NCT00311389

Brief Summary

The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
408

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2003

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

January 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

1.7 years

First QC Date

April 4, 2006

Last Update Submit

February 11, 2012

Conditions

Glaucoma, Open-angleOcular Hypertension

Keywords

GlaucomaPOAGOAGOHT

Outcome Measures

Primary Outcomes (1)

  • Mean Intraocular Pressure (IOP)

    12 months

Study Arms (2)

Travoprost/Timolol

EXPERIMENTAL

1 drop in the affected eye(s) once daily in the morning for 12 months

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

Latanoprost/Timolol

ACTIVE COMPARATOR

1 drop in the affected eye(s) once daily in the morning for 12 months

Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution

Interventions

Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solutionDRUG

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Travoprost/Timolol
Latanoprost 0.005%/Timolol 0.005% ophthalmic solutionDRUG

Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Latanoprost/Timolol

Eligibility Criteria

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

You may qualify if:

  • \- As specified in protocol

You may not qualify if:

  • \- As specified in protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Facilitiies

Puurs, Belgium

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

TravoprostTimololOphthalmic SolutionsLatanoprost

Condition Hierarchy (Ancestors)

Eye 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 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

April 4, 2006

First Posted

April 6, 2006

Study Start

January 1, 2003

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

BE(1)