A Dose Evaluation Study for the Latanoprost Punctal Plug... | NCT01481051 | Trialant

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A Dose Evaluation Study for the Latanoprost Punctal Plug... | NCT01481051 | Trialant

Studies
A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

NCT01481051

Sponsor

Mati Therapeutics Inc.

Status

Completed

Last Update Posted

Sep 26, 2013Estimated

Enrollment

57Actual

Phase

Phase 2

Conditions

Glaucoma
Ocular Hypertension (OH)

Interventions

Latanoprost-PPDS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT01481051

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

PPL GLAU 12

Secondary IDs

Not provided

Brief Title

A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Official Title

PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Acronym

Not provided

Organization

Mati Therapeutics Inc.INDUSTRY

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Nov 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Nov 25, 2011

First Submission Date that Met QC Criteria

Nov 25, 2011

First Posted Date

Nov 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 16, 2013

Certification/Extension First Submitted that Passed QC Review

Sep 16, 2013

Certification/Extension First Posted Date

Sep 19, 2013Estimated

Last Update Submitted Date

Sep 19, 2013

Last Update Posted Date

Sep 26, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Mati Therapeutics Inc.INDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.

Detailed Description

Not provided

Conditions Module

Conditions

Glaucoma
Ocular Hypertension (OH)

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Latanoprost-PPDS	Drug	Sustained delivery for 12 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOP change from baseline		12 weeks to baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female at least 18 years old
Diagnosis of bilateral open angle glaucoma or ocular hypertension
Unmedicated IOP must be ≥22mm Hg

Exclusion Criteria:

Any significant vision loss in the last year
No contact lens use for the length of the study
Abnormal eye lids, eye infection, or diseases to the eye
Recent eye surgery
Uncontrolled medication conditions

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suzanne Cadden	QLT Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sall Research Medical Center, Inc		Artesia	California	90701	United States
Wolstan & Goldberg Eye Associates

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

N/A

Intervention Model

Single Group Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

Los Angeles

California

90505

United States

West Coast Eye Care Associates

San Diego

California

92115

United States

Coastal Research Associates, LLC

Roswell

Georgia

30076

United States

R and R Eye Associates

San Antonio

Texas

78229

United States

Rocky Mountain Eye Care Associates

Salt Lake City

Utah

84107

United States

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided