Open Angle GlaucomaPhase 4NCT02003391

Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

A Phase 4 study testing Beta-blocker monotherapy and Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Alcon Research.

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 is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker 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: Open Angle Glaucoma, Ocular Hypertension
What is being tested?: Beta-blocker monotherapy and Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 157 participants
Where: No sites listed yet
Study dates: Dec 2013to May 2015
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

Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction.
Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.
Must be able to understand and sign an Informed Consent form.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Use of medication excluded by the protocol.
Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.
Ocular surgeries or procedures excluded by the protocol.
Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator.
Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker

Conditions: Open Angle Glaucoma, Ocular Hypertension
Being tested: Beta-blocker monotherapy, Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
Keywords: Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

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

Beta-blocker monotherapyDrug
Per participant's current prescribed therapy
Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solutionDrug
Also called DUOTRAV®

Study groups in NCT02003391
Study group	Role	What they receive
DuoTrav	Experimental	Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks. Receives: Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
Beta-blocker	Active comparator	Participant's current beta-blocker monotherapy, 1 drop instilled in the study eye twice daily (morning and evening) for 4 weeks, followed by travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 4 additional weeks. Receives: Drug: Beta-blocker monotherapy; Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution

What is being measured

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

Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
Measured: Week 4

Secondary outcomes (2)

Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Week 4
Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Week 4

Timeline

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

Dec 2013May 2015

First posted6 Dec 2013 (estimated)
Study startDec 2013
Primary completionMay 2015
Study completionMay 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Open Angle 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02003391
Sponsor's protocol ID: M-13-038
Status last verified: Jun 2016
First submitted: 2 Dec 2013
Last updated: 8 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lerner SF, Park KH, Hubatsch DA, Erichev V, Paczka JA, Roberts TV. Efficacy and Tolerability of Travoprost 0.004%/Timolol 0.5% Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy. J Ophthalmol. 2017;2017:1917570. doi: 10.1155/2017/1917570. Epub 2017 Jan 23.
PubMed 28239491

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?

Official record

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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All Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker
ClinicalTrials.gov ID: NCT02003391
Acronym / sponsor ID: M-13-038
Conditions: Open Angle Glaucoma, Ocular Hypertension
Keywords: Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Posted 8 Aug 2016

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
DuoTrav	Experimental	Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solutionTravoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks.
Beta-blocker	Active comparator	Drug: Beta-blocker monotherapy, Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solutionParticipant's current beta-blocker monotherapy, 1 drop instilled in the study eye twice daily (morning and evening) for 4 weeks, followed by travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 4 additional weeks.

Who may qualify

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

Key inclusion criteria (5 listed)

Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction.
Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.
Must be able to understand and sign an Informed Consent form.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (7 listed)

Use of medication excluded by the protocol.
Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.
Ocular surgeries or procedures excluded by the protocol.
Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
Hypersensitivity to prostaglandin analogues or any component of the study medications 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
Beta-blocker monotherapyPer participant's current prescribed therapy	Drug	Beta-blocker
Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solutionAlso: DUOTRAV®	Drug	Beta-blocker, DuoTrav

Primary outcome

Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye
Time frame: Week 4
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.

2 secondary outcomes

Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
Time frame: Baseline (Day 0), Week 4
Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
Time frame: Baseline (Day 0), Week 4

Results and safety

Results posted to the registry on 8 Aug 2016, 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	81	78
Beta-blocker	75	73

Primary outcome: Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye

Time frame: Week 4. Least squares mean (95% Confidence Interval). Unit: mmHg

Measure	DuoTrav n = 78	Beta-blocker n = 72
Value	16.6129 (NA to 17.1451)	21.2320 (NA to 21.7858)

DuoTrav vs Beta-blocker: Mean Difference (Final Values): -4.6191, p <0.0001, ANCOVA

Population analysed: Intent to treat with a measurement in the study eye at Week 4

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DuoTrav	0 of 81 (0%)	18 of 81 (22.2%)	Not reported
Beta-blocker	0 of 75 (0%)	9 of 75 (12%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28239491Lerner SF, Park KH, Hubatsch DA, Erichev V, Paczka JA, Roberts TV. Efficacy and Tolerability of Travoprost 0.004%/Timolol 0.5% Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy. J Ophthalmol. 2017;2017:1917570. doi: 10.1155/2017/1917570. Epub 2017 Jan 23.

Related trials for Open Angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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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.

Clinical Project Lead GCRA, Pharma study director

Alcon Research

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 5 inclusion and 7 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 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

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 Aug 2016). 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?

Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye (time frame: Week 4). 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 NCT02003391, which also lists 1 linked publication.

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 Aug 2016.