Glaucoma, Primary Open AngleNCT01999348

A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting

An observational study of Glaucoma, Primary 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

The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician. Read more about this study

Who is it for?: Any age
Conditions the study is for: Glaucoma, Primary Open Angle, Ocular Hypertension
What is being tested?: Fixed Combination Bimatoprost and Timolol
How many people: 1,553 participants
Where: 1 siteGermany
Study dates: 25 Nov 2013to 19 Dec 2014
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 primary open-angle glaucoma or ocular hypertension

Who may be able to join

Diagnosed with primary open-angle glaucoma or ocular hypertension
Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Wiesloch

Other trials in Germany

About this study

Conditions: Glaucoma, Primary Open Angle, Ocular Hypertension
Being tested: Fixed Combination Bimatoprost and Timolol
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.

Fixed Combination Bimatoprost and TimololDrug
Also called GANFORT® UD
Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.

Study groups in NCT01999348
Study group	Role	What they receive
Patients with POAG or OHT		Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks. Receives: Drug: Fixed Combination Bimatoprost and Timolol

What is being measured

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

Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).
Measured: Baseline, Final Visit (Week 8 to 12)

Secondary outcomes (6)

Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale
The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported.
Measured: Baseline, Final Visit (Week 8 to 12)
Patient Assessment of Tolerability on a 4-Point Scale
The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.
Measured: Final Visit (Week 8 to 12)
Physician Assessment of Tolerability on a 4-Point Scale
The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.
Measured: Final Visit (Week 8 to 12)
Percentage of Patients Who Discontinued Treatment
The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit
Measured: 12 Weeks
Percentage of Patients Prescribed by the Physician to Continue Treatment
The percentage of participants who continued treatment with Ganfort® UD after Week 12.
Measured: Final Visit (Week 8 to 12)
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported.
Measured: Final Visit (Week 8 to 12)

Timeline

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

25 Nov 201319 Dec 2014

First posted3 Dec 2013 (estimated)
Study start25 Nov 2013
Primary completion19 Dec 2014
Study completion19 Dec 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glaucoma, Primary 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: 1,553 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01999348
Sponsor's protocol ID: MAF/AGN/OPH/GLA/039
Status last verified: Apr 2019
First submitted: 26 Nov 2013
Last updated: 19 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pfennigsdorf S, Eschstruth P, Hasemeyer S, Feuerhake C, Brief G, Grobeiu I, Shirlaw A. Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice. Clin Ophthalmol. 2016 Sep 20;10:1837-1846. doi: 10.2147/OPTH.S106159. eCollection 2016.
PubMed 27703324

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, Primary Open Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting
ClinicalTrials.gov ID: NCT01999348
Acronym / sponsor ID: MAF/AGN/OPH/GLA/039
Conditions: Glaucoma, Primary Open Angle, Ocular Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 1,553 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 25 Nov 2013 (actual)
Primary completion: 19 Dec 2014 (actual)
Study completion: 19 Dec 2014 (actual)
First posted: 3 Dec 2013 (estimated)
Results: Posted 9 Dec 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

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

Arm	Type	Receives
Patients with POAG or OHT	–	Drug: Fixed Combination Bimatoprost and TimololPatients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.

Who may qualify

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

Key inclusion criteria (2 listed)

Diagnosed with primary open-angle glaucoma or ocular hypertension
Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons

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
Fixed Combination Bimatoprost and TimololAlso: GANFORT® UDPatients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.	Drug	Patients with POAG or OHT

Primary outcome

Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Time frame: Baseline, Final Visit (Week 8 to 12)
IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).

6 secondary outcomes

Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale
Time frame: Baseline, Final Visit (Week 8 to 12)
Patient Assessment of Tolerability on a 4-Point Scale
Time frame: Final Visit (Week 8 to 12)
Physician Assessment of Tolerability on a 4-Point Scale
Time frame: Final Visit (Week 8 to 12)
Percentage of Patients Who Discontinued Treatment
Time frame: 12 Weeks
Percentage of Patients Prescribed by the Physician to Continue Treatment
Time frame: Final Visit (Week 8 to 12)
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
Time frame: Final Visit (Week 8 to 12)

Results and safety

Results posted to the registry on 9 Dec 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
Patients With POAG or OHT	1,553	1,433

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

Time frame: Baseline, Final Visit (Week 8 to 12). Mean (Standard Deviation). Unit: mmHg

Measure	Patients With POAG or OHT n = 1321
Baseline	22.18 (3.55)
Final Visit	16.11 (2.87)

Population analysed: Participants from the Per-protocol population, all treated participants who had no major protocol violations, with complete data available at Baseline and Final Visit for analyses.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With POAG or OHT	1 of 1,553 (0.1%)	0 of 1,553 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27703324Pfennigsdorf S, Eschstruth P, Hasemeyer S, Feuerhake C, Brief G, Grobeiu I, Shirlaw A. Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice. Clin Ophthalmol. 2016 Sep 20;10:1837-1846. doi: 10.2147/OPTH.S106159. eCollection 2016.

Related trials for Glaucoma, Primary 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.
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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
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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?

An observational study of Glaucoma, Primary 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 19 Apr 2019. 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 9 Dec 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?

Change From Baseline in Intraocular Pressure (IOP) in the Study Eye (time frame: Baseline, Final Visit (Week 8 to 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 NCT01999348, 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 19 Apr 2019.