Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostaglandin Analogue -Containing IOP-Lowering Therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Weeks |
| Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
POAG or OHT
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28458511 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |
| 12 Weeks |
| Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks | 12 Weeks |
| Percentage of Participants Who Continue the New Treatment After 12 Weeks | 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. | 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. | 12 Weeks |
| Percentage of Participants Reaching Individual IOP Target After 12 Weeks | 12 Weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participant with IOP data at Baseline and Week 12 for analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
|
|
| |||||||||||||||||||||||||
| Secondary | 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. | All participants with available data. | Posted | Number | percentage of participants | 12 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | All participants with data available for analysis. | Posted | Number | percentage of participants | 12 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks | All participants. | Posted | Number | percentage of participants | 12 Weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Continue the New Treatment After 12 Weeks | All participants | Posted | Number | percentage of participants | 12 Weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All Participants | Posted | Number | percentage of participants | 12 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | All participants. | Posted | Number | percentage of participants | 12 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Reaching Individual IOP Target After 12 Weeks | All participants | Posted | Number | percentage of participants | 12 Weeks |
|
| ||||||||||||||||||||||||||||
| Primary | 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. | All participant with IOP data at Baseline and Week 12 for analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 358 | 23 | 358 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperemia | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 51 to 60 years |
|
| 61 to 70 years |
|
| 71 to 80 years |
|
| 81 to 90 years |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|