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The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with POAG or OHT | Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed Combination Bimatoprost and Timolol | Drug | Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement). | Baseline, Final Visit (Week 8 to 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported. | Baseline, Final Visit (Week 8 to 12) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with primary open-angle glaucoma or ocular hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wiesloch | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27703324 | Background | Pfennigsdorf S, Eschstruth P, Hasemeyer S, Feuerhake C, Brief G, Grobeiu I, Shirlaw A. Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice. Clin Ophthalmol. 2016 Sep 20;10:1837-1846. doi: 10.2147/OPTH.S106159. eCollection 2016. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With POAG or OHT | Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With POAG or OHT | Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Study Eye | IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement). | Participants from the Per-protocol population, all treated participants who had no major protocol violations, with complete data available at Baseline and Final Visit for analyses. | Posted | Mean | Standard Deviation | mmHg | Baseline, Final Visit (Week 8 to 12) |
|
Up to 12 Weeks
Participating physicians were required to document all serious adverse events (SAEs), irrespective of relationship, and all non-serious adverse drug reactions (ADRs).
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| 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 treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 17.1 | Systematic Assessment | The patient died at the age of 78 years. According to the attending ophthalmologist, no further information regarding cause of death was available. The physician assessed the causal relation between the fatal outcome and Ganfort® UD as 'unrelated'. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Patient Assessment of Tolerability on a 4-Point Scale | The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. | Final Visit (Week 8 to 12) |
| Physician Assessment of Tolerability on a 4-Point Scale | The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. | Final Visit (Week 8 to 12) |
| Percentage of Patients Who Discontinued Treatment | The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit | 12 Weeks |
| Percentage of Patients Prescribed by the Physician to Continue Treatment | The percentage of participants who continued treatment with Ganfort® UD after Week 12. | Final Visit (Week 8 to 12) |
| Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported. | Final Visit (Week 8 to 12) |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported. | Per-protocol population included all treated participants who had no major protocol violations. | Posted | Number | participants | Baseline, Final Visit (Week 8 to 12) |
|
|
|
| Secondary | Patient Assessment of Tolerability on a 4-Point Scale | The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. | Per-protocol population included all treated participants who had no major protocol violations. | Posted | Number | participants | Final Visit (Week 8 to 12) |
|
|
|
| Secondary | Physician Assessment of Tolerability on a 4-Point Scale | The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. | Per-protocol population included all treated participants who had no major protocol violations. | Posted | Number | participants | Final Visit (Week 8 to 12) |
|
|
|
| Secondary | Percentage of Patients Who Discontinued Treatment | The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit | Per-protocol population included all treated participants who had no major protocol violations. | Posted | Number | percentage of participants | 12 Weeks |
|
|
|
| Secondary | Percentage of Patients Prescribed by the Physician to Continue Treatment | The percentage of participants who continued treatment with Ganfort® UD after Week 12. | Per-protocol population included all treated participants who had no major protocol violations. | Posted | Number | percentage of participants | Final Visit (Week 8 to 12) |
|
|
|
| Secondary | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported. | All participants from the Per-protocol population, all treated participants who had no major protocol violations, who received previous treatment. | Posted | Number | participants | Final Visit (Week 8 to 12) |
|
|
|
| 1 |
| 1,553 |
| 0 |
| 1,553 |
|
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.
| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| Title | Measurements |
|---|---|
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| Missing data |
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| Title | Measurements |
|---|
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| Poor |
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| Missing |
|
| Title | Measurements |
|---|
|
| Poor |
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| Missing |
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| Title | Measurements |
|---|
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| Missing |
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