expected to last for approximately 1 month from the DEXTENZA insertion.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Novel Intracanalicular Insertion Device	Experimental		Drug: Dexamethasone Ophthalmic Device: Dilator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone Ophthalmic	Drug	Insertion Device: A handheld mechanical device used by the clinician to dilate the punctum and deliver the DEXTENZA insert into the canaliculus; designed to be single-use and pre-loaded with a single DEXTENZA insert.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ease of insertion as assessed by Post-Insertion Investigator Questionnaire		Assessed at Visit 1 (Day 1)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are a healthy adult subject aged 18 years or older with no known significant health problems
Are willing to refrain from wearing contact lens for the duration of the study
Are willing and able to comply with clinic visits and study related procedures
Are willing and able to sign the informed consent form

Exclusion Criteria:

Have known significant health problems
Are women of reproductive potential
Are breastfeeding
Are a known steroid responder
Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
Have a history of complete punctal occlusion in one or both punctum
Currently use topical ophthalmic steroid medications
Are unwilling or unable to comply with the study protocol
Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ocular Therapeutix, Inc.		Sioux Falls	South Dakota	57108	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jan 10, 2024
Reset	Jun 27, 2024
Release	Jul 18, 2024
Reset	Oct 9, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 10, 2024			Jun 27, 2024
Jul 18, 2024