NCT00519753

Brief Summary

The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to DuoTrav from other mono or adjunctive therapies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
522

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2007

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

August 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 18, 2016

Status Verified

January 1, 2010

Enrollment Period

1.3 years

First QC Date

August 21, 2007

Last Update Submit

November 17, 2016

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline)

    Baseline and 12 weeks

Secondary Outcomes (1)

  • Change in intraocular pressure at 12 weeks from other prior therapies (baseline)

    12 weeks

Study Arms (1)

DuoTrav

EXPERIMENTAL

One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks

Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)

Interventions

Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)DRUG

One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks

Also known as: DUOTRAV®
DuoTrav

Eligibility Criteria

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

You may qualify if:

  • Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma.

You may not qualify if:

  • Age related.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mainz

Mainz, DE-55101, Germany

Location

Related Publications (1)

  • Pfeiffer N, Scherzer ML, Maier H, Schoelzel S, Jasek MC, Stewart JA, Stewart WC. Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy. Clin Ophthalmol. 2010 May 14;4:459-66. doi: 10.2147/opth.s10694.

    PMID: 20505839RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

TravoprostTimololDuotrav

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • Mark C Jasek

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 23, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 18, 2016

Record last verified: 2010-01

Locations

DE(1)