NCT00855517

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Status
withdrawn

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, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

March 2, 2009

Last Update Submit

September 16, 2013

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • IOP change from baseline

    6 weeks

Study Arms (1)

Punctal Plug

EXPERIMENTAL
Drug: Latanoprost-PPDS

Interventions

Latanoprost-PPDSDRUG

Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

Punctal Plug

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Oscar Cuzzani, MD

    QLT Inc.

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 4, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

September 17, 2013

Record last verified: 2013-09