Back to resultsEvaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimatoprost (SR)
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open-Angle Glaucoma (OAG), Ocular Hypertension (OHT), Bimatoprost
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of either Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.
Exclusion Criteria:
- Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study.
- Previous administration with Bimatoprost SR in the study eye.
Sites / Locations
- Horizon Eye Specialists & Lasik Centers /ID# 235240
- Atlantis Eye Care /ID# 235530
- Lakeside Vision Center /ID# 234970
- Global Research Foundation /ID# 237350
- The Eye Research Foundation /ID# 234521
- Byers Eye Institute Stanford /ID# 235544
- Foothill Eye Institute /ID# 235640
- Connecticut Eye Consultants P.C. /ID# 234981
- Specialty Retina Center /ID# 236045
- Segal Drug Trials, Inc /ID# 235784
- International Research Center /ID# 238050
- Thomas Eye Group PC /ID# 235737
- Indiana University - Glick Eye Institute /ID# 235886
- Midwest Eye Institute /ID# 237876
- Tulane University /ID# 237632
- Ophthalmic Consultants of Boston /ID# 236534
- Clinical Eye Research of Boston LLC /ID# 234966
- University of Michigan, Kellogg Eye Center /ID# 236496
- Fraser Eye Center /ID# 235790
- Silverstein Eye Centers /ID# 237881
- Moyes Eye Center PC /ID# 234989
- Alterman Modi & Wolter /ID# 235248
- The Ohio State University /ID# 236790
- AMA Eyes Research Institute /ID# 235542
- Dean McGee Eye Institute /ID# 236823
- Oklahoma Eye Surgeons /ID# 235849
- Drs Fine Hoffman & Sims LLC /ID# 235918
- Ophthalmic Partners, PC /ID# 235741
- Scott and Christie and Associates /ID# 234593
- Black Hills Regional Eye Institute /ID# 235075
- Vance Thompson Vision /ID# 235072
- Eye Specialty Group /ID# 235721
- Vanderbilt University Medical Center /ID# 237177
- Advancing Vision Research /ID# 236681
- ATX Clinical Trials Inc. dba Keystone Research /ID# 235868
- Medical Center Ophthalmology Associates - Keystone Research /ID# 235787
- Southern Utah Medical Research /ID# 235602
- Piedmont Eye Center /ID# 234534
- Consultorio Oftalmologico Dr. Fabian Lerner /ID# 235855
- Hospital Universitario Austral /ID# 237727
- Oftalmología Global /ID# 239187
- Hospital Italiano /ID# 235851
- Centro Privado de Ojos /ID# 241283
- Centro oftalmologico Dr Charles /ID# 235881
- Oftar Mendoza /ID# 240535
- Eye Surgery Associates /ID# 235873
- Multiprofile Hospital for Active Treatment "Lozenetz" /ID# 244053
- Medical Center Oxycom Burgas /ID# 235580
- UMHAT Sveti Georgi /ID# 237027
- MHAT Hadzhi Dimitar /ID# 238248
- MHAT Dr. Bratan Shukerov /ID# 235498
- Medical center for eye healt Focus Ltd /ID# 235575
- Pentagram Eye Hospital /Id# 235813
- Specialized Hospital for Active Treatment in Ocular Diseases "Zrenie" /ID# 235500
- Diagnostic consultative center Aleksandrovska /ID# 238105
- St. Sofia Hospital /ID# 235525
- Medical Center -Verea /ID# 235494
- Medical center Orfey /ID# 237344
- MHAT Trakia /ID# 238137
- Specialized Ophthalmological Hospital for Active Treatment - Varna /ID# 235962
- Ocni klinika Pardubice /ID# 235944
- Fakultni nemocnice Kralovske Vinohrady /ID# 234323
- Vseobecna fakultni nemocnice v Praze /ID# 234422
- Rigshospitalet Glostrup /ID# 235743
- Universitatsklinikum Freiburg /ID# 238048
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 237069
- Klinikum Dresden Friedrichstadt /ID# 235308
- Universitaetsmedizin Goettingen /ID# 237377
- Asklepios Kinik Nord - Heidberg Augenklinik /ID# 235955
- St. Franziskus-Hospital /ID# 237714
- Dietrich-Bonhoeffer-Klinikum /ID# 235262
- Universitaetsmedizin Rostock /ID# 237263
- Augenzentrum Dr Hamacher /ID# 235537
- Bugat Pal Korhaz /ID# 238144
- Markusovszky Egyetemi Oktatokorhaz /ID# 237383
- Budapest Retina Intezet /ID# 235950
- Jahn Ferenc Del-pesti Korhaz es Rendelointezet /ID# 237111
- Royal Victoria Eye and Ear Hospital /ID# 235546
- Institute of Eye Surgery /ID# 235547
- University of Catanzaro /ID# 238066
- Eye Clinic University of Catania /ID# 235573
- Ospedale Ss. Annunziata /ID# 236587
- Fondazione IRCCS Policlinico /ID# 236909
- University of Perugia /ID# 235811
- Fondazione Bietti - Ospedale Britannico /ID# 235495
- Sapienza University of Rome - Polo Pontino /ID# 237451
- Southern Eye Specialists /ID# 236080
- Capital Eye Specialists /ID# 236112
- Wojskowy Instytut Medyczny /ID# 237031
- Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 237076
- Gabinet Okulistyczny Edward Wylegala /ID# 235946
- Medical Center Julianow /ID# 235961
- Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235928
- S. Fyodorov Eye Microsurgery Federal State Institution /ID# 235984
- Pretoria Eye Institute - Private Practice /ID# 235658
- Somerset Eye Specialist Medical & Surgical Centre /ID# 235540
- Norrlands University hospital /ID# 237553
- The Princess Alexandra NHS Trust /ID# 234433
- Oxford University Hospitals NHS Foundation Trust /ID# 237282
- Cambridge University Hospitals NHS Foundation Trust /ID# 238255
- Mid Essex Hospitals NHS Trust /ID# 237776
- East Suffolk and North Essex NHS Foundation Trust /ID# 234657
- Mid-Cheshire Hospitals NHS Trust /ID# 235418
- Liverpool University Hospitals NHS Foundation Trust /ID# 237095
- Liverpool University Hospitals NHS Foundation Trust /ID# 237321
- Central Middlesex Hospital /ID# 236216
- King's College Hospital NHS Foundation Trust /ID# 237275
- York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 237683
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bimatoprost SR - Dose A
Bimatoprost SR - Dose B
Arm Description
Study Eye: Participants will receive 1 - 3 Cycles of Bimatoprost SR administrations of Dose A Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
Study Eye: Participants received 1-3 Cycles of Bimatoprost SR administrations of Dose B Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
Outcomes
Primary Outcome Measures
Retreatment or rescue administered for IOP
Treatment modality determined by investigator.
Number of patients experiencing a treatment emergent adverse event
The number of patients who experienced one or more TEAE during the 48 month treatment period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03850782
Brief Title
Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Official Title
A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
August 9, 2025 (Anticipated)
Study Completion Date
August 9, 2025 (Anticipated)
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 evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Open-Angle Glaucoma (OAG), Ocular Hypertension (OHT), Bimatoprost
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
515 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost SR - Dose A
Arm Type
Experimental
Arm Description
Study Eye: Participants will receive 1 - 3 Cycles of Bimatoprost SR administrations of Dose A
Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
Arm Title
Bimatoprost SR - Dose B
Arm Type
Experimental
Arm Description
Study Eye: Participants received 1-3 Cycles of Bimatoprost SR administrations of Dose B
Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost (SR)
Intervention Description
Study Eye: Cycles 1 - 3 administrations through the PRN treatment period.
Fellow Eye: Standard of care or Bimatoprost SR.
Primary Outcome Measure Information:
Title
Retreatment or rescue administered for IOP
Description
Treatment modality determined by investigator.
Time Frame
Up to 48 months
Title
Number of patients experiencing a treatment emergent adverse event
Description
The number of patients who experienced one or more TEAE during the 48 month treatment period.
Time Frame
Baseline up to 48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of either Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.
Exclusion Criteria:
Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study.
Previous administration with Bimatoprost SR in the study eye.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Horizon Eye Specialists & Lasik Centers /ID# 235240
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Atlantis Eye Care /ID# 235530
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Lakeside Vision Center /ID# 234970
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Facility Name
Global Research Foundation /ID# 237350
City
Los Angeles
State/Province
California
ZIP/Postal Code
90041-1718
Country
United States
Facility Name
The Eye Research Foundation /ID# 234521
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3637
Country
United States
Facility Name
Byers Eye Institute Stanford /ID# 235544
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Foothill Eye Institute /ID# 235640
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Connecticut Eye Consultants P.C. /ID# 234981
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Specialty Retina Center /ID# 236045
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Segal Drug Trials, Inc /ID# 235784
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
International Research Center /ID# 238050
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Thomas Eye Group PC /ID# 235737
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Indiana University - Glick Eye Institute /ID# 235886
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Midwest Eye Institute /ID# 237876
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Tulane University /ID# 237632
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2699
Country
United States
Facility Name
Ophthalmic Consultants of Boston /ID# 236534
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Clinical Eye Research of Boston LLC /ID# 234966
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
University of Michigan, Kellogg Eye Center /ID# 236496
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Fraser Eye Center /ID# 235790
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Facility Name
Silverstein Eye Centers /ID# 237881
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64034
Country
United States
Facility Name
Moyes Eye Center PC /ID# 234989
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Alterman Modi & Wolter /ID# 235248
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603-2455
Country
United States
Facility Name
The Ohio State University /ID# 236790
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1257
Country
United States
Facility Name
AMA Eyes Research Institute /ID# 235542
City
Marysville
State/Province
Ohio
ZIP/Postal Code
43040
Country
United States
Facility Name
Dean McGee Eye Institute /ID# 236823
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Eye Surgeons /ID# 235849
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Drs Fine Hoffman & Sims LLC /ID# 235918
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Ophthalmic Partners, PC /ID# 235741
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Scott and Christie and Associates /ID# 234593
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Black Hills Regional Eye Institute /ID# 235075
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Vance Thompson Vision /ID# 235072
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Eye Specialty Group /ID# 235721
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 237177
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Advancing Vision Research /ID# 236681
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
ATX Clinical Trials Inc. dba Keystone Research /ID# 235868
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Medical Center Ophthalmology Associates - Keystone Research /ID# 235787
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Southern Utah Medical Research /ID# 235602
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Piedmont Eye Center /ID# 234534
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Consultorio Oftalmologico Dr. Fabian Lerner /ID# 235855
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1122
Country
Argentina
Facility Name
Hospital Universitario Austral /ID# 237727
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
1629
Country
Argentina
Facility Name
Oftalmología Global /ID# 239187
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital Italiano /ID# 235851
City
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Centro Privado de Ojos /ID# 241283
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1033
Country
Argentina
Facility Name
Centro oftalmologico Dr Charles /ID# 235881
City
Ciudad de Buenos Aires
ZIP/Postal Code
1116
Country
Argentina
Facility Name
Oftar Mendoza /ID# 240535
City
Mendoza
ZIP/Postal Code
1019
Country
Argentina
Facility Name
Eye Surgery Associates /ID# 235873
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Multiprofile Hospital for Active Treatment "Lozenetz" /ID# 244053
City
Sofiya
State/Province
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Medical Center Oxycom Burgas /ID# 235580
City
Burgas
ZIP/Postal Code
8008
Country
Bulgaria
Facility Name
UMHAT Sveti Georgi /ID# 237027
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
MHAT Hadzhi Dimitar /ID# 238248
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
MHAT Dr. Bratan Shukerov /ID# 235498
City
Smolyan
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
Medical center for eye healt Focus Ltd /ID# 235575
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Pentagram Eye Hospital /Id# 235813
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment in Ocular Diseases "Zrenie" /ID# 235500
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Diagnostic consultative center Aleksandrovska /ID# 238105
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
St. Sofia Hospital /ID# 235525
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Medical Center -Verea /ID# 235494
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Medical center Orfey /ID# 237344
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
MHAT Trakia /ID# 238137
City
Stara Zagora
ZIP/Postal Code
6004
Country
Bulgaria
Facility Name
Specialized Ophthalmological Hospital for Active Treatment - Varna /ID# 235962
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
Facility Name
Ocni klinika Pardubice /ID# 235944
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady /ID# 234323
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze /ID# 234422
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Rigshospitalet Glostrup /ID# 235743
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Universitatsklinikum Freiburg /ID# 238048
City
Freiburg im Breisgau
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 237069
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum Dresden Friedrichstadt /ID# 235308
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitaetsmedizin Goettingen /ID# 237377
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Asklepios Kinik Nord - Heidberg Augenklinik /ID# 235955
City
Hamburg
ZIP/Postal Code
22417
Country
Germany
Facility Name
St. Franziskus-Hospital /ID# 237714
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Dietrich-Bonhoeffer-Klinikum /ID# 235262
City
Neubrandenburg
ZIP/Postal Code
17036
Country
Germany
Facility Name
Universitaetsmedizin Rostock /ID# 237263
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Augenzentrum Dr Hamacher /ID# 235537
City
Starnberg
ZIP/Postal Code
82319
Country
Germany
Facility Name
Bugat Pal Korhaz /ID# 238144
City
Gyongyos
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz /ID# 237383
City
Szombathely
State/Province
Vas
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Budapest Retina Intezet /ID# 235950
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Jahn Ferenc Del-pesti Korhaz es Rendelointezet /ID# 237111
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Royal Victoria Eye and Ear Hospital /ID# 235546
City
Dublin
ZIP/Postal Code
2
Country
Ireland
Facility Name
Institute of Eye Surgery /ID# 235547
City
Waterford
ZIP/Postal Code
X91 DH9W
Country
Ireland
Facility Name
University of Catanzaro /ID# 238066
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Eye Clinic University of Catania /ID# 235573
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Ospedale Ss. Annunziata /ID# 236587
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Fondazione IRCCS Policlinico /ID# 236909
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
University of Perugia /ID# 235811
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Fondazione Bietti - Ospedale Britannico /ID# 235495
City
Rome
ZIP/Postal Code
00184
Country
Italy
Facility Name
Sapienza University of Rome - Polo Pontino /ID# 237451
City
Terracina
ZIP/Postal Code
04019
Country
Italy
Facility Name
Southern Eye Specialists /ID# 236080
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Capital Eye Specialists /ID# 236112
City
Wellington
ZIP/Postal Code
6011
Country
New Zealand
Facility Name
Wojskowy Instytut Medyczny /ID# 237031
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-349
Country
Poland
Facility Name
Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 237076
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-809
Country
Poland
Facility Name
Gabinet Okulistyczny Edward Wylegala /ID# 235946
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
Medical Center Julianow /ID# 235961
City
Lodz
ZIP/Postal Code
91-485
Country
Poland
Facility Name
Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235928
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
Facility Name
S. Fyodorov Eye Microsurgery Federal State Institution /ID# 235984
City
Novosibirsk
ZIP/Postal Code
630071
Country
Russian Federation
Facility Name
Pretoria Eye Institute - Private Practice /ID# 235658
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Somerset Eye Specialist Medical & Surgical Centre /ID# 235540
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Norrlands University hospital /ID# 237553
City
Umea
State/Province
Vasterbottens Lan
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
The Princess Alexandra NHS Trust /ID# 234433
City
Harlow
State/Province
Essex
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 237282
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust /ID# 238255
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Mid Essex Hospitals NHS Trust /ID# 237776
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
East Suffolk and North Essex NHS Foundation Trust /ID# 234657
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Mid-Cheshire Hospitals NHS Trust /ID# 235418
City
Crewe
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
Liverpool University Hospitals NHS Foundation Trust /ID# 237095
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Liverpool University Hospitals NHS Foundation Trust /ID# 237321
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Central Middlesex Hospital /ID# 236216
City
London
ZIP/Postal Code
NW10 7NS
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 237275
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 237683
City
York
ZIP/Postal Code
YO31 8HE
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/
Learn more about this trial
Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
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