Glaucoma, Open-AnglePhase 4NCT01547598

Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction

A Phase 4 study testing travoprost ophthalmic solution 0.004%, travoprost 0.004% / timolol 0.5% combination ophthalmic solution and Bimatoprost ophthalmic solution 0.01% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in Canada.

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

This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Open-Angle, Ocular Hypertension
What is being tested?: travoprost ophthalmic solution 0.004%, travoprost 0.004% / timolol 0.5% combination ophthalmic solution and Bimatoprost ophthalmic solution 0.01%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 135 participants
Where: 1 siteCanada
Study dates: Dec 2011to Jul 2013
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

Open angle glaucoma or ocular hypertension
Best corrected visual acuity of 20/100 or better in both eyes

Who cannot join

Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
Previous treatment with LUMIGAN® RC or DuoTrav®
History of LASIK, LASEK, RK or PRK in the study eye(s)
Active ocular inflammation

Trial locations and contacts

1 site in 1 country.

Canada1 site

Study site
Vancouver, British Columbia

Other trials in Canada

About this study

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: travoprost ophthalmic solution 0.004%, travoprost 0.004% / timolol 0.5% combination ophthalmic solution, Bimatoprost ophthalmic solution 0.01%
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.

travoprost ophthalmic solution 0.004%Drug
Also called Travatan® Z
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
travoprost 0.004% / timolol 0.5% combination ophthalmic solutionDrug
Also called DuoTrav®
DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Bimatoprost ophthalmic solution 0.01%Drug
Also called LUMIGAN® RC
LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.

Study groups in NCT01547598
Study group	Role	What they receive
LUMIGAN® RC	Active comparator	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks. Receives: Drug: travoprost ophthalmic solution 0.004%; Drug: Bimatoprost ophthalmic solution 0.01%
DuoTrav®	Active comparator	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks. Receives: Drug: travoprost ophthalmic solution 0.004%; Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution

What is being measured

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

Mean Diurnal Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Measured: Week 12

Secondary outcomes (4)

Change From Baseline in Mean IOP at Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12
Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Measured: Baseline, Week 12
Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Measured: Week 12
Change From Baseline in Mean IOP at Week 6
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 6

Timeline

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

Dec 2011Jul 2013

First posted8 Mar 2012 (estimated)
Study startDec 2011
Primary completionJul 2013
Study completionJul 2013

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 Glaucoma, Open-AngleStudies 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: Single blind
Who is masked: Investigator
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01547598
Sponsor's protocol ID: GMA-LUM-11-020
Status last verified: Jul 2014
First submitted: 10 Feb 2012
Last updated: 15 Aug 2014
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 Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
ClinicalTrials.gov ID: NCT01547598
Acronym / sponsor ID: GMA-LUM-11-020
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 8 Mar 2012 (estimated)
Results: Posted 15 Aug 2014

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: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
LUMIGAN® RC	Active comparator	Drug: travoprost ophthalmic solution 0.004%, Drug: Bimatoprost ophthalmic solution 0.01%Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
DuoTrav®	Active comparator	Drug: travoprost ophthalmic solution 0.004%, Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solutionTravatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.

Who may qualify

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

Key inclusion criteria (2 listed)

Open angle glaucoma or ocular hypertension
Best corrected visual acuity of 20/100 or better in both eyes

Key exclusion criteria (4 listed)

Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
Previous treatment with LUMIGAN® RC or DuoTrav®
History of LASIK, LASEK, RK or PRK in the study eye(s)
Active ocular inflammation

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 ophthalmic solution 0.004%Also: Travatan® ZTravatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.	Drug	DuoTrav®, LUMIGAN® RC
travoprost 0.004% / timolol 0.5% combination ophthalmic solutionAlso: DuoTrav®DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.	Drug	DuoTrav®
Bimatoprost ophthalmic solution 0.01%Also: LUMIGAN® RCLUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.	Drug	LUMIGAN® RC

Primary outcome

Mean Diurnal Intraocular Pressure (IOP)
Time frame: Week 12
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.

4 secondary outcomes

Change From Baseline in Mean IOP at Week 12
Time frame: Baseline, Week 12
Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
Time frame: Baseline, Week 12
Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
Time frame: Week 12
Change From Baseline in Mean IOP at Week 6
Time frame: Baseline, Week 6

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LUMIGAN® RC	67	61
DuoTrav®	68	63

Primary outcome: Mean Diurnal Intraocular Pressure (IOP)

Time frame: Week 12. Mean (Standard Deviation). Unit: mmHg

Measure	LUMIGAN® RC n = 61	DuoTrav® n = 63
Value	18.6 (3.5)	17.4 (2.7)

Population analysed: Participants from the modified Intent-to-treat (mITT) population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Travatan® Z	0 of 135 (0%)	0 of 135 (0%)	Not reported
LUMIGAN® RC	0 of 67 (0%)	0 of 67 (0%)	Not reported
DuoTrav®	1 of 68 (1.5%)	0 of 68 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Glaucoma, Open-Angle

RecruitingPhase 2
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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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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.

Medical Director study director

Allergan

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 2 inclusion and 4 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 15 Aug 2014. 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 Canada. 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 15 Aug 2014). 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 Diurnal Intraocular Pressure (IOP) (time frame: Week 12). 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 NCT01547598.

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 15 Aug 2014.