Open-angle GlaucomaPhase 4NCT00508469

Adherence Assessment With Travalert Dosing Aid

A Phase 4 study testing Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav), Travoprost 0.004% eye drops and Timolol 0.05% eye drops in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Spain.

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 the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-angle Glaucoma, Ocular Hypertension
What is being tested?: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav), Travoprost 0.004% eye drops and Timolol 0.05% eye drops
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteSpain
Study dates: Oct 2007to Jan 2010
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

Diagnosis of open-angle glaucoma or ocular hypertension;
Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%;
Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy;
Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs;
Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit;
History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye;
History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue;
History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication;

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Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye;
Any abnormality preventing reliable applanation tonometry of either eye;
Best-corrected visual acuity worse than 20/30 Snellen in either eye;
Use of any additional topical or systemic ocular hyposensitive medication during the study;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Zaragoza
Zaragoza, 50009

Other trials in Spain

About this study

Official title: Adherence of Patients Using Travalert® for Instillation of a Fixed Combination of Travoprost 0.004%/Timolol 0.5% Compared to a Concomitant Regimen of Travoprost 0.004% and Timolol 0.5%

Conditions: Open-angle Glaucoma, Ocular Hypertension
Being tested: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav), Travoprost 0.004% eye drops, Timolol 0.05% eye drops, Travalert Dosing Aid
Keywords: Intraocular pressure, Open-angle glaucoma, Ocular hypertension, Adherence, Compliance
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension, Patient Compliance

What participants receive

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

Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)Drug
Also called DuoTrav®
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
Travoprost 0.004% eye dropsDrug
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
Timolol 0.05% eye dropsDrug
One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.
Travalert Dosing AidDevice
Approved device used with study medication to record time of instillation and quantify dosing

Study groups in NCT00508469
Study group	Role	What they receive
Travalert with travoprost/timolol fixed combination	Experimental	One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. Receives: Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav); Device: Travalert Dosing Aid
Travalert with travoprost and timolol	Experimental	One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication. Receives: Drug: Travoprost 0.004% eye drops; Drug: Timolol 0.05% eye drops; Device: Travalert Dosing Aid

What is being measured

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

Adherence
Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.
Measured: 6 months

Timeline

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

Oct 2007Jan 2010

First posted30 Jul 2007 (estimated)
Study startOct 2007
Primary completionJan 2010
Study completionJan 2010

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 Open-angle GlaucomaStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00508469
Sponsor's protocol ID: EMD-06-03
Status last verified: Jun 2012
First submitted: 26 Jul 2007
Last updated: 12 Jul 2012
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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All Open-angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adherence of Patients Using Travalert® for Instillation of a Fixed Combination of Travoprost 0.004%/Timolol 0.5% Compared to a Concomitant Regimen of Travoprost 0.004% and Timolol 0.5%
ClinicalTrials.gov ID: NCT00508469
Acronym / sponsor ID: EMD-06-03
Conditions: Open-angle Glaucoma, Ocular Hypertension
Keywords: Intraocular pressure, Open-angle glaucoma, Ocular hypertension, Adherence, Compliance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 30 Jul 2007 (estimated)
Results: Posted 12 Jul 2012

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Travalert with travoprost/timolol fixed combination	Experimental	Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav), Device: Travalert Dosing AidOne drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
Travalert with travoprost and timolol	Experimental	Drug: Travoprost 0.004% eye drops, Drug: Timolol 0.05% eye drops, Device: Travalert Dosing AidOne drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of open-angle glaucoma or ocular hypertension;
Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%;
Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (11 listed)

Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy;
Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs;
Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit;
History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye;
History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue;

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 0.5% fixed combination eye drops (DuoTrav)Also: DuoTrav®One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.	Drug	Travalert with travoprost/timolol fixed combination
Travoprost 0.004% eye dropsOne drop in the study eye once daily at 9 p.m. for six months using the Travalert device.	Drug	Travalert with travoprost and timolol
Timolol 0.05% eye dropsOne drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.	Drug	Travalert with travoprost and timolol
Travalert Dosing AidApproved device used with study medication to record time of instillation and quantify dosing	Device	Travalert with travoprost and timolol, Travalert with travoprost/timolol fixed combination

Primary outcome

Adherence
Time frame: 6 months
Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.

Results and safety

Results posted to the registry on 12 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Travalert With Travoprost/Timolol Fixed Combination	52	35
Travalert With Travoprost and Timolol	50	40

Primary outcome: Adherence

Time frame: 6 months. Number. Unit: percentage of adherent patients

Measure	Travalert With Travoprost/Timolol Fixed Combination n = 43	Travalert With Travoprost and Timolol n = 42
Value	63	43

Population analysed: Per protocol

Adverse events

Time frame: Adverse events were collected for the duration of the study: 2 years, 3 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Travalert With Travoprost/Timolol Fixed Combination	1 of 52 (1.9%)	0 of 52 (0%)	Not reported
Travalert With Travoprost and Timolol	1 of 50 (2%)	0 of 50 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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.

Dr Francisco M. Honrubia study director

Independent

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

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 11 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 12 Jul 2012. 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 Spain. 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 12 Jul 2012). 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?

Adherence (time frame: 6 months). 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 NCT00508469.

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 12 Jul 2012.