Glaucoma, Open-AngleNCT01489670
Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in Switzerland.
Trial summary
This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 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
- 387 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2011to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with primary open-angle glaucoma or ocular hypertension
Who may be able to join
- Diagnosis of primary open-angle glaucoma or ocular hypertension
- Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.
- 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%
Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Lumigan® 0.01% | Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. 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 eye at Baseline.
Measured: Baseline
Intraocular Pressure (IOP) at Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.
Measured: Week 12
Secondary outcomes (5)
Physician Evaluation of Efficacy Using a 5-Point Scale
The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.
Measured: Week 12
Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale
Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.
Measured: Week 12
Physician Evaluation of Tolerability of Treatment
The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.
Measured: Week 12
Physician Reported Reasons for Early Discontinuation of Treatment
The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.
Measured: 12 Weeks
Number of Patients Continuing Treatment After 12 Weeks
The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionMar 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
- 387 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
- NCT01489670
- Sponsor's protocol ID
- MAF/AGN/OPH/GLA/032
- Status last verified
- Feb 2014
- First submitted
- 1 Dec 2011
- Last updated
- 28 Mar 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 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01489670
- Acronym / sponsor ID
- MAF/AGN/OPH/GLA/032
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Dec 2011 (estimated)
- Results
- Posted 28 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumigan® 0.01% | – | Drug: bimatoprost 0.01% ophthalmic solutionPatients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with primary open-angle glaucoma or ocular hypertension
Key inclusion criteria (2 listed)
- Diagnosis of primary open-angle glaucoma or ocular hypertension
- Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy
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%Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. | 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 eye at Baseline.
Intraocular Pressure (IOP) at Week 12
Time frame: Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.
5 secondary outcomes
Physician Evaluation of Efficacy Using a 5-Point Scale
Time frame: Week 12
Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale
Time frame: Week 12
Physician Evaluation of Tolerability of Treatment
Time frame: Week 12
Physician Reported Reasons for Early Discontinuation of Treatment
Time frame: 12 Weeks
Number of Patients Continuing Treatment After 12 Weeks
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 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 Switzerland.
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 28 Mar 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 Switzerland. 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 Mar 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 28 Mar 2014.