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Insert

Phase 3

Open Angle Glaucoma and Ocular Hypertension | Small molecule | Ophthalmology |Ocular Therapeutix, Inc.|Trials Updated: Jun 9, 2023

Insert target and mechanism

ModalitySmall molecule

Also known as Ophthalmic Insert

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Insert clinical trials

Insert · 1 trial · 1 indication

Phase 3 1
NCT04061044A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular InsertOpen Angle Glaucoma and Ocular Hypertension
COMPLETED40 Analytics
PHASE3COMPLETED
A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert
Open Angle Glaucoma and Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTAL -

Interventions

NameTypeDescription
Ophthalmic InsertDRUGTravoprost, 0.32 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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, approve...

Countries:United States
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Frequently asked questions about Insert

What is Insert used for?

Insert is an investigational ophthalmic insert being developed for open angle glaucoma and ocular hypertension. It is designed to be placed in the eye to deliver sustained-release travoprost, a small molecule therapy. It is not yet approved and remains in clinical development.

Who is developing Insert?

Insert is being developed by Ocular Therapeutix, Inc., which trades on the Nasdaq under the ticker OCUL. The company is the sponsor of the clinical program evaluating the insert for open angle glaucoma and ocular hypertension.

What phase is Insert in?

Insert is in Phase 3 clinical development. A Phase 3 study evaluating the long-term safety of the sustained-release travoprost intracanalicular insert has been completed. The program remains investigational and has not been approved for commercial use.

What clinical trials is Insert in?

Insert has been studied in one completed Phase 3 trial, NCT04061044, titled A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert. The trial enrolled 40 participants in the United States and evaluated patients with open angle glaucoma and ocular hypertension.

Is Insert the same as Ophthalmic Insert?

Yes, Insert is also known as Ophthalmic Insert. Both names refer to the same investigational sustained-release travoprost intracanalicular insert developed by Ocular Therapeutix for open angle glaucoma and ocular hypertension.