GlaucomaPhase 4NCT01881126

An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

A Phase 4 study testing bimatoprost 0.01%, travatan 0.004% and timolol 0.5% in people with Glaucoma and Ocular Hypertension, run by Allergan at 2 sites 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 efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: bimatoprost 0.01%, travatan 0.004% and timolol 0.5%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 2 sitesCanada
Study dates: Jun 2013to Oct 2014
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

Ocular hypertension or glaucoma that requires treatment with medication
Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

Who cannot join

History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Study site
Barrie, Ontario
Study site
Toronto, Ontario

Other trials in Canada

About this study

Conditions: Glaucoma, Ocular Hypertension
Being tested: bimatoprost 0.01%, travatan 0.004%, timolol 0.5%, hypromellose 0.3%
Medical subject headings: Glaucoma, Ocular Hypertension

What participants receive

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

bimatoprost 0.01%Drug
Also called Lumigan® RC, Lumigan®
Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
travatan 0.004%Drug
Also called Travatan Z®
Travatan 0.004% administered to both eyes once daily for 12 weeks.
timolol 0.5%Drug
Also called Timolol Maleate-EX, Timolol GFS
Timolol 0.5% administered to both eyes once daily for 12 weeks.
hypromellose 0.3%Drug
Also called GenTeal®
Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

Study groups in NCT01881126
Study group	Role	What they receive
bimatoprost 0.01% and hypromellose 0.3%	Active comparator	Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks. Receives: Drug: bimatoprost 0.01%; Drug: hypromellose 0.3%
travatan 0.004% and timolol 0.5%	Active comparator	Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks. Receives: Drug: travatan 0.004%; Drug: timolol 0.5%

What is being measured

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

Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.
Measured: Week 12 at 8 AM, 12 PM, and 4 PM

Timeline

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

Jun 2013Oct 2014

First posted19 Jun 2013 (estimated)
Study startJun 2013
Primary completionOct 2014
Study completionOct 2014

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.
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: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01881126
Sponsor's protocol ID: GMA-LUM-12-021
Status last verified: Oct 2015
First submitted: 17 Jun 2013
Last updated: 30 Nov 2015
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 trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01881126
Acronym / sponsor ID: GMA-LUM-12-021
Conditions: Glaucoma, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 19 Jun 2013 (estimated)
Results: Posted 30 Nov 2015

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
bimatoprost 0.01% and hypromellose 0.3%	Active comparator	Drug: bimatoprost 0.01%, Drug: hypromellose 0.3%Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
travatan 0.004% and timolol 0.5%	Active comparator	Drug: travatan 0.004%, Drug: timolol 0.5%Travatan 0.004% and timolol 0.5% each administered to both eyes once daily 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)

Ocular hypertension or glaucoma that requires treatment with medication
Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

Key exclusion criteria (3 listed)

History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study

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
bimatoprost 0.01%Also: Lumigan® RC, Lumigan®Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.	Drug	bimatoprost 0.01% and hypromellose 0.3%
travatan 0.004%Also: Travatan Z®Travatan 0.004% administered to both eyes once daily for 12 weeks.	Drug	travatan 0.004% and timolol 0.5%
timolol 0.5%Also: Timolol Maleate-EX, Timolol GFSTimolol 0.5% administered to both eyes once daily for 12 weeks.	Drug	travatan 0.004% and timolol 0.5%
hypromellose 0.3%Also: GenTeal®Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.	Drug	bimatoprost 0.01% and hypromellose 0.3%

Primary outcome

Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
Time frame: Week 12 at 8 AM, 12 PM, and 4 PM
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.

Results and safety

Results posted to the registry on 30 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bimatoprost 0.01% and Hypromellose 0.3%	47	46
Travatan 0.004% and Timolol 0.5%	46	44

Primary outcome: Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM

Time frame: Week 12 at 8 AM, 12 PM, and 4 PM. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Bimatoprost 0.01% and Hypromellose 0.3% n = 46	Travatan 0.004% and Timolol 0.5% n = 44
Week 12 at 8 AM	16.4 (0.46)	15.1 (0.43)
Week 12 at 12 PM	16.0 (0.49)	15.0 (0.38)
Week 12 at 4 PM	16.5 (0.48)	14.5 (0.34)

Population analysed: Intent-to-Treat: all subjects who were randomized to study medication

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bimatoprost 0.01% and Hypromellose 0.3%	1 of 47 (2.1%)	0 of 47 (0%)	Not reported
Travatan 0.004% and Timolol 0.5%	0 of 46 (0%)	0 of 46 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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.

Medical Director study director

Allergan

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing bimatoprost 0.01%, travatan 0.004% and timolol 0.5% in people with Glaucoma and Ocular Hypertension, run by Allergan at 2 sites in Canada.

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 3 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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 30 Nov 2015). 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?

Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM (time frame: Week 12 at 8 AM, 12 PM, and 4 PM). 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 NCT01881126.

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 30 Nov 2015.