A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
2 other identifiers
interventional
144
9 countries
33
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2016
Longer than P75 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedStudy Start
First participant enrolled
February 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2021
CompletedResults Posted
Study results publicly available
February 23, 2022
CompletedFebruary 23, 2022
February 1, 2022
4.9 years
December 10, 2015
January 25, 2022
February 22, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (3)
Change From Baseline in IOP at Weeks 8, 15, and 20
Baseline (prior to treatment) to Weeks 8, 15 and 20
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
First treatment to end of study (up to 525 days)
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
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
Study Arms (2)
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
ACTIVE COMPARATORPrimary 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)
EXPERIMENTALPrimary 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.
Interventions
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).
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 administered on Day 1.
Sham Selective Laser Trabeculoplasty administered on Day 1.
Eligibility Criteria
You may qualify if:
- \- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
You may not qualify if:
- Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
- Enrollment in other studies using Bimatoprost SR.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (33)
Eye Center South
Dothan, Alabama, 36301, United States
Arizona Eye Center
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
Related Publications (1)
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.
PMID: 35943114DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
Margot Goodkin
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 22, 2015
Study Start
February 24, 2016
Primary Completion
January 26, 2021
Study Completion
January 26, 2021
Last Updated
February 23, 2022
Results First Posted
February 23, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- Access Criteria
- 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.
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.