Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003631-34 | EudraCT Number |
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 intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) | Active Comparator | Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later. |
|
| Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) | Experimental | Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost SR | Drug | Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) at Baseline | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. | Baseline (prior to treatment) |
| Change From Baseline in IOP at Week 4 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses. | Baseline (prior to treatment) to Week 4 |
| Change From Baseline in IOP at Week 12 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. | Baseline (prior to treatment) to Week 12 |
| Change From Baseline in Intraocular Pressure (IOP) at Week 24 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. | Baseline (prior to treatment) to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in IOP at Weeks 8, 15, and 20 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. | Baseline (prior to treatment) to Weeks 8, 15 and 20 |
Not provided
Inclusion Criteria:
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Margot Goodkin | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center South | Dothan | Alabama | 36301 | United States | ||
| Arizona Eye Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943114 | Derived | Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3. |
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.
A total of 144 participants were randomized with 72 participants in each treatment group. Out of them 142 participants were treated. The primary eye was defined as the eye with the higher intraocular pressure (IOP) at Baseline. If both the eyes were the same, the right eye was used as the primary eye. The contralateral eye is the other eye.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) | Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cycle 1 (Day 1 to Week 15) |
|
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 | Mar 27, 2020 | Jan 25, 2022 |
Not provided
Not provided
Not provided
Not provided
| Sham Bimatoprost SR | Drug | Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2). |
|
| Selective Laser Trabeculoplasty | Procedure | Selective Laser Trabeculoplasty administered on Day 1. |
|
| Sham Selective Laser Trabeculoplasty | Procedure | Sham Selective Laser Trabeculoplasty administered on Day 1. |
|
| Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator |
Median time in days from first treatment to the initial use of non-study IOP-lowering treatment. |
| First treatment to end of study (up to 525 days) |
| Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3. | Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Walman Eye Center | Chandler | Arizona | 85225 | United States |
| Shasta Eye Medical Group, Inc. | Redding | California | 96002 | United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Eye Associates of Colorado Springs | Colorado Springs | Colorado | 80909 | United States |
| West Coast Eye Institute | Lecanto | Florida | 34461 | United States |
| Emory University Eye Center | Atlanta | Georgia | 30322 | United States |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Fraser Eye Center | Fraser | Michigan | 48026 | United States |
| Galanis Cataract and Laser Eye Center | St Louis | Missouri | 63119 | United States |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11563 | United States |
| Asheville Eye Associates | Asheville | North Carolina | 28803 | United States |
| James D. Branch MD | Winston-Salem | North Carolina | 27101 | United States |
| Bergstrom Eye Research, LLC | Fargo | North Dakota | 58103 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| The Cataract & Glaucoma Center | El Paso | Texas | 79902 | United States |
| DCT- Shah Research | Mission | Texas | 78572 | United States |
| San Antonio Eye Center | San Antonio | Texas | 78215 | United States |
| Vistar Eye Center | Roanoke | Virginia | 24016 | United States |
| Marsden Eye Specialists | Parramatta | New South Wales | 2150 | Australia |
| Glostrup Hospital | Glostrup Municipality | Capital Region | 2600 | Denmark |
| CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie | Bordeaux | 33076 | France |
| Prywatna Klinika Okulistyczna OFTALMIKA | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-631 | Poland |
| Centrum Diagnostykii Mikrochirurgii Oka LENS ul. | Olsztyn | Warmian-Masurian Voivodeship | 10-424 | Poland |
| S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch | Novosibirsk | 630071 | Russia |
| Ophthalmic Clinical Hospital V.P. Vyhodtseva | Omsk | 644024 | Russia |
| Singapore National Eye Centre | Singapore | 168751 | Singapore |
| Centro de Oftalmologia Barraquer | Barcelona | 8021 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital | Chiang Mai | 50200 | Thailand |
| Thammasat University Hospital | Pathum Thani | 12120 | Thailand |
| FG001 | Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) | Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. |
| Received Treatment in Either Eye |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Cycle 2 (Week 16 to Week 31) |
|
|
| Cycle 3 (Week 32 to Week 52) |
|
Intent-to-treat (ITT) Population was defined as all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) | Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later. |
| BG001 | Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) | Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Intraocular Pressure (IOP) at Baseline | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. | Modified Intent-to-Treat (mITT) Population was defined based in the Intent-to-Treat (ITT) population but excluded participants who did not receive the second implant after implementation of Amendment 3. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline (prior to treatment) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in IOP at Week 4 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses. | mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline (prior to treatment) to Week 4 | eyes | eyes |
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in IOP at Week 12 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. | mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline (prior to treatment) to Week 12 | eyes | eyes |
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in Intraocular Pressure (IOP) at Week 24 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. | mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline (prior to treatment) to Week 24 | eyes | eyes |
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in IOP at Weeks 8, 15, and 20 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. | ITT Population was defined as all randomized participants. Number analyzed is the number of participants and eyes analyzed at the given timepoint. | Posted | Mean | Standard Deviation | mmHg | Baseline (prior to treatment) to Weeks 8, 15 and 20 | eyes | eyes |
| ||||||||||||||||||||||||||||
| Secondary | Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator | Median time in days from first treatment to the initial use of non-study IOP-lowering treatment. | ITT Population was defined as all randomized participants. Overall number analyzed are number of participants and eyes with data available for analyses. | Posted | Median | 95% Confidence Interval | days | First treatment to end of study (up to 525 days) | eyes | eyes |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3. | ITT Population was defined as all randomized participants. Number analyzed is number of participants and eyes analyzed at the given timepoint. | Posted | Number | percentage of participants | Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20 | eyes | eyes |
|
First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
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 | SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) | Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later. | 0 | 72 | 11 | 72 | 56 | 72 |
| EG001 | Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) | Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. | 0 | 72 | 6 | 70 | 44 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Corneal endothelial cell loss | Eye disorders | MedDRA 23.1 | Systematic Assessment | 4 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=0, Contralateral Eye=4); 1 adverse event occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=1, Contralateral Eye=0). |
|
| Cataract | Eye disorders | MedDRA 23.1 | Systematic Assessment | 1 adverse event occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=0, Contralateral Eye=1). |
|
| Corneal oedema | Eye disorders | MedDRA 23.1 | Systematic Assessment | 2 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=2, Contralateral Eye=0). |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Quadrantanopia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | 1 adverse event occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=0, Contralateral Eye=1). |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal haematoma | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 23.1 | Systematic Assessment | 48 adverse events occurred in SLT (Primary Eye)/Bim SR 15 µg (Contralateral Eye) Arm:(Primary Eye=20,Contralateral Eye=28);27 adverse events occurred in Bim SR 15 µg(Primary Eye)/SLT (Contralateral Eye) Arm (Primary Eye=19, Contralateral Eye=8). |
|
| Corneal endothelial cell loss | Eye disorders | MedDRA 23.1 | Systematic Assessment | 11 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=10); 4 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=3, Contralateral Eye=1). |
|
| Punctate keratitis | Eye disorders | MedDRA 23.1 | Systematic Assessment | 18 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=8, Contralateral Eye=10);14 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=8, Contralateral Eye=6). |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 23.1 | Systematic Assessment | 8 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=7); 7 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=5, Contralateral Eye=2). |
|
| Corneal oedema | Eye disorders | MedDRA 23.1 | Systematic Assessment | 6 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=5); 9 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=8, Contralateral Eye=1). |
|
| Photophobia | Eye disorders | MedDRA 23.1 | Systematic Assessment | 8 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=2, Contralateral Eye=6); 6 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=4, Contralateral Eye=2). |
|
| Eye irritation | Eye disorders | MedDRA 23.1 | Systematic Assessment | 10 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=4, Contralateral Eye=6); 5 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=3, Contralateral Eye=2). |
|
| Eye pain | Eye disorders | MedDRA 23.1 | Systematic Assessment | 6 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=4, Contralateral Eye=2); 10 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=7, Contralateral Eye=3). |
|
| Dry eye | Eye disorders | MedDRA 23.1 | Systematic Assessment | 8 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=4, Contralateral Eye=4); 4 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=3, Contralateral Eye=1). |
|
| Anterior chamber cell | Eye disorders | MedDRA 23.1 | Systematic Assessment | 5 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=4); 3 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=2, Contralateral Eye=1). |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA 23.1 | Systematic Assessment | 5 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=4); 3 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=3, Contralateral Eye=0). |
|
| Corneal opacity | Eye disorders | MedDRA 23.1 | Systematic Assessment | 4 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=3). |
|
| Conjunctivitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment | 4 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=0, Contralateral Eye=4); 2 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=1, Contralateral Eye=1). |
|
| Sinusitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 23.1 | Systematic Assessment | 18 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=8, Contralateral Eye=10);12 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=6, Contralateral Eye=6). |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | 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 | Oct 2, 2020 | Jan 25, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Not Reported |
|
| Non-Hispanic |
|
| Not Reported |
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
| Units | Counts |
|---|
| Participants |
|
| eyes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|