NCT00967811

Brief Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

9 months

First QC Date

August 27, 2009

Last Update Submit

September 16, 2013

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • IOP change from baseline

    12 weeks

Study Arms (2)

1. Formulation E1

EXPERIMENTAL

Formulation E1 of Latanoprost-PPDS

Drug: Formulation E1 of L-PPDS

2. Formulation E2

EXPERIMENTAL

Formulation E2 of Latanoprost-PPDS

Drug: Formulation E2 of L-PPDS

Interventions

Formulation E1 of L-PPDSDRUG

Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

1. Formulation E1
Formulation E2 of L-PPDSDRUG

Control of IOP compared to baseline for Formulation E2 of experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

2. Formulation E2

Eligibility Criteria

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

You may qualify if:

  • Subjects over 18 years of age diagnosed 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
  • Subjects who have uncontrolled medical conditions
  • Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular 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 (1)

Unknown Facility

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Oscar Cuzzani, MD

    QLT Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 27, 2009

First Posted

August 28, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

US(1)