Glaucoma, Open-AngleNCT01646151
A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 2 sites in 2 countries.
Trial summary
An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice. 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
- How many people
- 2,580 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2012to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with POAG and OHT
Who may be able to join
- Diagnosis of POAG or OHT
- Previous use of IOP-lowering medication
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Bimatoprost
- 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.
BimatoprostDrug
Also called LUMIGAN®, GANFORT®
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost | Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks. Receives: Drug: Bimatoprost |
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 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.
Measured: Week 12
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 12
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 12
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 12
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 12
Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment
Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.
Measured: 12 Weeks
Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops
Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.
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 posted20 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionApr 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
- 2,580 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
- NCT01646151
- Sponsor's protocol ID
- MAF/AGN/OPH/GLA/033
- Status last verified
- May 2014
- First submitted
- 18 Jul 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 Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01646151
- Acronym / sponsor ID
- MAF/AGN/OPH/GLA/033
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,580 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Jul 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.
An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost | – | Drug: BimatoprostBimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with POAG and OHT
Key inclusion criteria (2 listed)
- Diagnosis of POAG or OHT
- Previous use of IOP-lowering medication
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 |
|---|---|---|
| BimatoprostAlso: LUMIGAN®, GANFORT®Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks. | Drug | Bimatoprost |
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 12
Time frame: Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.
6 secondary outcomes
Physician Evaluation of IOP Lowering in the Study Eye(s)
Time frame: Week 12
Patient Assessment of Tolerability on a 4-Point Scale
Time frame: Week 12
Physician Assessment of Tolerability on a 4-Point Scale
Time frame: Week 12
Physician Assessment of Patient Compliance Compared to Previous Therapy
Time frame: Week 12
Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment
Time frame: 12 Weeks
Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops
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 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
2 sites in 2 countries: 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 2 sites in 2 countries.
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 2 sites in Germany, Netherlands. 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.