Back to resultsA Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Open-Angle Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimatoprost SR
Sham Bimatoprost SR
Selective Laser Trabeculoplasty
Sham Selective Laser Trabeculoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
Exclusion Criteria:
- Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
- Enrollment in other studies using Bimatoprost SR.
Sites / Locations
- Eye Center South
- Arizona Eye Center
- Walman Eye Center
- Shasta Eye Medical Group, Inc.
- Wolstan & Goldberg Eye Associates
- Eye Associates of Colorado Springs
- West Coast Eye Institute
- Emory University Eye Center
- Coastal Research Associates, LLC
- The Eye Care Institute
- Fraser Eye Center
- Galanis Cataract and Laser Eye Center
- Ophthalmic Consultants of Long Island
- Asheville Eye Associates
- James D. Branch MD
- Bergstrom Eye Research, LLC
- Scott & Christie and Associates, PC
- The Cataract & Glaucoma Center
- DCT- Shah Research
- San Antonio Eye Center
- Vistar Eye Center
- Marsden Eye Specialists
- Glostrup Hospital
- CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie
- Prywatna Klinika Okulistyczna OFTALMIKA
- Centrum Diagnostykii Mikrochirurgii Oka LENS ul.
- S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch
- Ophthalmic Clinical Hospital V.P. Vyhodtseva
- Singapore National Eye Centre
- Centro de Oftalmologia Barraquer
- Hospital Clinico San Carlos
- Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital
- Thammasat University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP) at Baseline
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02636946
Brief Title
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2016 (Actual)
Primary Completion Date
January 26, 2021 (Actual)
Study Completion Date
January 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost SR
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Sham Bimatoprost SR
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Selective Laser Trabeculoplasty
Intervention Description
Selective Laser Trabeculoplasty administered on Day 1.
Intervention Type
Procedure
Intervention Name(s)
Sham Selective Laser Trabeculoplasty
Intervention Description
Sham Selective Laser Trabeculoplasty administered on Day 1.
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) at Baseline
Description
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
Time Frame
Baseline (prior to treatment)
Title
Change From Baseline in IOP at Week 4
Description
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.
Time Frame
Baseline (prior to treatment) to Week 4
Title
Change From Baseline in IOP at Week 12
Description
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.
Time Frame
Baseline (prior to treatment) to Week 12
Title
Change From Baseline in Intraocular Pressure (IOP) at Week 24
Description
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.
Time Frame
Baseline (prior to treatment) to Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in IOP at Weeks 8, 15, and 20
Description
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.
Time Frame
Baseline (prior to treatment) to Weeks 8, 15 and 20
Title
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
Description
Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.
Time Frame
First treatment to end of study (up to 525 days)
Title
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Description
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.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
Exclusion Criteria:
Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
Enrollment in other studies using Bimatoprost SR.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margot Goodkin
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Eye Center South
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Walman Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Shasta Eye Medical Group, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96002
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Eye Associates of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
West Coast Eye Institute
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Emory University Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Coastal Research Associates, LLC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Fraser Eye Center
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Facility Name
Galanis Cataract and Laser Eye Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63119
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Asheville Eye Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
James D. Branch MD
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Bergstrom Eye Research, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
The Cataract & Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
DCT- Shah Research
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States
Facility Name
San Antonio Eye Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Vistar Eye Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Marsden Eye Specialists
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Glostrup Hospital
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Prywatna Klinika Okulistyczna OFTALMIKA
City
Bydgoszcz
State/Province
Kuyavian-Pomeranian Voivodeship
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Centrum Diagnostykii Mikrochirurgii Oka LENS ul.
City
Olsztyn
State/Province
Warmian-Masurian Voivodeship
ZIP/Postal Code
10-424
Country
Poland
Facility Name
S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch
City
Novosibirsk
ZIP/Postal Code
630071
Country
Russian Federation
Facility Name
Ophthalmic Clinical Hospital V.P. Vyhodtseva
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Centro de Oftalmologia Barraquer
City
Barcelona
ZIP/Postal Code
8021
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Thammasat University Hospital
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
35943114
Citation
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.
Results Reference
derived
Links:
URL
https://www.abbvieclinicaltrials.com/search-results/?SearchTerm=NCT02636946&Latitude=&Longitude=&LocationName=&conditions=&Status=&phases=&AgeRanges=&gender=&GenderDescriptions=&StudyTypes=&AttachmentTypes=&MileRadius=100&PageIndex=0&hasResults=&isHighValue=&SortField=&SortOrder=
Description
clinical study report synopsis
Learn more about this trial
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
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