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OTX-DP

Phase 2

Ocular Inflammation and Pain | Small molecule | Ophthalmology |Ocular Therapeutix, Inc.|Last Updated: Oct 19, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

OTX-DP · 1 trial · 1 indication

Phase 2 1
NCT01666210Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract SurgeryOcular Inflammation and Pain
COMPLETED60 Analytics
PHASE2COMPLETED
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Ocular Inflammation and PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Absence of Cells in Anterior Chamber of Study Eye
Day 8
Absence of Pain in the Study Eye
Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dexamethasone Punctum PlugACTIVE_COMPARATORSustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
Placebo Vehicle Punctum PlugPLACEBO_COMPARATORPlacebo punctum plug insertion

Interventions

NameTypeDescription
OTX-DP (Dexamethasone punctum plug)DRUGSustained and tapered release of dexamethasone from hydrogel punctum plug
Placebo Vehicle Punctum PlugDRUGHydrogel punctum plug without dexamethasone
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule * Is greater than or equal to 21 years of age * Has a cataract and is expected to undergo clear corneal cataract surg...

Countries:United States
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Frequently asked questions about OTX-DP

What is OTX-DP used for?

OTX-DP is an investigational small molecule being developed for the treatment of ocular inflammation and pain, specifically for patients undergoing cataract surgery. It is administered to manage these postoperative symptoms in the eye.

Who makes OTX-DP?

OTX-DP is being developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol OCUL. The company is focused on ophthalmic therapies.

What phase is OTX-DP in?

OTX-DP is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 2 study evaluating its safety and efficacy has been completed.

What clinical trials is OTX-DP in?

OTX-DP has one completed Phase 2 clinical trial, registered as NCT01666210. This study evaluated the safety and efficacy of OTX-DP for treating ocular inflammation and pain after cataract surgery in 60 participants in the United States.

Is OTX-DP the same as any other drug?

OTX-DP is the investigational name for this drug candidate. No alternative names have been reported for this asset, and it is distinct from other products in Ocular Therapeutix's pipeline.