NCT00862472

Brief Summary

The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.

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_3

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withdrawn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
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

March 16, 2009

Last Update Submit

January 13, 2012

Conditions

Open-angle GlaucomaOcular Hypertension

Keywords

open-angle glaucomaocular hypertensionopen-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)

Outcome Measures

Primary Outcomes (1)

  • Mean Intraocular Pressure (IOP)

    3 Months

Study Arms (2)

DuoTrav APS

EXPERIMENTAL

DuoTrav APS QD AM

Drug: DuoTrav APS

DuoTrav

ACTIVE COMPARATOR

DuoTrav QD AM

Drug: DuoTrav

Interventions

DuoTrav APSDRUG

DuoTrav APS QD AM

DuoTrav APS
DuoTravDRUG

DuoTrav QD AM

DuoTrav

Eligibility Criteria

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

You may qualify if:

  • Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication

You may not qualify if:

  • VA not worse than 0.60
  • additional clinically relevant ocular or systemic conditions may be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Duotrav

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 18, 2012

Record last verified: 2012-01