Glaucoma, Open-AngleNCT01632423

A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in Germany.

Completed

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

Trial summary

This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). Read more about this study

Who is it for?: Any age
Conditions the study is for: Glaucoma, Open-Angle, Ocular Hypertension
What is being tested?: bimatoprost 0.01%
How many people: 10,337 participants
Where: 1 siteGermany
Study dates: Feb 2010to Nov 2010
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with open angle glaucoma or ocular hypertension

Who may be able to join

Diagnosed with primary open angle glaucoma or ocular hypertension
Prescribed Lumigan®

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Berlin

Other trials in Germany

About this study

This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: bimatoprost 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.

bimatoprost 0.01%Drug
Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry

Study groups in NCT01632423
Study group	Role	What they receive
POAG or OHT		Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry Receives: Drug: bimatoprost 0.01%

What is being measured

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

Change From Baseline in Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.
Measured: Baseline, 14 Weeks

Secondary outcomes (4)

Patient Assessment of Tolerability Using a 4-Point Scale
Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.
Measured: 14 Weeks
Physician Assessment of Tolerability Using a 4-Point Scale
Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.
Measured: 14 Weeks
Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks
Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.
Measured: 14 Weeks
Patients Who Will Continue Use of Lumigan® After 14 Weeks
Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.
Measured: 14 Weeks

Timeline

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

Feb 2010Nov 2010

First posted3 Jul 2012 (estimated)
Study startFeb 2010
Primary completionNov 2010
Study completionNov 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 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 10,337 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01632423
Sponsor's protocol ID: MAF/AGN/OPH/GLA/025
Status last verified: Aug 2012
First submitted: 25 Jun 2012
Last updated: 21 Sep 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

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).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

All Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
ClinicalTrials.gov ID: NCT01632423
Acronym / sponsor ID: MAF/AGN/OPH/GLA/025
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 10,337 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 3 Jul 2012 (estimated)
Results: Posted 21 Sep 2012

Clinical summary

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

This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
POAG or OHT	–	Drug: bimatoprost 0.01%Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with open angle glaucoma or ocular hypertension

Key inclusion criteria (2 listed)

Diagnosed with primary open angle glaucoma or ocular hypertension
Prescribed Lumigan®

Key exclusion criteria (1 listed)

None

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%Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry	Drug	POAG or OHT

Primary outcome

Change From Baseline in Intraocular Pressure (IOP)
Time frame: Baseline, 14 Weeks
IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

4 secondary outcomes

Patient Assessment of Tolerability Using a 4-Point Scale
Time frame: 14 Weeks
Physician Assessment of Tolerability Using a 4-Point Scale
Time frame: 14 Weeks
Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks
Time frame: 14 Weeks
Patients Who Will Continue Use of Lumigan® After 14 Weeks
Time frame: 14 Weeks

Results and safety

Results posted to the registry on 21 Sep 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
POAG or OHT	10,337	10,091

Primary outcome: Change From Baseline in Intraocular Pressure (IOP)

Time frame: Baseline, 14 Weeks. Median (Inter-Quartile Range). Unit: Millimeters of Mercury (mmHg)

Measure	POAG or OHT n = 10074
Baseline - Right Eye (N=10062)	20.0 (17.0 to 23.0)
Change from Baseline at 14 Wks-Rt Eye (N=10062)	-4.0 (-5.0 to -3.0)
Baseline - Left Eye (N=10074)	20.0 (17.0 to 23.0)
Change from Baseline at 14 Wks-Lft Eye (N=10074)	-4.0 (-5.0 to -3.0)

Population analysed: All enrolled patients with complete data for this outcome measure

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
POAG or OHT	2 of 10,337 (0%)	0 of 10,337 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Glaucoma, Open-Angle

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
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

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?

An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in Germany.

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 1 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 21 Sep 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 Germany. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 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?

Change From Baseline in Intraocular Pressure (IOP) (time frame: Baseline, 14 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 NCT01632423.

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 21 Sep 2012; AzTrials last refreshed its copy on 6 Nov 2026.