Back to resultsLong-term Safety and Efficacy Extension Trial of Bimatoprost SR
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimatoprost SR
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open-Angle Glaucoma, Ocular Hypertension, Bimatoprost, DURYSTA
Eligibility Criteria
Inclusion Criteria:
- Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
- Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.
Exclusion Criteria:
- Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study.
- Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
- Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
- Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092.
- For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.
Sites / Locations
- Trinity Research Group /ID# 240190
- Arizona Eye Center /ID# 240239
- Arizona Glaucoma Specialists /ID# 240212
- M&M Eye Institute /ID# 240236
- Walman Eye Center /ID# 240255
- Angeles Eye Institute /ID# 250397
- Lakeside Vision Center /ID# 240204
- Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
- The Eye Research Foundation /ID# 240186
- California Eye Specialists Medical Group Inc. /ID# 250979
- North Bay Eye Associates Inc. /ID# 248912
- Martel Eye Medical Group /ID# 240291
- The Clinical Trials Network (CTNx) /ID# 240284
- Sacramento Eye Consultants /ID# 240263
- Pacific Eye Associates /ID# 240234
- Wolstan & Goldberg Eye Associates /ID# 240221
- Colorado Eye Institute /ID# 248910
- Specialty Retina Center /ID# 240254
- Nature Coast Clinical Research - Crystal River /ID# 240334
- Bruce Segal, MD /ID# 240292
- Eye Associates of Fort Meyers /ID# 240218
- Levenson Eye Associates Inc. /ID# 240209
- MedEye Associates /ID# 240333
- Logan Ophthalmic Research Inc. /ID# 240280
- International Research Center /ID# 240346
- University of South Florida /ID# 250980
- Emory University /ID# 240328
- Coastal Research Associates /ID# 240192
- Chicago Eye Specialists /ID# 240270
- University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 250981
- Kovach Eye Institute /ID# 250442
- IN Univ School of Medicine /ID# 240294
- The Eye Care Institute /ID# 240289
- Tulane University /ID# 240327
- Clinical Eye Research of Boston LLC /ID# 240203
- Fraser Eye Center /ID# 240245
- Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402
- Tekwani Vision Center /ID# 240220
- Eye Associates of North Jersey /ID# 250445
- Glaucoma Care Center /ID# 250978
- Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181
- Eye Associates of New Mexico /ID# 240216
- Montefiore Hospital /ID# 240324
- Ophthalmic Consultants Long Island /ID# 240211
- Rochester Ophthalmological Group PC /ID# 240290
- Glaucoma associates/consultants of the capital region /ID# 240195
- Asheville Eye Associates /ID# 240202
- Charlotte Eye,Ear,Nose Throat /ID# 240339
- Albemarle Clinical Trials LLC /ID# 240219
- James D Branch MD /ID# 240188
- Bergstrom Eye Research LLC /ID# 240257
- Oklahoma Eye Surgeons /ID# 250430
- Legacy Devers Eye Institute /ID# 240210
- Scott and Christie and Associates /ID# 240189
- Eye Specialty Group /ID# 240241
- Vanderbilt Eye Institute /ID# 252659
- Advancing Vision Research /ID# 240288
- Keystone Research LTD /ID# 240185
- Houston Eye Associates /ID# 240340
- DCT Shah Eye Research Institut /ID# 240306
- Plano Office /ID# 240243
- San Antonio Eye Center /ID# 240238
- Eye associates /ID# 240265
- Medical Center Ophthalmology Associates /ID# 240208
- Emerson Clinical Research Institute. LLC /ID# 240274
- Piedmont Eye Center /ID# 240187
- Vistar Eye Center /ID# 240198
- Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247
- Clinica Privada de Ojos /ID# 240272
- Hospital Universitario Austral /ID# 240331
- Oftalmología Global /ID# 240244
- Oftar Mendoza /ID# 240308
- Universitair Ziekenhuis Leuven /ID# 240312
- Hospital das Clinicas da Universidade Federal de Goiás /ID# 240344
- Clinica De Oftalmologia Nova Campinas /ID# 240271
- Hospital Oftalmologico Medicina dos Olhos /ID# 240277
- Hospital de Olhos de Mato Grosso Do Sul /ID# 240276
- Hospital Sao Paulo /ID# 240278
- Dalhousie University /ID# 240336
- Ophthalmic Consultant Centres /ID# 240205
- Clinica de Oftalmologia Sandiego /ID# 240233
- Fundacion Oftalmologica Nacional /ID# 240226
- Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634
- Ocni klinika Pardubice /ID# 240347
- Rigshospitalet Glostrup /ID# 240330
- Ain Shams University Hospital /ID# 240338
- Bostan Diagnostic Eye Center /ID# 240268
- CHU Bordeaux - Hopital Pellegrin /ID# 240316
- Centre Ophtalmologique Pôle Vision /ID# 240256
- Internationale Innovative Ophthalmochirurgie /ID# 240232
- Universitaetsklinikum Magdeburg /ID# 240314
- The Chinese University of Hong Kong /ID# 240283
- Tel Aviv Sourasky Medical Center /ID# 240311
- Rambam Health Care Campus /ID# 240332
- Bnai Zion Medical Center /ID# 240297
- The Lady Davis Carmel Medical Center /ID# 240293
- Azienda Ospedaliera di Perugia /ID# 240310
- A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305
- Azienda Sanitaria Locale (ASL) Chieti /ID# 240217
- Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 240301
- Seoul National University Hospital /ID# 240262
- Asan Medical Center /ID# 240286
- Samsung Medical Center /ID# 240335
- Capital Eye Specialists /ID# 240259
- Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269
- Asian Eye Institute /ID# 240213
- Asian Eye Institute /ID# 240214
- Peregrine Eye and Laser Institute /ID# 240260
- Optinum Profesorskie Centrum Okulistyki /ID# 240307
- OFTALMIKA Sp. z o.o. /ID# 240201
- Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258
- Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 240248
- S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251
- Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253
- Singapore National Eye Centre /ID# 240224
- Pretoria Eye Institute - Private Practice /ID# 240223
- Hospital Universitario Reina Sofia /ID# 240322
- Hospital Clinico Universitario San Carlos /ID# 240303
- Hospital Universitario Virgen Macarena /ID# 240325
- Maharaj Nakorn Chiang Mai Hospital /ID# 240194
- Thammasat University Hospital /ID# 240231
- Eskisehir Osmangazi University Medical School /ID# 240225
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240287
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296
- Cambridge University Hospitals NHS Foundation Trust /ID# 240351
- Duplicate_NHS Lothian /ID# 240318
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Lead-in study 192024-091 or -092 or -095
Lead-in study 192024-093 Stage 1
Lead-in study 192024-093 Stage 2
Lead-in study ARGOS
Arm Description
Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Participants in Lead-in Study 192024-093 Stage 1 and participants in Stage 2 who received only 1 Bimatoprost administration due to safety concerns: Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Participants in Lead-in Study 192024-093 Stage 2 who received only 2 Bimatoprost administrations or 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Study eye (Eye that received Bimatoprost SR first in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment.
Outcomes
Primary Outcome Measures
Duration of effect of Bimatoprost SR
Retreatment or rescue administered for IOP lowering, determined by the investigator.
Number of patients experiencing a treatment emergent adverse event
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03891446
Brief Title
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Official Title
An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
June 13, 2025 (Anticipated)
Study Completion Date
June 13, 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 will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.
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, Ocular Hypertension, Bimatoprost, DURYSTA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lead-in study 192024-091 or -092 or -095
Arm Type
Experimental
Arm Description
Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered.
Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Arm Title
Lead-in study 192024-093 Stage 1
Arm Type
Experimental
Arm Description
Participants in Lead-in Study 192024-093 Stage 1 and participants in Stage 2 who received only 1 Bimatoprost administration due to safety concerns:
Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered.
Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Arm Title
Lead-in study 192024-093 Stage 2
Arm Type
Experimental
Arm Description
Participants in Lead-in Study 192024-093 Stage 2 who received only 2 Bimatoprost administrations or 1 Bimatoprost administration due to sustained efficacy:
Study eye (Eye that received Bimatoprost SR in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Arm Title
Lead-in study ARGOS
Arm Type
Experimental
Arm Description
Study eye (Eye that received Bimatoprost SR first in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost SR
Other Intervention Name(s)
DURYSTA
Intervention Description
Intraocular implant
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care treatment based on investigator's judgement.
Primary Outcome Measure Information:
Title
Duration of effect of Bimatoprost SR
Description
Retreatment or rescue administered for IOP lowering, determined by the investigator.
Time Frame
Approximately 24 months
Title
Number of patients experiencing a treatment emergent adverse event
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Time Frame
Approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.
Exclusion Criteria:
Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study.
Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092.
For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow 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
Trinity Research Group /ID# 240190
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Arizona Eye Center /ID# 240239
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Glaucoma Specialists /ID# 240212
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050-4265
Country
United States
Facility Name
M&M Eye Institute /ID# 240236
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
Walman Eye Center /ID# 240255
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Angeles Eye Institute /ID# 250397
City
Culver City
State/Province
California
ZIP/Postal Code
90232
Country
United States
Facility Name
Lakeside Vision Center /ID# 240204
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Facility Name
Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
The Eye Research Foundation /ID# 240186
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3637
Country
United States
Facility Name
California Eye Specialists Medical Group Inc. /ID# 250979
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
North Bay Eye Associates Inc. /ID# 248912
City
Petaluma
State/Province
California
ZIP/Postal Code
94954-2387
Country
United States
Facility Name
Martel Eye Medical Group /ID# 240291
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670-2968
Country
United States
Facility Name
The Clinical Trials Network (CTNx) /ID# 240284
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Sacramento Eye Consultants /ID# 240263
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Pacific Eye Associates /ID# 240234
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates /ID# 240221
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Colorado Eye Institute /ID# 248910
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80924-7003
Country
United States
Facility Name
Specialty Retina Center /ID# 240254
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Nature Coast Clinical Research - Crystal River /ID# 240334
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Bruce Segal, MD /ID# 240292
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484-6540
Country
United States
Facility Name
Eye Associates of Fort Meyers /ID# 240218
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Levenson Eye Associates Inc. /ID# 240209
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
MedEye Associates /ID# 240333
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Logan Ophthalmic Research Inc. /ID# 240280
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
International Research Center /ID# 240346
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
University of South Florida /ID# 250980
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University /ID# 240328
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Coastal Research Associates /ID# 240192
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Chicago Eye Specialists /ID# 240270
City
Bedford Park
State/Province
Illinois
ZIP/Postal Code
60638
Country
United States
Facility Name
University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 250981
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Kovach Eye Institute /ID# 250442
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126-2821
Country
United States
Facility Name
IN Univ School of Medicine /ID# 240294
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
Facility Name
The Eye Care Institute /ID# 240289
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206-1738
Country
United States
Facility Name
Tulane University /ID# 240327
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2699
Country
United States
Facility Name
Clinical Eye Research of Boston LLC /ID# 240203
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Fraser Eye Center /ID# 240245
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Facility Name
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Tekwani Vision Center /ID# 240220
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Eye Associates of North Jersey /ID# 250445
City
Dover
State/Province
New Jersey
ZIP/Postal Code
07801-1629
Country
United States
Facility Name
Glaucoma Care Center /ID# 250978
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103-2425
Country
United States
Facility Name
Eye Associates of New Mexico /ID# 240216
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Montefiore Hospital /ID# 240324
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2404
Country
United States
Facility Name
Ophthalmic Consultants Long Island /ID# 240211
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Rochester Ophthalmological Group PC /ID# 240290
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-2616
Country
United States
Facility Name
Glaucoma associates/consultants of the capital region /ID# 240195
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
Asheville Eye Associates /ID# 240202
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Charlotte Eye,Ear,Nose Throat /ID# 240339
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
Facility Name
Albemarle Clinical Trials LLC /ID# 240219
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
Facility Name
James D Branch MD /ID# 240188
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Bergstrom Eye Research LLC /ID# 240257
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Oklahoma Eye Surgeons /ID# 250430
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Legacy Devers Eye Institute /ID# 240210
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Scott and Christie and Associates /ID# 240189
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Eye Specialty Group /ID# 240241
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt Eye Institute /ID# 252659
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Advancing Vision Research /ID# 240288
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Keystone Research LTD /ID# 240185
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-4203
Country
United States
Facility Name
Houston Eye Associates /ID# 240340
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
DCT Shah Eye Research Institut /ID# 240306
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States
Facility Name
Plano Office /ID# 240243
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
San Antonio Eye Center /ID# 240238
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Eye associates /ID# 240265
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical Center Ophthalmology Associates /ID# 240208
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1502
Country
United States
Facility Name
Emerson Clinical Research Institute. LLC /ID# 240274
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
Piedmont Eye Center /ID# 240187
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Vistar Eye Center /ID# 240198
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24011
Country
United States
Facility Name
Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1122
Country
Argentina
Facility Name
Clinica Privada de Ojos /ID# 240272
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Hospital Universitario Austral /ID# 240331
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
1629
Country
Argentina
Facility Name
Oftalmología Global /ID# 240244
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Oftar Mendoza /ID# 240308
City
Mendoza
ZIP/Postal Code
1019
Country
Argentina
Facility Name
Universitair Ziekenhuis Leuven /ID# 240312
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital das Clinicas da Universidade Federal de Goiás /ID# 240344
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605-020
Country
Brazil
Facility Name
Clinica De Oftalmologia Nova Campinas /ID# 240271
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13092-108
Country
Brazil
Facility Name
Hospital Oftalmologico Medicina dos Olhos /ID# 240277
City
Osasco
State/Province
Sao Paulo
ZIP/Postal Code
0601-8180
Country
Brazil
Facility Name
Hospital de Olhos de Mato Grosso Do Sul /ID# 240276
City
Campo Grande
ZIP/Postal Code
79002-075
Country
Brazil
Facility Name
Hospital Sao Paulo /ID# 240278
City
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Dalhousie University /ID# 240336
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Ophthalmic Consultant Centres /ID# 240205
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1W9
Country
Canada
Facility Name
Clinica de Oftalmologia Sandiego /ID# 240233
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050016
Country
Colombia
Facility Name
Fundacion Oftalmologica Nacional /ID# 240226
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110231
Country
Colombia
Facility Name
Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634
City
Floridablanca
State/Province
Santander
ZIP/Postal Code
681004
Country
Colombia
Facility Name
Ocni klinika Pardubice /ID# 240347
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Rigshospitalet Glostrup /ID# 240330
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Ain Shams University Hospital /ID# 240338
City
Cairo
Country
Egypt
Facility Name
Bostan Diagnostic Eye Center /ID# 240268
City
Cairo
Country
Egypt
Facility Name
CHU Bordeaux - Hopital Pellegrin /ID# 240316
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Ophtalmologique Pôle Vision /ID# 240256
City
Ecully
ZIP/Postal Code
69130
Country
France
Facility Name
Internationale Innovative Ophthalmochirurgie /ID# 240232
City
Dusseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40212
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg /ID# 240314
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
The Chinese University of Hong Kong /ID# 240283
City
Hong Kong
Country
Hong Kong
Facility Name
Tel Aviv Sourasky Medical Center /ID# 240311
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 240332
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Bnai Zion Medical Center /ID# 240297
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
The Lady Davis Carmel Medical Center /ID# 240293
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Azienda Ospedaliera di Perugia /ID# 240310
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Facility Name
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Sanitaria Locale (ASL) Chieti /ID# 240217
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 240301
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Seoul National University Hospital /ID# 240262
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 240286
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 240335
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Capital Eye Specialists /ID# 240259
City
Wellington
ZIP/Postal Code
6011
Country
New Zealand
Facility Name
Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Asian Eye Institute /ID# 240213
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Asian Eye Institute /ID# 240214
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Peregrine Eye and Laser Institute /ID# 240260
City
Makati City
ZIP/Postal Code
1209
Country
Philippines
Facility Name
Optinum Profesorskie Centrum Okulistyki /ID# 240307
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-809
Country
Poland
Facility Name
OFTALMIKA Sp. z o.o. /ID# 240201
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Facility Name
Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 240248
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
Facility Name
S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251
City
Novosibirsk
ZIP/Postal Code
630071
Country
Russian Federation
Facility Name
Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
Singapore National Eye Centre /ID# 240224
City
Singapore
ZIP/Postal Code
168251
Country
Singapore
Facility Name
Pretoria Eye Institute - Private Practice /ID# 240223
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Hospital Universitario Reina Sofia /ID# 240322
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 240303
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 240325
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Maharaj Nakorn Chiang Mai Hospital /ID# 240194
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Thammasat University Hospital /ID# 240231
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Eskisehir Osmangazi University Medical School /ID# 240225
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240287
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Cambridge University Hospitals NHS Foundation Trust /ID# 240351
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Duplicate_NHS Lothian /ID# 240318
City
Edinburgh
ZIP/Postal Code
EH3 9HE
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/
Links:
URL
https://www.rxabbvie.com/
Description
Related Info
Learn more about this trial
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
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