NCT00465803

Brief Summary

The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at below P25 for phase_3

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

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Last Updated

July 24, 2014

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

April 23, 2007

Last Update Submit

July 22, 2014

Conditions

Open-angle GlaucomaOcular Hypertension

Keywords

Open-angle glaucoma or ocular hypertension

Outcome Measures

Primary Outcomes (1)

  • Patient compliance

    Patient compliance will be measured with a dosing aid that records time and date of study drug administration

    12 months

Study Arms (2)

DuoTrav

OTHER

One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid

Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution

Travatan/Timolol

OTHER

One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.

Drug: Travoprost ophthalmic solution, 0.004%Drug: Timolol maleate ophthalmic solution, 0.5%

Interventions

Travoprost 0.004%/timolol 0.5% ophthalmic solutionDRUG

One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid

Also known as: DuoTrav
DuoTrav
Travoprost ophthalmic solution, 0.004%DRUG

One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid

Also known as: TRAVATAN
Travatan/Timolol
Timolol maleate ophthalmic solution, 0.5%DRUG

One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid

Travatan/Timolol

Eligibility Criteria

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

You may qualify if:

  • Adult patients with open-angle glaucoma or ocular hypertension;

You may not qualify if:

  • Visual acuity worse than 0.60;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

TravoprostTimololOphthalmic SolutionsDuotrav

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Theresa Landry

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 25, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2009

Last Updated

July 24, 2014

Record last verified: 2012-05

Locations

US(1)