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 will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost SR 10 μg | Experimental | Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study. |
|
| LUMIGAN 0.01% | Other | Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost SR | Drug | Consists of 1 Bimatoprost SR administration in the study eye. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | 8 weeks |
| Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | The number of patients who experienced one or more TEAEs | Up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. The range of IOP is calculated as maximum value minus minimum value per participant for each corresponding period with the smaller values showing less fluctuation of IOP. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Research Group /ID# 232749 | Dothan | Alabama | 36301 | United States | ||
| The Eye Research Foundation /ID# 232694 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37343625 | Derived | Weinreb RN, Christie WC, Medeiros FA, Craven ER, Kim K, Nguyen A, Bejanian M, Wirta DL. Single Administration of Bimatoprost Implant: Effects on 24-Hour Intraocular Pressure and 1-Year Outcomes. Ophthalmol Glaucoma. 2023 Nov-Dec;6(6):599-608. doi: 10.1016/j.ogla.2023.06.007. Epub 2023 Jun 19. |
Not provided
Not provided
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing, please refer to the link below
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost SR 10 μg | Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study. Bimatoprost SR: Consists of 1 Bimatoprost SR administration in the study eye. |
| FG001 | LUMIGAN 0.01% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2019 | May 12, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LUMIGAN |
| Drug |
Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study. |
|
| 8 Weeks |
| Newport Beach |
| California |
| 92663-3637 |
| United States |
| Coastal Research Associates /ID# 232798 | Roswell | Georgia | 30076 | United States |
| James D Branch MD /ID# 232718 | Winston-Salem | North Carolina | 27101 | United States |
| Scott and Christie and Associates /ID# 232747 | Cranberry Township | Pennsylvania | 16066 | United States |
| Keystone Research LTD /ID# 232665 | Austin | Texas | 78731-4203 | United States |
Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study. LUMIGAN: Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) with at least 1 postbaseline IOP assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost SR 10 μg | Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study. Bimatoprost SR: Consists of 1 Bimatoprost SR administration in the study eye. |
| BG001 | LUMIGAN 0.01% | Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study. LUMIGAN: Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Baseline Hour 0 Intraocular Pressure (IOP) | 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 Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) with at least 1 postbaseline IOP assessment. | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | 8 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | The number of patients who experienced one or more TEAEs | All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) | Posted | Count of Participants | Participants | Up to 12 Months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. The range of IOP is calculated as maximum value minus minimum value per participant for each corresponding period with the smaller values showing less fluctuation of IOP. | All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) with at least 1 postbaseline IOP assessment. | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | 8 Weeks |
|
12 Months
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 | Bimatoprost SR 10 μg | Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study. Bimatoprost SR: Consists of 1 Bimatoprost SR administration in the study eye. | 0 | 31 | 1 | 31 | 20 | 31 |
| EG001 | LUMIGAN 0.01% | Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study. LUMIGAN: Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study. | 0 | 6 | 0 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONJUNCTIVAL HAEMORRHAGE | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONJUNCTIVAL HYPERAEMIA | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FOREIGN BODY SENSATION IN EYES | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PUNCTATE KERATITIS | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VISUAL FIELD DEFECT | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2021 | May 12, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| > 25 mmHg |
|
| Diurnal/Wake Period Hour 12:00 |
|
| Diurnal/Wake Period Hour 14:00 |
|
| Diurnal/Wake Period Hour 16:00 |
|
| Diurnal/Wake Period Hour 18:00 |
|
| Diurnal/Wake Period Hour 20:00 |
|
| Diurnal/Wake Period Hour 22:00 |
|
| Nocturnal/Sleep Period Hour 00:00 |
|
| Nocturnal/Sleep Period Hour 02:00 |
|
| Nocturnal/Sleep Period Hour 04:00 |
|
| Nocturnal/Sleep Period Hour 06:00 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|