NCT01481051

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

6 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

November 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

November 25, 2011

Last Update Submit

September 19, 2013

Conditions

GlaucomaOcular Hypertension (OH)

Outcome Measures

Primary Outcomes (1)

  • IOP change from baseline

    12 weeks to baseline

Interventions

Latanoprost-PPDSDRUG

Sustained delivery for 12 weeks

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sall Research Medical Center, Inc

Artesia, California, 90701, United States

Location

Wolstan & Goldberg Eye Associates

Los Angeles, California, 90505, United States

Location

West Coast Eye Care Associates

San Diego, California, 92115, United States

Location

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

Location

R and R Eye Associates

San Antonio, Texas, 78229, United States

Location

Rocky Mountain Eye Care Associates

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Suzanne Cadden

    QLT Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2011

First Posted

November 29, 2011

Study Start

November 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

US(6)