NCT01336569

Brief Summary

The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants 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
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_4

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

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 8, 2013

Completed
Last Updated

July 8, 2013

Status Verified

May 1, 2013

Enrollment Period

1.1 years

First QC Date

April 14, 2011

Results QC Date

May 17, 2013

Last Update Submit

May 17, 2013

Conditions

Glaucoma

Keywords

Primary Open-Angle GlaucomaOcular HypertensionPigment Dispersion GlaucomaIOP

Outcome Measures

Primary Outcomes (1)

  • Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)

    As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.

    Baseline, up to 6 weeks

Study Arms (1)

DuoTrav

EXPERIMENTAL

Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks

Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination

Interventions

Travoprost 0.004%/timolol maleate 0.5% fixed combinationDRUG
Also known as: DuoTrav
DuoTrav

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
  • Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
  • On a stable medication regimen for IOP reduction one week prior to the screening visit;
  • Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
  • Sign informed consent;

You may not qualify if:

  • Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
  • Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
  • Infection in either eye;
  • Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
  • Risk for visual field or visual acuity worsening, in the opinion of the investigator;
  • Women of childbearing potential;
  • Pregnant or lactating women;
  • Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
  • Participation in another clinical study within 30 days before the screening visit;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleOcular Hypertension

Interventions

TravoprostTimololDuotrav

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Doug Hubatsch, Global Brand Medical Affairs Leader, Glaucoma
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Abayomi Ogundele, PharmD

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

April 14, 2011

First Posted

April 18, 2011

Study Start

February 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 8, 2013

Results First Posted

July 8, 2013

Record last verified: 2013-05

Locations

US(1)