Glaucoma, Primary Open AngleNCT01853085
A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons
An observational study of Glaucoma, Primary Open Angle and Ocular Hypertension, run by Allergan at 1 site in Germany.
Trial summary
The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy 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?
- Bimatoprost Ophthalmic Solution
- How many people
- 1,830 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2013to 1 Mar 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 Lumigan® UD for medical reasons
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Being tested
- Bimatoprost Ophthalmic Solution
- 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 Ophthalmic SolutionDrug
Also called Lumigan® UD
Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patients with POAG or OHT | Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks. Receives: Drug: Bimatoprost Ophthalmic Solution |
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 Baseline
IOP is a measurement of the fluid pressure inside the study eye.
Measured: Baseline
IOP in the Study Eye at Week 12
IOP is a measurement of the fluid pressure inside the study eye.
Measured: Week 12
Secondary outcomes (6)
Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale
IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.
Measured: Baseline, 12 Weeks
Patient Assessment of Tolerability on a 4-Point Scale
Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Measured: 12 Weeks
Physician Assessment of Tolerability on a 4-Point Scale
Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Measured: 12 Weeks
Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment
Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.
Measured: 12 Weeks
Number of Patients Who Continue Treatment
Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.
Measured: 12 Weeks
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study start1 Apr 2013
- Primary completion1 Mar 2014
- Study completion1 Mar 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
- 1,830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853085
- Sponsor's protocol ID
- MAF/AGN/OPH/GLA/038
- Status last verified
- Apr 2019
- First submitted
- 10 May 2013
- Last updated
- 19 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pillunat LE, Eschstruth P, Hasemeyer S, Thelen U, Foja C, Leaback R, Pfennigsdorf S. Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice. Clin Ophthalmol. 2016 Sep 12;10:1759-65. doi: 10.2147/OPTH.S103084. eCollection 2016.
PubMed 27672307
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 Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons
- ClinicalTrials.gov ID
- NCT01853085
- Acronym / sponsor ID
- MAF/AGN/OPH/GLA/038
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,830 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Mar 2014 (actual)
- Study completion
- 1 Mar 2014 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Posted 28 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with POAG or OHT | – | Drug: Bimatoprost Ophthalmic SolutionPatients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) 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 Lumigan® 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 |
|---|---|---|
| Bimatoprost Ophthalmic SolutionAlso: Lumigan® UDPatients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks. | Drug | Patients with POAG or OHT |
Primary outcome
Intraocular Pressure (IOP) in the Study Eye at Baseline
Time frame: Baseline
IOP is a measurement of the fluid pressure inside the study eye.
IOP in the Study Eye at Week 12
Time frame: Week 12
IOP is a measurement of the fluid pressure inside the study eye.
6 secondary outcomes
Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale
Time frame: Baseline, 12 Weeks
Patient Assessment of Tolerability on a 4-Point Scale
Time frame: 12 Weeks
Physician Assessment of Tolerability on a 4-Point Scale
Time frame: 12 Weeks
Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment
Time frame: 12 Weeks
Number of Patients Who Continue Treatment
Time frame: 12 Weeks
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
Time frame: 12 Weeks
Results and safety
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 27672307Pillunat LE, Eschstruth P, Hasemeyer S, Thelen U, Foja C, Leaback R, Pfennigsdorf S. Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice. Clin Ophthalmol. 2016 Sep 12;10:1759-65. doi: 10.2147/OPTH.S103084. eCollection 2016.
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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 28 May 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 Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT01853085, 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.