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Insert

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

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 Hypertension
NCT0406104440
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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 in Open Angle Glaucoma and Ocular Hypertension?

Insert is an investigational small molecule being studied for the treatment of Open Angle Glaucoma and Ocular Hypertension. It is a sustained release travoprost intracanalicular insert developed by Ocular Therapeutix, Inc. (NASDAQ: OCUL). The drug is currently in Phase 3 clinical development.

What does Insert target?

Insert contains travoprost, a prostaglandin analog that works by increasing the outflow of aqueous humor from the eye, thereby reducing intraocular pressure. This mechanism is intended to treat Open Angle Glaucoma and Ocular Hypertension by lowering elevated pressure within the eye.

Who makes Insert?

Insert is being developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol OCUL. The company is conducting clinical trials to evaluate the safety and efficacy of this sustained release travoprost intracanalicular insert for ophthalmic conditions.

What phase is Insert in?

Insert is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 study has been completed to evaluate the long-term safety of the sustained release travoprost intracanalicular insert in patients with Open Angle Glaucoma and Ocular Hypertension.

What clinical trials is Insert in?

Insert has one completed Phase 3 clinical trial registered as NCT04061044, titled "A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert." The study enrolled 40 participants in the United States, with a minimum age of 18 years, and was not randomized or double-blinded.