Glaucoma, Open-AngleNCT01589510
A Study of Lumigan® 0.01% 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 Austria.
Trial summary
A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- bimatoprost 0.01% ophthalmic solution
- How many people
- 419 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2012to Feb 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with POAG and OHT
Who may be able to join
- Diagnosis of POAG or OHT
- Prescribed Lumigan® 0.01%
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- bimatoprost 0.01% 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 0.01% ophthalmic solutionDrug
Also called Lumigan® 0.01%
Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lumigan® 0.01% | Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks. Receives: Drug: bimatoprost 0.01% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP) at Baseline
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.
Measured: Baseline
IOP at Week 14
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.
Measured: Week 14
Secondary outcomes (6)
Physician Evaluation of IOP Lowering in the Study Eye(s)
IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.
Measured: Week 14
Patient Assessment of Tolerability on a 4-Point Scale
Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Measured: Week 14
Physician Assessment of Tolerability on a 4-Point Scale
Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Measured: Week 14
Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment
Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.
Measured: 14 Weeks
Percentage of Patients Who Continue Lumigan® 0.01% Treatment
Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.
Measured: Week 14
Physician Assessment of Patient Compliance Compared to Previous Therapy
Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013
- Study completionFeb 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 419 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
- NCT01589510
- Sponsor's protocol ID
- MAF/AGN/OPH/GLA/034
- Status last verified
- May 2014
- First submitted
- 30 Apr 2012
- Last updated
- 13 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
- ClinicalTrials.gov ID
- NCT01589510
- Acronym / sponsor ID
- MAF/AGN/OPH/GLA/034
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Posted 13 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumigan® 0.01% | – | Drug: bimatoprost 0.01% ophthalmic solutionLumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with POAG and OHT
Key inclusion criteria (2 listed)
- Diagnosis of POAG or OHT
- Prescribed Lumigan® 0.01%
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% ophthalmic solutionAlso: Lumigan® 0.01%Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks. | Drug | Lumigan® 0.01% |
Primary outcome
Intraocular Pressure (IOP) at Baseline
Time frame: Baseline
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.
IOP at Week 14
Time frame: Week 14
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.
6 secondary outcomes
Physician Evaluation of IOP Lowering in the Study Eye(s)
Time frame: Week 14
Patient Assessment of Tolerability on a 4-Point Scale
Time frame: Week 14
Physician Assessment of Tolerability on a 4-Point Scale
Time frame: Week 14
Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment
Time frame: 14 Weeks
Percentage of Patients Who Continue Lumigan® 0.01% Treatment
Time frame: Week 14
Physician Assessment of Patient Compliance Compared to Previous Therapy
Time frame: Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
- 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
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 Austria.
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 13 Jun 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 Austria. 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 13 Jun 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?
Intraocular Pressure (IOP) 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?
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 13 Jun 2014.