Back to resultsComparison 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, Open-Angle
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
Exclusion Criteria:
Exclusion Criteria:
- Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
- Previous use of commercially available Bimatoprost SR; c oncurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.
Sites / Locations
- Trinity Research Group /ID# 234598
- Arizona Advanced Eye Research Institute /ID# 234947
- Arizona Glaucoma Specialists /ID# 235066
- M&M Eye Institute /ID# 235391
- Walman Eye Center /ID# 236054
- California Center for Clin Res /ID# 237412
- Orange County Ophthalmology /ID# 235995
- Speciality Eye Care Medical Group /ID# 236001
- Lugene Eye Institute /ID# 237042
- Lakeside Vision Center /ID# 234971
- California Eye Specialists Medical Group Inc. /ID# 235999
- North Bay Eye Associates Inc. /ID# 235429
- Pacific Eye Associates /ID# 235326
- Wolstan & Goldberg Eye Associates /ID# 235166
- Segal Drug Trials Inc. /ID# 235169
- Eye Associates of South West Florida /ID# 235424
- Levenson Eye Associates Inc. /ID# 235021
- University of Florida /ID# 236876
- Ocala Eye PA /ID# 235431
- Dr. Andrew Gardner Logan, FL /ID# 236946
- University of South Florida /ID# 237737
- Clayton Eye Clinical Research, LLC /ID# 236678
- University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875
- Sabates Eye Centers /ID# 234868
- Cincinnati Eye Institute- Edgewood /ID# 236714
- The Eye Care Institute /ID# 236690
- Advanced Glaucoma Specialists /ID# 234799
- Fraser Eye Center /ID# 235791
- Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879
- Northern New Jersey Eye Institute PA /ID# 234944
- Eye Associates of New Mexico /ID# 235115
- Albemarle Clinical Trials LLC /ID# 235144
- Duplicate_Cornerstone Eye Care /ID# 235047
- Bagan Strinden Vision /ID# 234898
- Oklahoma Eye Surgeons /ID# 235848
- Scott and Christie and Associates /ID# 234594
- Eye Care Specialists /ID# 235129
- Family Eye Group P.C. /ID# 236114
- Wills Eye Hospital /ID# 236487
- Carolinas Centers for Sight,PC /ID# 237017
- Chattanooga Eye Institute /ID# 235250
- ATX Clinical Trials Inc. dba Keystone Research /ID# 235869
- Cross Eye Center /ID# 236116
- Houston Eye Associates /ID# 237883
- Baylor College of Medicine - Baylor Medical Center /ID# 237148
- San Antonio Eye Center /ID# 235632
- Eye associates /ID# 236501
- Medical Center Ophthalmology Associates /ID# 235016
- Emerson Clinical Research Institute /ID# 235977
- Piedmont Eye Center /ID# 234533
- West Virginia University Eye Institute /ID# 235174
- Queensland Eye Institute /ID# 236074
- Eye Surgery Associates /ID# 235872
- Melbourne Eye Specialists /ID# 234614
- Waverley Eye Clinic /ID# 234997
- The Lions Eye Institute /ID# 236832
- Essendon Eye Clinic /ID# 235433
- Geelong Eye Clinic /ID# 236118
- Vision Eye Institute /ID# 236003
- Ophthalmology Clinic Bellevue /ID# 234631
- Rigshospitalet Glostrup /ID# 237709
- Chu Angers /Id# 237805
- Polyclinique de la Baie /ID# 235842
- CHU Bordeaux - Hopital Pellegrin /ID# 237705
- Clinique Honore Cave - Pharmacie /ID# 235925
- CHU de Nice - Hospital Pasteur 2 /ID# 235844
- CHU Strasbourg - Hopital Civil /ID# 237837
- Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841
- Internationale Innovative Ophthalmochirurgie /ID# 235263
- Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966
- Universitaetsklinikum Magdeburg /ID# 237284
- Tel Aviv Sourasky Medical Center /ID# 237211
- Rambam Health Care Campus /ID# 237741
- The Lady Davis Carmel Medical Center /ID# 236757
- Galilee Medical Center /ID# 235742
- Rabin Medical Center /ID# 237698
- Auckland Eye Hospital /ID# 235253
- Southern Eye Specialists /ID# 236081
- Capital Eye Specialists /ID# 236111
- Asian Eye Institute /ID# 235092
- Peregrine Eye and Laser Institute /ID# 236220
- American Eye Center /ID# 235320
- Cardinal Santos Medical Center /ID# 235325
- Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235929
- Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041
- Samara State Medical University /ID# 236997
- University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129
- Queen Mary's Hospital /ID# 234899
- Guys and St Thomas NHS Foundation Trust /ID# 236806
- Epsom & St Helier University Hospital NHS Trust /ID# 236902
- Cambridge University Hospitals NHS Foundation Trust /ID# 238315
- NHS Lothian /ID# 237450
- Moorfields Eye Hospital NHS Foundation Trust /ID# 237708
- Imperial College Healthcare NHS Trust /ID# 234777
- Manchester University NHS Foundation Trust /ID# 237318
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bimatoprost Sustained-Release (SR)
Selective Laser Trabeculoplasty (SLT)
Arm Description
Assigned Primary Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
Assigned Primary Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
Outcomes
Primary Outcome Measures
Change from Baseline in IOP at Week 4
Change from Baseline in IOP at Week 12
Change from Baseline in Intraocular Pressure (IOP) at Week 24
Secondary Outcome Measures
IOP change from baseline at Week 8
IOP change from baseline at Week 15
IOP change from baseline at Week 20
Time to initial use of nonstudy IOP-lowering treatment as determined by the investigator
Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 4
Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 12
Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 24
Percentage of SLT eyes achieving ≥ 20% reduction at Week 4
Percentage of SLT eyes achieving ≥ 20% reduction at Week 12
Percentage of SLT eyes achieving ≥ 20% reduction at Week 24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02507687
Brief Title
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
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 27, 2015 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the intraocular pressure-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.
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 ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost Sustained-Release (SR)
Arm Type
Experimental
Arm Description
Assigned Primary Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
Arm Title
Selective Laser Trabeculoplasty (SLT)
Arm Type
Active Comparator
Arm Description
Assigned Primary Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
Intervention Type
Drug
Intervention Name(s)
Bimatoprost SR
Intervention Description
Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
Intervention Type
Drug
Intervention Name(s)
Sham Bimatoprost SR
Intervention Description
Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
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
Change from Baseline in IOP at Week 4
Time Frame
Baseline, Week 4
Title
Change from Baseline in IOP at Week 12
Time Frame
Baseline, Week 12
Title
Change from Baseline in Intraocular Pressure (IOP) at Week 24
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
IOP change from baseline at Week 8
Time Frame
Baseline, Week 8
Title
IOP change from baseline at Week 15
Time Frame
Baseline, Week 15
Title
IOP change from baseline at Week 20
Time Frame
Baseline, Week 20
Title
Time to initial use of nonstudy IOP-lowering treatment as determined by the investigator
Time Frame
Baseline, Month 24
Title
Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 4
Time Frame
Baseline, Week 4
Title
Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 12
Time Frame
Baseline, Week 12
Title
Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 24
Time Frame
Baseline, Week 24
Title
Percentage of SLT eyes achieving ≥ 20% reduction at Week 4
Time Frame
Baseline, Week 4
Title
Percentage of SLT eyes achieving ≥ 20% reduction at Week 12
Time Frame
Baseline, Week 12
Title
Percentage of SLT eyes achieving ≥ 20% reduction at Week 24
Time Frame
Baseline, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
Exclusion Criteria:
Exclusion Criteria:
Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Trinity Research Group /ID# 234598
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Arizona Advanced Eye Research Institute /ID# 234947
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Glaucoma Specialists /ID# 235066
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050-4265
Country
United States
Facility Name
M&M Eye Institute /ID# 235391
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
Walman Eye Center /ID# 236054
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
California Center for Clin Res /ID# 237412
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Orange County Ophthalmology /ID# 235995
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Speciality Eye Care Medical Group /ID# 236001
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
Lugene Eye Institute /ID# 237042
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Lakeside Vision Center /ID# 234971
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Facility Name
California Eye Specialists Medical Group Inc. /ID# 235999
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
North Bay Eye Associates Inc. /ID# 235429
City
Petaluma
State/Province
California
ZIP/Postal Code
94954-2387
Country
United States
Facility Name
Pacific Eye Associates /ID# 235326
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates /ID# 235166
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Segal Drug Trials Inc. /ID# 235169
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Eye Associates of South West Florida /ID# 235424
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-9311
Country
United States
Facility Name
Levenson Eye Associates Inc. /ID# 235021
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
University of Florida /ID# 236876
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Ocala Eye PA /ID# 235431
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Dr. Andrew Gardner Logan, FL /ID# 236946
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
University of South Florida /ID# 237737
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC /ID# 236678
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260-4180
Country
United States
Facility Name
University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Sabates Eye Centers /ID# 234868
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Cincinnati Eye Institute- Edgewood /ID# 236714
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017-3415
Country
United States
Facility Name
The Eye Care Institute /ID# 236690
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206-1738
Country
United States
Facility Name
Advanced Glaucoma Specialists /ID# 234799
City
Reading
State/Province
Massachusetts
ZIP/Postal Code
01867
Country
United States
Facility Name
Fraser Eye Center /ID# 235791
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Facility Name
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Northern New Jersey Eye Institute PA /ID# 234944
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079-1855
Country
United States
Facility Name
Eye Associates of New Mexico /ID# 235115
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Albemarle Clinical Trials LLC /ID# 235144
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
Facility Name
Duplicate_Cornerstone Eye Care /ID# 235047
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Bagan Strinden Vision /ID# 234898
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Oklahoma Eye Surgeons /ID# 235848
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Scott and Christie and Associates /ID# 234594
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Eye Care Specialists /ID# 235129
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Family Eye Group P.C. /ID# 236114
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601-2644
Country
United States
Facility Name
Wills Eye Hospital /ID# 236487
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Carolinas Centers for Sight,PC /ID# 237017
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Chattanooga Eye Institute /ID# 235250
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
ATX Clinical Trials Inc. dba Keystone Research /ID# 235869
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Cross Eye Center /ID# 236116
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Houston Eye Associates /ID# 237883
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 237148
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
San Antonio Eye Center /ID# 235632
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Eye associates /ID# 236501
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical Center Ophthalmology Associates /ID# 235016
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1502
Country
United States
Facility Name
Emerson Clinical Research Institute /ID# 235977
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
Piedmont Eye Center /ID# 234533
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
West Virginia University Eye Institute /ID# 235174
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States
Facility Name
Queensland Eye Institute /ID# 236074
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Eye Surgery Associates /ID# 235872
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Melbourne Eye Specialists /ID# 234614
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
VIC3065
Country
Australia
Facility Name
Waverley Eye Clinic /ID# 234997
City
Glen Waverley
State/Province
Victoria
ZIP/Postal Code
3150
Country
Australia
Facility Name
The Lions Eye Institute /ID# 236832
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Essendon Eye Clinic /ID# 235433
City
Essendon
ZIP/Postal Code
3040
Country
Australia
Facility Name
Geelong Eye Clinic /ID# 236118
City
Geelong
ZIP/Postal Code
3220
Country
Australia
Facility Name
Vision Eye Institute /ID# 236003
City
Melbourne
ZIP/Postal Code
3058
Country
Australia
Facility Name
Ophthalmology Clinic Bellevue /ID# 234631
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1V 1G5
Country
Canada
Facility Name
Rigshospitalet Glostrup /ID# 237709
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Chu Angers /Id# 237805
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Polyclinique de la Baie /ID# 235842
City
Avranches
ZIP/Postal Code
50300
Country
France
Facility Name
CHU Bordeaux - Hopital Pellegrin /ID# 237705
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Clinique Honore Cave - Pharmacie /ID# 235925
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
CHU de Nice - Hospital Pasteur 2 /ID# 235844
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
CHU Strasbourg - Hopital Civil /ID# 237837
City
Strasbourg cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Internationale Innovative Ophthalmochirurgie /ID# 235263
City
Dusseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40212
Country
Germany
Facility Name
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg /ID# 237284
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Tel Aviv Sourasky Medical Center /ID# 237211
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 237741
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
The Lady Davis Carmel Medical Center /ID# 236757
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Galilee Medical Center /ID# 235742
City
Naharia
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Rabin Medical Center /ID# 237698
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Auckland Eye Hospital /ID# 235253
City
Remuera
State/Province
Auckland
ZIP/Postal Code
1050
Country
New Zealand
Facility Name
Southern Eye Specialists /ID# 236081
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Capital Eye Specialists /ID# 236111
City
Wellington
ZIP/Postal Code
6011
Country
New Zealand
Facility Name
Asian Eye Institute /ID# 235092
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Peregrine Eye and Laser Institute /ID# 236220
City
Makati City
ZIP/Postal Code
1209
Country
Philippines
Facility Name
American Eye Center /ID# 235320
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Cardinal Santos Medical Center /ID# 235325
City
San Juan City
ZIP/Postal Code
1502
Country
Philippines
Facility Name
Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235929
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
Facility Name
Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
Samara State Medical University /ID# 236997
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Facility Name
University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Queen Mary's Hospital /ID# 234899
City
Greater London
State/Province
Kent
ZIP/Postal Code
DA14 6LT
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 236806
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Epsom & St Helier University Hospital NHS Trust /ID# 236902
City
Carshalton
State/Province
Surrey
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust /ID# 238315
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
NHS Lothian /ID# 237450
City
Edinburgh
ZIP/Postal Code
EH3 9HE
Country
United Kingdom
Facility Name
Moorfields Eye Hospital NHS Foundation Trust /ID# 237708
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust /ID# 234777
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust /ID# 237318
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
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, 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 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/
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
http://allerganclinicaltrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@allergan.com for assistance.
Learn more about this trial
Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
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