A Study to Evaluate the Long Term Safety of OTX-TP (Susta... | NCT04061044

Studies
A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert

NCT04061044

Sponsor

Ocular Therapeutix, Inc.

Status

Completed

Last Update Posted

Jun 9, 2023Actual

Enrollment

40Actual

Phase

Phase 3

Conditions

Open Angle Glaucoma and Ocular Hypertension

Interventions

Ophthalmic Insert

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

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2018Actual

Primary Completion Date

Feb 10, 2020Actual

Completion Date

Sep 22, 2020Actual

First Submitted Date

Aug 15, 2019

First Submission Date that Met QC Criteria

Aug 15, 2019

First Posted Date

Aug 19, 2019Actual

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

Jun 7, 2023

Last Update Posted Date

Jun 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the long term safety of repeat dose OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental		Drug: Ophthalmic Insert

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ophthalmic Insert	Drug	Travoprost, 0.32 mg	Treatment	OTX-TP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Had prior bilateral treatment and completion, through a minimum of week 12, of the OTX-16-002 trial
Are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year
Have provided written informed consent, approved by the appropriate Institutional Review Board

Exclusion Criteria:

Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial
Had punctal or canaliculi related adverse events during the OTX-16-002 trial which required discontinuation (e.g., canaliculitis)
Used prohibited medications during the OTX-16-002 study, or the period between OTX-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy)
Missed more than 2 visits during participation in the OTX-16-002 trial

Accepts Healthy Volunteers

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

Facility	Status	City	State	ZIP	Country	Contacts
ApexEye		Cincinnati	Ohio	45242	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 11, 2019	Jun 7, 2023	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	May 26, 2020	Jun 7, 2023	SAP_001.pdf

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 13, 2023			Jun 30, 2023	5

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005901	Glaucoma
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided