GlaucomaPhase 4NCT01336569

Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

A Phase 4 study testing Travoprost 0.004%/timolol maleate 0.5% fixed combination in people with Glaucoma, run by Alcon Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma
What is being tested?: Travoprost 0.004%/timolol maleate 0.5% fixed combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Feb 2011to Mar 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
Other protocol-defined inclusion criteria may apply.

Who cannot join

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;

Show all 10Show fewer

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;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)

Conditions: Glaucoma
Being tested: Travoprost 0.004%/timolol maleate 0.5% fixed combination
Keywords: Primary Open-Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma, IOP
Medical subject headings: Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Travoprost 0.004%/timolol maleate 0.5% fixed combinationDrug
Also called DuoTrav

Study groups in NCT01336569
Study group	Role	What they receive
DuoTrav	Experimental	Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks Receives: Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Mar 2012

First posted18 Apr 2011 (estimated)
Study startFeb 2011
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01336569
Sponsor's protocol ID: SMA-09-26
Status last verified: May 2013
First submitted: 14 Apr 2011
Last updated: 8 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)
ClinicalTrials.gov ID: NCT01336569
Acronym / sponsor ID: SMA-09-26
Conditions: Glaucoma
Keywords: Primary Open-Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma, IOP
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 18 Apr 2011 (estimated)
Results: Posted 8 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DuoTrav	Experimental	Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combinationTravoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Travoprost 0.004%/timolol maleate 0.5% fixed combinationAlso: DuoTrav	Drug	DuoTrav

Primary outcome

Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)
Time frame: Baseline, up to 6 weeks
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.

Results and safety

Results posted to the registry on 8 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DuoTrav	49	45

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

Time frame: Baseline, up to 6 weeks. Mean (Standard Deviation). Unit: millimeters mercury (mmHg)

Measure	DuoTrav n = 45
Value	-5.0 (3.6)

Population analysed: Intent-to-Treat (ITT): All participants who received study medication and had at least one on-therapy study visit.

Adverse events

Time frame: Adverse events were collected for the duration of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DuoTrav	1 of 49 (2%)	0 of 49 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abayomi Ogundele, PharmD study director

Alcon Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Travoprost 0.004%/timolol maleate 0.5% fixed combination in people with Glaucoma, run by Alcon Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy) (time frame: Baseline, up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01336569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.