NCT00650702

Brief Summary

The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

September 19, 2013

Status Verified

March 1, 2011

Enrollment Period

11 months

First QC Date

March 27, 2008

Last Update Submit

September 16, 2013

Conditions

GlaucomaOcular Hypertension

Keywords

glaucoma, ocular hypertension, IOP

Outcome Measures

Primary Outcomes (1)

  • IOP change from baseline

    12 Weeks

Study Arms (3)

1

EXPERIMENTAL

Low Latanoprost-PPDS

Drug: Latanoprost-PPDS

2

EXPERIMENTAL

Medium Latanoprost-PPDS

Drug: Latanoprost-PPDS

3

EXPERIMENTAL

High Latanoprost-PPDS

Drug: Latanoprost-PPDS

Interventions

Latanoprost-PPDSDRUG

Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Artesia, California, 90701, United States

Location

Unknown Facility

Sacramento, California, 95815, United States

Location

Unknown Facility

Bel Air, Maryland, 21014, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55404, United States

Location

Unknown Facility

St Louis, Missouri, 63131, United States

Location

Unknown Facility

Lynbrook, New York, 11563, United States

Location

Unknown Facility

High Point, North Carolina, 27262, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 2, 2008

Study Start

March 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 19, 2013

Record last verified: 2011-03

Locations

US(8)