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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002131-18 | EudraCT Number |
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This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye) | Experimental | Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). |
|
| Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye) | Experimental | Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). |
|
| Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye) | Experimental | Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost SR | Drug | Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure at Week 4 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | Baseline and Week 4 |
| Change From Baseline in Intraocular Pressure at Week 12 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | Baseline and Week 12 |
| Change From Baseline in Intraocular Pressure at Week 24 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Initial Use of Non-study IOP-lowering Treatment | The time from the date of initial treatment to the date date of first use of non-study IOP-lowering treatment (rescue) was analyzed using the Kaplan-Meier method. If a participant did not use any non-study IOP-lowering treatment in an eye, then the event (initial use of non-study IOP-lowering treatment) time was censored at the study exit date or the last visit date if the study exit date was not available. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Research Group /ID# 234598 | Dothan | Alabama | 36301 | United States | ||
| Arizona Advanced Eye Research Institute /ID# 234947 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39800203 | Derived | Kolko M, Tatham AJ, Lim KS, Wells AP, Shiu M, Uy HS, Sarkisian SR Jr, Ho Q, Jiao J, Kim K, Goodkin ML, Bejanian M, Robinson MR, Paauw JD; ATHENA STUDY GROUP. Phase 3, Randomized, Comparison Study of Intracameral Bimatoprost Implant 10 microg and Selective Laser Trabeculoplasty. Am J Ophthalmol. 2025 Apr;272:19-37. doi: 10.1016/j.ajo.2024.12.026. Epub 2025 Jan 10. | |
| 35943114 |
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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, analyses plans, 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 visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
The primary eye was randomized to receive either bimatoprost sustained release (SR) or selective laser trabeculoplasty (SLT) using a 1:1 ratio. If the primary eye received bimatoprost SR, the contralateral eye received SLT. If the primary eye received SLT, the contralateral eye received bimatoprost SR.
Participants were randomized at 61 sites in 11 countries (Australia, Canada, Germany, Denmark, France, Great Britain, Israel, New Zealand, Philippines, Poland, and the US).
The eye with the higher intraocular pressure (IOP) at Baseline was assigned as the primary eye. If Baseline IOP was the same in both eyes, the right eye was the primary eye.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye) | Participants enrolled prior to implementation of Protocol Amendment 3 (August 2018) received the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2021 | Mar 18, 2024 |
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|
| Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye) | Experimental | Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met. |
|
|
| Sham Bimatoprost SR | Drug | Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber. |
|
| Selective Laser Trabeculoplasty | Procedure | SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method. |
|
| Sham Selective Laser Trabeculoplasty | Procedure | Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state. |
|
| From first administration of study treatment to the end of study; overall median follow-up time of 728 days. |
| Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. For by-cycle analyses, cycle number refers to the administration cycle for bimatoprost SR, or sham bimatoprost SR administration in SLT-treated eyes. For SLT-treated eyes cycle number does not refer to SLT administrations, because SLT was only performed once (Day 1). The Day/Week number refers to the number of days/weeks after bimatoprost SR/sham bimatoprost SR administration. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | Baseline, Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24 |
| Change From Baseline in IOP at Weeks 8, 15, and 20 | IOP was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | Baseline and Weeks 8, 15, and 20 |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Arizona Glaucoma Specialists /ID# 235066 | Phoenix | Arizona | 85050-4265 | United States |
| M&M Eye Institute /ID# 235391 | Prescott | Arizona | 86301 | United States |
| Walman Eye Center /ID# 236054 | Sun City | Arizona | 85351 | United States |
| California Center for Clin Res /ID# 237412 | Arcadia | California | 91007 | United States |
| Orange County Ophthalmology /ID# 235995 | Garden Grove | California | 92843 | United States |
| Speciality Eye Care Medical Group /ID# 236001 | Glendale | California | 91203 | United States |
| Lugene Eye Institute /ID# 237042 | Glendale | California | 91204 | United States |
| Lakeside Vision Center /ID# 234971 | Irvine | California | 92604 | United States |
| California Eye Specialists Medical Group Inc. /ID# 235999 | Pasadena | California | 91107 | United States |
| North Bay Eye Associates Inc. /ID# 235429 | Petaluma | California | 94954-2387 | United States |
| Pacific Eye Associates /ID# 235326 | San Francisco | California | 94115 | United States |
| Wolstan & Goldberg Eye Associates /ID# 235166 | Torrance | California | 90505 | United States |
| Segal Drug Trials Inc. /ID# 235169 | Delray Beach | Florida | 33484 | United States |
| Eye Associates of South West Florida /ID# 235424 | Fort Myers | Florida | 33901-9311 | United States |
| Levenson Eye Associates Inc. /ID# 235021 | Jacksonville | Florida | 32204 | United States |
| University of Florida /ID# 236876 | Jacksonville | Florida | 32209 | United States |
| Ocala Eye PA /ID# 235431 | Ocala | Florida | 34474 | United States |
| Dr. Andrew Gardner Logan, FL /ID# 236946 | Tamarac | Florida | 33321 | United States |
| University of South Florida /ID# 237737 | Tampa | Florida | 33612 | United States |
| Clayton Eye Clinical Research, LLC /ID# 236678 | Morrow | Georgia | 30260-4180 | United States |
| University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875 | Chicago | Illinois | 60612 | United States |
| Sabates Eye Centers /ID# 234868 | Leawood | Kansas | 66211 | United States |
| Cincinnati Eye Institute- Edgewood /ID# 236714 | Edgewood | Kentucky | 41017-3415 | United States |
| The Eye Care Institute /ID# 236690 | Louisville | Kentucky | 40206-1738 | United States |
| Advanced Glaucoma Specialists /ID# 234799 | Reading | Massachusetts | 01867 | United States |
| Fraser Eye Center /ID# 235791 | Fraser | Michigan | 48026 | United States |
| Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879 | Chesterfield | Missouri | 63017 | United States |
| Northern New Jersey Eye Institute PA /ID# 234944 | South Orange | New Jersey | 07079-1855 | United States |
| Eye Associates of New Mexico /ID# 235115 | Albuquerque | New Mexico | 87109 | United States |
| Albemarle Clinical Trials LLC /ID# 235144 | Elizabeth City | North Carolina | 27909 | United States |
| Duplicate_Cornerstone Eye Care /ID# 235047 | High Point | North Carolina | 27262 | United States |
| Bagan Strinden Vision /ID# 234898 | Fargo | North Dakota | 58103 | United States |
| Oklahoma Eye Surgeons /ID# 235848 | Oklahoma City | Oklahoma | 73112 | United States |
| Scott and Christie and Associates /ID# 234594 | Cranberry Township | Pennsylvania | 16066 | United States |
| Eye Care Specialists /ID# 235129 | Kingston | Pennsylvania | 18704 | United States |
| Family Eye Group P.C. /ID# 236114 | Lancaster | Pennsylvania | 17601-2644 | United States |
| Wills Eye Hospital /ID# 236487 | Philadelphia | Pennsylvania | 19107 | United States |
| Carolinas Centers for Sight,PC /ID# 237017 | Florence | South Carolina | 29501 | United States |
| Chattanooga Eye Institute /ID# 235250 | Chattanooga | Tennessee | 37411 | United States |
| ATX Clinical Trials Inc. dba Keystone Research /ID# 235869 | Austin | Texas | 78731 | United States |
| Cross Eye Center /ID# 236116 | Bellaire | Texas | 77401 | United States |
| Houston Eye Associates /ID# 237883 | Houston | Texas | 77025 | United States |
| Baylor College of Medicine - Baylor Medical Center /ID# 237148 | Houston | Texas | 77030-3411 | United States |
| San Antonio Eye Center /ID# 235632 | San Antonio | Texas | 78215 | United States |
| Eye associates /ID# 236501 | San Antonio | Texas | 78229 | United States |
| Medical Center Ophthalmology Associates /ID# 235016 | San Antonio | Texas | 78240-1502 | United States |
| Emerson Clinical Research Institute /ID# 235977 | Falls Church | Virginia | 22046 | United States |
| Piedmont Eye Center /ID# 234533 | Lynchburg | Virginia | 24502 | United States |
| West Virginia University Eye Institute /ID# 235174 | Morgantown | West Virginia | 26501 | United States |
| Queensland Eye Institute /ID# 236074 | South Brisbane | Queensland | 4101 | Australia |
| Eye Surgery Associates /ID# 235872 | East Melbourne | Victoria | 3002 | Australia |
| Melbourne Eye Specialists /ID# 234614 | Fitzroy | Victoria | VIC3065 | Australia |
| Waverley Eye Clinic /ID# 234997 | Glen Waverley | Victoria | 3150 | Australia |
| The Lions Eye Institute /ID# 236832 | Nedlands | Western Australia | 6009 | Australia |
| Essendon Eye Clinic /ID# 235433 | Essendon | 3040 | Australia |
| Geelong Eye Clinic /ID# 236118 | Geelong | 3220 | Australia |
| Vision Eye Institute /ID# 236003 | Melbourne | 3058 | Australia |
| Ophthalmology Clinic Bellevue /ID# 234631 | Montreal | Quebec | H1V 1G5 | Canada |
| Rigshospitalet Glostrup /ID# 237709 | Glostrup Municipality | Capital Region | 2600 | Denmark |
| Chu Angers /Id# 237805 | Angers | 49933 | France |
| Polyclinique de la Baie /ID# 235842 | Avranches | 50300 | France |
| CHU Bordeaux - Hopital Pellegrin /ID# 237705 | Bordeaux | 33000 | France |
| Clinique Honore Cave - Pharmacie /ID# 235925 | Montauban | 82000 | France |
| CHU de Nice - Hospital Pasteur 2 /ID# 235844 | Nice | 06000 | France |
| CHU Strasbourg - Hopital Civil /ID# 237837 | Strasbourg | 67091 | France |
| Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841 | Toulouse | 31000 | France |
| Internationale Innovative Ophthalmochirurgie /ID# 235263 | Düsseldorf | North Rhine-Westphalia | 40212 | Germany |
| Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966 | Berlin | 13353 | Germany |
| Universitaetsklinikum Magdeburg /ID# 237284 | Magdeburg | 39120 | Germany |
| Tel Aviv Sourasky Medical Center /ID# 237211 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Rambam Health Care Campus /ID# 237741 | Haifa | 3109601 | Israel |
| The Lady Davis Carmel Medical Center /ID# 236757 | Haifa | 34362 | Israel |
| Galilee Medical Center /ID# 235742 | Nahariya | 2210001 | Israel |
| Rabin Medical Center /ID# 237698 | Petah Tikva | 4941492 | Israel |
| Auckland Eye Hospital /ID# 235253 | Remuera | Auckland | 1050 | New Zealand |
| Southern Eye Specialists /ID# 236081 | Christchurch | Canterbury | 8013 | New Zealand |
| Capital Eye Specialists /ID# 236111 | Wellington | 6011 | New Zealand |
| Asian Eye Institute /ID# 235092 | Makati City | 1200 | Philippines |
| Peregrine Eye and Laser Institute /ID# 236220 | Makati City | 1209 | Philippines |
| American Eye Center /ID# 235320 | Makati City | 1229 | Philippines |
| Cardinal Santos Medical Center /ID# 235325 | San Juan City | 1502 | Philippines |
| Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235929 | Olsztyn | 10-424 | Poland |
| Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041 | Omsk | 644024 | Russia |
| Samara State Medical University /ID# 236997 | Samara | 443099 | Russia |
| University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129 | Derby | Derbyshire | DE22 3NE | United Kingdom |
| Queen Mary's Hospital /ID# 234899 | Greater London | Kent | DA14 6LT | United Kingdom |
| Guys and St Thomas NHS Foundation Trust /ID# 236806 | London | London, City of | SE1 9RT | United Kingdom |
| Epsom & St Helier University Hospital NHS Trust /ID# 236902 | Carshalton | Surrey | SM5 1AA | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust /ID# 238315 | Cambridge | CB2 0QQ | United Kingdom |
| NHS Lothian /ID# 237450 | Edinburgh | EH3 9HE | United Kingdom |
| Moorfields Eye Hospital NHS Foundation Trust /ID# 237708 | London | EC1V 2PD | United Kingdom |
| Imperial College Healthcare NHS Trust /ID# 234777 | London | W2 1NY | United Kingdom |
| Manchester University NHS Foundation Trust /ID# 237318 | Manchester | M13 9WL | United Kingdom |
| 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. |
| FG001 | Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye) | Participants enrolled prior to implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). |
| FG002 | Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye) | Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met. |
| FG003 | Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye) | Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met. |
| Received Treatment | Participants are counted as treated if either eye received study treatment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 μg (Contralateral Eye) | Participants enrolled prior to implementation of Protocol Amendment 3 (August 2018) received the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). |
| BG001 | Stage 1: Bimatoprost SR 15 μg (Primary Eye) / SLT Contralateral Eye) | Participants enrolled prior to implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). |
| BG002 | Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 μg (Contralateral Eye) | Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met. |
| BG003 | Stage 2: Bimatoprost SR 10 μg (Primary Eye) / SLT (Contralateral Eye) | Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met. |
| BG004 | 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 | Demographic data were analyzed separately for participants in Stage 1 and Stage 2. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Intraocular Pressure at Week 4 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | The intent-to-treat (ITT) population is defined as all randomized participants. Primary efficacy analysis was performed for participants enrolled in Stage 2. Overall Number of Participants / Units Analyzed reflects the number of participants and eyes with data available for the analysis. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 4 | Eyes | Eyes |
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| Primary | Change From Baseline in Intraocular Pressure at Week 12 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | The ITT population is defined as all randomized participants. Primary efficacy analysis was performed for participants enrolled in Stage 2. Overall Number of Participants / Units Analyzed reflects the number of participants and eyes with data available for the analysis. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 12 | Eyes | Eyes |
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| Primary | Change From Baseline in Intraocular Pressure at Week 24 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | The ITT population is defined as all randomized participants. Primary efficacy analysis was performed for participants enrolled in Stage 2. Overall Number of Participants / Units Analyzed reflects the number of participants and eyes with data available for the analysis. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24 | Eyes | Eyes |
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| Secondary | Time to Initial Use of Non-study IOP-lowering Treatment | The time from the date of initial treatment to the date date of first use of non-study IOP-lowering treatment (rescue) was analyzed using the Kaplan-Meier method. If a participant did not use any non-study IOP-lowering treatment in an eye, then the event (initial use of non-study IOP-lowering treatment) time was censored at the study exit date or the last visit date if the study exit date was not available. | Participants in the ITT population enrolled in Stage 2; eyes that received study treatment are included in the analysis. | Posted | Number | 95% Confidence Interval | days | From first administration of study treatment to the end of study; overall median follow-up time of 728 days. | Eyes | Eyes |
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| Secondary | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. For by-cycle analyses, cycle number refers to the administration cycle for bimatoprost SR, or sham bimatoprost SR administration in SLT-treated eyes. For SLT-treated eyes cycle number does not refer to SLT administrations, because SLT was only performed once (Day 1). The Day/Week number refers to the number of days/weeks after bimatoprost SR/sham bimatoprost SR administration. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | Participants/eyes enrolled in Stage 2 with available IOP data at Baseline and each time point; participants who received retreatment with bimatoprost SR/sham bimatoprost SR at or after Week 16 are not included in Cycle 1 time points from the date of retreatment. | Posted | Number | percentage of eyes | Baseline, Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24 | Eyes | Eyes |
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| Secondary | Change From Baseline in IOP at Weeks 8, 15, and 20 | IOP was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. | Intent-to-treat poulation participants enrolled in Stage 2 with available IOP data at each time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Weeks 8, 15, and 20 | Eyes | Eyes |
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All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
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 | Stage 1: SLT | Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). | 0 | 57 | 3 | 56 | 41 | 56 |
| EG001 | Stage 1: Bimatoprost SR 15 µg | Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). | 0 | 57 | 3 | 55 | 49 | 55 |
| EG002 | Stage 2: SLT | SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). Sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met. | 2 | 183 | 18 | 180 | 107 | 180 |
| EG003 | Stage 2: Bimatoprost SR 10 µg | Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). Bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met. | 2 | 183 | 22 | 175 | 121 | 175 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| CATARACT SUBCAPSULAR | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| CORNEAL ENDOTHELIAL CELL LOSS | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| CORNEAL OEDEMA | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| CORNEAL THICKENING | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| EPISCLERITIS | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| PHOTOPHOBIA | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| RETINAL VEIN OCCLUSION | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
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| BURSITIS INFECTIVE | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| CERVICAL SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| OESOPHAGEAL CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| PROSTATE CANCER STAGE I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| APHASIA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| MYELOPATHY | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| VOCAL CORD DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| ACCELERATED HYPERTENSION | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANTERIOR CHAMBER CELL | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| ANTERIOR CHAMBER FLARE | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| BLEPHARITIS | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| CONJUNCTIVAL HAEMORRHAGE | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| CONJUNCTIVAL HYPERAEMIA | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| CORNEAL ENDOTHELIAL CELL LOSS | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| CORNEAL TOUCH | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| DRY EYE | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| EYE IRRITATION | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| EYE PAIN | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| FOREIGN BODY SENSATION IN EYES | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| IRITIS | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| LACRIMATION INCREASED | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| PHOTOPHOBIA | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| PUNCTATE KERATITIS | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| VISUAL FIELD DEFECT | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| VITREOUS FLOATERS | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| CONJUNCTIVITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment | ocular event |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment | ocular event |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment | Stage 1 arms = ocular event |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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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 10, 2022 | Mar 18, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
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