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Latanoprost Punctal Plug Delivery System

Phase 2

Ocular Hypertension | Small molecule | Ophthalmology |cbdMD, Inc.|Last Updated: Jan 10, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

Latanoprost Punctal Plug Delivery System · 1 trial · 2 indications

Phase 2 1
NCT01037036A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAGOcular Hypertension
COMPLETED15 Analytics
PHASE2COMPLETED
A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG
Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in IOP measurements
4 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Latanoprost Punctal Plug Delivery System followed by XalatanEXPERIMENTALSubjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Interventions

NameTypeDescription
Latanoprost Punctal Plug Delivery SystemDRUGTo evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.
XalatanDRUGSubjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.
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Eligibility Criteria

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

Inclusion Criteria: * Over 18 years * Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension * Currently on prostaglandin therapy Exclusion Criteria: * Uncontrolled medical conditions * Subjects who wear contact lenses * Subjects requiring chronic topical artificial tears, lubricants...

Countries:United States
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Competitive Landscape -Ocular Hypertension 8 trials

Frequently asked questions about Latanoprost Punctal Plug Delivery System

What is Latanoprost Punctal Plug Delivery System used for?

Latanoprost Punctal Plug Delivery System is an investigational small molecule being studied for ocular hypertension, a condition of elevated pressure inside the eye. It is also being evaluated in patients with open-angle glaucoma. The drug is delivered via a punctal plug, a device inserted into the tear duct to release medication over time.

Who makes Latanoprost Punctal Plug Delivery System?

Latanoprost Punctal Plug Delivery System is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is advancing this ophthalmology asset through clinical development, with the drug currently in Phase 2 trials.

What phase is Latanoprost Punctal Plug Delivery System in?

Latanoprost Punctal Plug Delivery System is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and effectiveness. One Phase 2 trial has been completed, with no active trials currently ongoing.

What clinical trials is Latanoprost Punctal Plug Delivery System in?

Latanoprost Punctal Plug Delivery System has one completed clinical trial, identified as NCT01037036. This Phase 2 study, titled 'A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG,' enrolled 15 participants in the United States with ocular hypertension or open-angle glaucoma. The trial was uncontrolled and not randomized or blinded.

How does Latanoprost Punctal Plug Delivery System work?

Latanoprost Punctal Plug Delivery System is a small molecule that delivers latanoprost, a prostaglandin analog, through a punctal plug inserted into the tear duct. This mechanism allows for sustained release of the medication to lower intraocular pressure, addressing the underlying pressure elevation in ocular hypertension and open-angle glaucoma.