A Phase 2 Study of the Latanoprost Punctal Plug Delivery... | NCT00855517

Studies
A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

NCT00855517

Sponsor

Mati Therapeutics Inc.

Status

Withdrawn

Last Update Posted

Sep 17, 2013Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Glaucoma
Ocular Hypertension

Interventions

Latanoprost-PPDS

Countries

Not provided

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

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

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor's decision

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jul 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Mar 2, 2009

First Submission Date that Met QC Criteria

Mar 3, 2009

First Posted Date

Mar 4, 2009Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2013

Last Update Posted Date

Sep 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.

Detailed Description

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Punctal Plug	Experimental		Drug: Latanoprost-PPDS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Latanoprost-PPDS	Drug	Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.	Punctal Plug

Measure	Description	Time Frame
IOP change from baseline		6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 yrs of age with ocular hypertension or open-angle glaucoma
Subjects who have a best corrected visual acuity of 20/100 or better

Exclusion Criteria:

Subjects who wear contact lenses.
Uncontrolled medical conditions
Subjects requiring chronic topical artifical tears, lubricants and/or requiring any other chronic topical medications
Subjects who have a history of chronic or recurrent inflammatory eye disease

Accepts Healthy Volunteers

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

Name	Affiliation	Role
Oscar Cuzzani, MD	QLT Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided