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The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | bimatoprost 0.03% eye drops |
|
| 2 | Active Comparator | latanoprost 0.005% eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost 0.03% eye drops | Drug | Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. | Baseline, Week 12 |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. | Baseline, Week 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost 0.03% Eye Drops | Bimatoprost 0.03% eye drops |
| FG001 | Latanoprost 0.005% Eye Drops | Latanoprost 0.005% eye drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
| |||||||||||||
| Treatment Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost 0.03% Eye Drops | Bimatoprost 0.03% eye drops |
| BG001 | Latanoprost 0.005% Eye Drops | Latanoprost 0.005% eye drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Intent to Treat (ITT) population used for Baseline characteristics. The ITT population included all patients who were randomized (started Treatment Period 2) |
| 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 Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, Week 12 |
|
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SAEs and other AEs in the Latanoprost(LAT) Arm include those events reported by pts who received LAT in Treatment Period 1 AND those who were randomized to and received LAT in Treatment Period 2. SAEs and other AEs in the Bimatoprost(BIM) Arm only include those events reported for pts who were randomized to and received BIM in Treatment Period 2.
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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 | Bimatoprost 0.03% Eye Drops | Bimatoprost 0.03% eye drops |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment | Event occurred in Treatment Period 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
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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 |
|---|---|
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D009883 | Ophthalmic Solutions |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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|
| latanoprost 0.005% eye drops | Drug | Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks |
|
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Intent to Treat (ITT) population used for Baseline characteristics. The ITT population included all patients who were randomized (started Treatment Period 2) | Count of Participants | Participants |
|
| OG001 | Latanoprost 0.005% Eye Drops | Latanoprost 0.005% eye drops |
|
|
| Primary | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, Week 18 |
|
|
|
| 4 |
| 269 |
| 59 |
| 269 |
| EG001 | Latanoprost 0.005% Eye Drops | Latanoprost 0.005% eye drops | 11 | 586 | 89 | 586 |
|
| Coronary artery disease | Cardiac disorders | MedDRA (11.1) | Systematic Assessment | Event occurred in Treatment Period 1 |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.1) | Systematic Assessment | The 2 SAEs in the Latanoprost arm occurred in Treatment Period 1 |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment | Event occurred in Treatment Period 1 |
|
| Aortic anyeurysm | Vascular disorders | MedDRA (11.1) | Systematic Assessment | Event occurred in Treatment Period 1 |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment | Event occurred in Treatment Period 1 |
|
| Prostamegaly | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment | Event occurred in Treatment Period 1 |
|
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
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |