Glaucoma, Open-AngleNCT01735214
An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). 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?
- Prostaglandin Analogue -Containing IOP-Lowering Therapy
- How many people
- 358 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2013to 10 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: POAG or OHT
Who may be able to join
- Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
- Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Prostaglandin Analogue -Containing IOP-Lowering Therapy
- 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.
Prostaglandin Analogue -Containing IOP-Lowering TherapyDrug
Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Patients with POAG or OHT | Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice. Receives: Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy |
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 Right Eye
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Measured: Baseline, Week 12
Change From Baseline in Intraocular Pressure (IOP) in the Left Eye
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Measured: Baseline, Week 12
Secondary outcomes (7)
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale
The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.
Measured: 12 Weeks
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale
The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.
Measured: 12 Weeks
Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks
Measured: 12 Weeks
Percentage of Participants Who Continue the New Treatment After 12 Weeks
Measured: 12 Weeks
Physician Assessment of Adherence to New Treatment Using a 4-Point Scale
The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.
Measured: 12 Weeks
Physician Assessment of Efficacy Using a 5-Point Scale
The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.
Measured: 12 Weeks
Percentage of Participants Reaching Individual IOP Target After 12 Weeks
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 posted28 Nov 2012 (estimated)
- Study start7 Mar 2013
- Primary completion10 Apr 2014
- Study completion10 Apr 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, 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
- 358 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
- NCT01735214
- Sponsor's protocol ID
- MAF/AGN/OPH/GLA/037
- Status last verified
- Apr 2019
- First submitted
- 26 Nov 2012
- Last updated
- 18 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tamcelik N, Izgi B, Temel A, Yildirim N, Okka M, Ozcan A, Yuksel N, Elgin U, Altan C, Ozer B. Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2017 Apr 19;11:723-731. doi: 10.2147/OPTH.S119963. eCollection 2017.
PubMed 28458511
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments
- ClinicalTrials.gov ID
- NCT01735214
- Acronym / sponsor ID
- MAF/AGN/OPH/GLA/037
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2013 (actual)
- Primary completion
- 10 Apr 2014 (actual)
- Study completion
- 10 Apr 2014 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Posted 27 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with POAG or OHT | – | Drug: Prostaglandin Analogue -Containing IOP-Lowering TherapyPatients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- POAG or OHT
Key inclusion criteria (2 listed)
- Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
- Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started
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 |
|---|---|---|
| Prostaglandin Analogue -Containing IOP-Lowering TherapyPatients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice. | Drug | Patients with POAG or OHT |
Primary outcome
Change From Baseline in Intraocular Pressure (IOP) in the Right Eye
Time frame: Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Change From Baseline in Intraocular Pressure (IOP) in the Left Eye
Time frame: Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
7 secondary outcomes
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale
Time frame: 12 Weeks
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale
Time frame: 12 Weeks
Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks
Time frame: 12 Weeks
Percentage of Participants Who Continue the New Treatment After 12 Weeks
Time frame: 12 Weeks
Physician Assessment of Adherence to New Treatment Using a 4-Point Scale
Time frame: 12 Weeks
Physician Assessment of Efficacy Using a 5-Point Scale
Time frame: 12 Weeks
Percentage of Participants Reaching Individual IOP Target After 12 Weeks
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 18 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28458511Tamcelik N, Izgi B, Temel A, Yildirim N, Okka M, Ozcan A, Yuksel N, Elgin U, Altan C, Ozer B. Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2017 Apr 19;11:723-731. doi: 10.2147/OPTH.S119963. eCollection 2017.
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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 Turkey (Türkiye).
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 18 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 Turkey (Türkiye). 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 27 Apr 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 Right Eye (time frame: Baseline, Week 12). 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 NCT01735214, 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 18 Apr 2019; AzTrials last refreshed its copy on 4 Nov 2026.