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Punctum Plug

Phase 3

Post Ocular Surgical Inflammation and Pain | Small molecule | Ophthalmology |Ocular Therapeutix, Inc.|Last Updated: Jan 31, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment247

FDA Designations

No designations recorded

Clinical trial landscape

Punctum Plug · 1 trial · 1 indication

Phase 3 1
NCT02034019Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract SurgeryPost Ocular Surgical Inflammation and Pain
COMPLETED247 Analytics
PHASE3COMPLETED
Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Post Ocular Surgical Inflammation and PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Absence of Cells in Anterior Chamber of the Study Eye
Day 14
Absence of Pain in Study Eye
Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OTX-DP (Dexamethasone Punctum Plug)ACTIVE_COMPARATORResorbable hydrogel drug delivery vehicle containing dexamethasone
PVPP (Placebo Punctum Plug)PLACEBO_COMPARATORResorbable hydrogel drug delivery vehicle containing no drug

Interventions

NameTypeDescription
DexamethasoneDRUG -
Punctum PlugDRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens * Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes Exclusion Criteri...

Countries:United States
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Frequently asked questions about Punctum Plug

What is Punctum Plug used for?

Punctum Plug is an investigational small molecule being developed for post ocular surgical inflammation and pain. It is designed to treat inflammation and pain that occur after ocular surgery. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

What does Punctum Plug target?

Punctum Plug is a small molecule developed by Ocular Therapeutix, Inc. (OCUL) for the treatment of post ocular surgical inflammation and pain. The specific molecular target of Punctum Plug has not been disclosed in the available information.

Who makes Punctum Plug?

Punctum Plug is being developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OCUL. The company is conducting clinical trials to evaluate the safety and efficacy of Punctum Plug for post ocular surgical inflammation and pain.

What phase is Punctum Plug in?

Punctum Plug is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 3 study evaluating its safety and efficacy for ocular inflammation and pain after cataract surgery has been completed.

What clinical trials is Punctum Plug in?

Punctum Plug has one completed Phase 3 clinical trial, identified as NCT02034019. This study evaluated the safety and efficacy of OTX-DP for the treatment of ocular inflammation and pain after cataract surgery. The trial enrolled 247 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is Punctum Plug the same as OTX-DP?

Yes, Punctum Plug is also known as OTX-DP. The Phase 3 clinical trial NCT02034019, which evaluated the safety and efficacy of OTX-DP for ocular inflammation and pain after cataract surgery, is the trial for Punctum Plug.