NCT01037036

Brief Summary

The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

December 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 10, 2014

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

December 17, 2009

Last Update Submit

December 10, 2013

Conditions

Ocular HypertensionOpen-Angle Glaucoma

Keywords

Ocular HypertensionOpen-Angle GlaucomaXalatanIOP

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in IOP measurements

    4 weeks

Study Arms (1)

Latanoprost Punctal Plug Delivery System followed by Xalatan

EXPERIMENTAL

Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Drug: Latanoprost Punctal Plug Delivery SystemDrug: Xalatan

Interventions

Latanoprost Punctal Plug Delivery SystemDRUG

To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.

Latanoprost Punctal Plug Delivery System followed by Xalatan
XalatanDRUG

Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Latanoprost Punctal Plug Delivery System followed by Xalatan

Eligibility Criteria

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

You may qualify if:

  • Over 18 years
  • Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
  • Currently on prostaglandin therapy

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menlo Park

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Oscar Cuzanni, MD, MSc

    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

December 17, 2009

First Posted

December 21, 2009

Study Start

December 1, 2009

Primary Completion

April 1, 2010

Study Completion

July 1, 2010

Last Updated

January 10, 2014

Record last verified: 2013-12

Locations

US(1)