Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
- Conditions
- Ocular HypertensionOpen-Angle Glaucoma
- Interventions
- Drug: Bimatoprost SROther: Standard of Care
- Registration Number
- NCT03891446
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lead-in study 192024-093 Stage 2 Bimatoprost SR Participants who received 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. 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. Lead-in study ARGOS Bimatoprost SR Study eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. 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. Lead-in study 192024-091 or -092 or -095 Standard of Care 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. Lead-in study 192024-093 Stage 1 Standard of Care Participants who received 1, 2 or 3 administrations and participants in Stage 2 who received 1 Bimatoprost SR administration due to safety concern or received 2 administrations. 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. Lead-in study 192024-093 Stage 2 Standard of Care Participants who received 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. 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. Lead-in study ARGOS Standard of Care Study eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. 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.
- Primary Outcome Measures
Name Time Method Duration of effect of Bimatoprost SR Approximately 24 months Retreatment or rescue administered for IOP lowering, determined by the investigator.
Number of patients experiencing a treatment emergent adverse event Approximately 24 months 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
Name Time Method
Trial Locations
- Locations (124)
Lakeside Vision Center /ID# 240204
🇺🇸Irvine, California, United States
The Eye Research Foundation /ID# 240186
🇺🇸Newport Beach, California, United States
Wolstan & Goldberg Eye Associates /ID# 240221
🇺🇸Torrance, California, United States
Bruce Segal, MD /ID# 240292
🇺🇸Delray Beach, Florida, United States
Eye Associates of Fort Meyers /ID# 240218
🇺🇸Fort Myers, Florida, United States
University of Illinois at Chicago /ID# 250981
🇺🇸Chicago, Illinois, United States
Glaucoma Care Center /ID# 250978
🇺🇸Livingston, New Jersey, United States
Thammasat University Hospital /ID# 240231
🇹🇭Pathumthani, Thailand
IN Univ School of Medicine /ID# 240294
🇺🇸Indianapolis, Indiana, United States
Houston Eye Associates /ID# 240340
🇺🇸Houston, Texas, United States
MedEye Associates /ID# 240333
🇺🇸Miami, Florida, United States
Dalhousie University /ID# 240336
🇨🇦Halifax, Nova Scotia, Canada
Trinity Research Group /ID# 240190
🇺🇸Dothan, Alabama, United States
Arizona Eye Center /ID# 240239
🇺🇸Chandler, Arizona, United States
Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258
🇵🇱Lublin, Poland
Singapore National Eye Centre /ID# 240224
🇸🇬Singapore, Singapore
Pacific Eye Associates /ID# 240234
🇺🇸San Francisco, California, United States
Vanderbilt Eye Institute /ID# 252659
🇺🇸Nashville, Tennessee, United States
Eye associates /ID# 240265
🇺🇸San Antonio, Texas, United States
Medical Center Ophthalmology Associates /ID# 240208
🇺🇸San Antonio, Texas, United States
Azienda Ospedaliera di Perugia /ID# 240310
🇮🇹Perugia, Umbria, Italy
Hospital Sao Paulo /ID# 240278
🇧🇷Sao Paulo, Brazil
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402
🇺🇸Chesterfield, Missouri, United States
M&M Eye Institute /ID# 240236
🇺🇸Prescott, Arizona, United States
Angeles Eye Institute /ID# 250397
🇺🇸Culver City, California, United States
Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
🇺🇸La Jolla, California, United States
North Bay Eye Associates Inc. /ID# 248912
🇺🇸Petaluma, California, United States
The Clinical Trials Network (CTNx) /ID# 240284
🇺🇸Redding, California, United States
Specialty Retina Center /ID# 240254
🇺🇸Coral Springs, Florida, United States
Nature Coast Clinical Research - Crystal River /ID# 240334
🇺🇸Crystal River, Florida, United States
Logan Ophthalmic Research Inc. /ID# 240280
🇺🇸Tamarac, Florida, United States
Coastal Research Associates /ID# 240192
🇺🇸Roswell, Georgia, United States
Chicago Eye Specialists /ID# 240270
🇺🇸Bedford Park, Illinois, United States
Kovach Eye Institute /ID# 250442
🇺🇸Elmhurst, Illinois, United States
Clinical Eye Research of Boston LLC /ID# 240203
🇺🇸Winchester, Massachusetts, United States
Fraser Eye Center /ID# 240245
🇺🇸Fraser, Michigan, United States
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181
🇺🇸Newark, New Jersey, United States
Ophthalmic Consultants Long Island /ID# 240211
🇺🇸Oceanside, New York, United States
Eye Associates of North Jersey /ID# 250445
🇺🇸Dover, New Jersey, United States
Eye Associates of New Mexico /ID# 240216
🇺🇸Albuquerque, New Mexico, United States
Rochester Ophthalmological Group PC /ID# 240290
🇺🇸Rochester, New York, United States
Glaucoma associates/consultants of the capital region /ID# 240195
🇺🇸Slingerlands, New York, United States
Asheville Eye Associates /ID# 240202
🇺🇸Asheville, North Carolina, United States
Charlotte Eye,Ear,Nose Throat /ID# 240339
🇺🇸Belmont, North Carolina, United States
Albemarle Clinical Trials LLC /ID# 240219
🇺🇸Elizabeth City, North Carolina, United States
Bergstrom Eye Research LLC /ID# 240257
🇺🇸Fargo, North Dakota, United States
Scott and Christie and Associates /ID# 240189
🇺🇸Cranberry Township, Pennsylvania, United States
Advancing Vision Research /ID# 240288
🇺🇸Smyrna, Tennessee, United States
Plano Office /ID# 240243
🇺🇸Plano, Texas, United States
Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247
🇦🇷Caba, Buenos Aires, Argentina
DCT Shah Eye Research Institut /ID# 240306
🇺🇸Mission, Texas, United States
Piedmont Eye Center /ID# 240187
🇺🇸Lynchburg, Virginia, United States
San Antonio Eye Center /ID# 240238
🇺🇸San Antonio, Texas, United States
Emerson Clinical Research Institute. LLC /ID# 240274
🇺🇸Falls Church, Virginia, United States
Clinica Privada de Ojos /ID# 240272
🇦🇷Mar del Plata, Buenos Aires, Argentina
Oftar Mendoza /ID# 240308
🇦🇷Mendoza, Argentina
Clinica De Oftalmologia Nova Campinas /ID# 240271
🇧🇷Campinas, Sao Paulo, Brazil
Hospital Oftalmologico Medicina dos Olhos /ID# 240277
🇧🇷Osasco, Sao Paulo, Brazil
Hospital de Olhos de Mato Grosso Do Sul /ID# 240276
🇧🇷Campo Grande, Brazil
Fundacion Oftalmologica Nacional /ID# 240226
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Ocni klinika Pardubice /ID# 240347
🇨🇿Pardubice, Czechia
Ain Shams University Hospital /ID# 240338
🇪🇬Cairo, Egypt
Bostan Diagnostic Eye Center /ID# 240268
🇪🇬Cairo, Egypt
CHU Bordeaux - Hopital Pellegrin /ID# 240316
🇫🇷Bordeaux CEDEX, Gironde, France
Rigshospitalet Glostrup /ID# 240330
🇩🇰Glostrup, Hovedstaden, Denmark
Internationale Innovative Ophthalmochirurgie /ID# 240232
🇩🇪Dusseldorf, Nordrhein-Westfalen, Germany
Centre Ophtalmologique Pôle Vision /ID# 240256
🇫🇷Ecully, France
Galilee Medical Center /ID# 251967
🇮🇱Naharia, HaTsafon, Israel
The Chinese University of Hong Kong /ID# 240283
🇭🇰Hong Kong, Hong Kong
Universitaetsklinikum Magdeburg /ID# 240314
🇩🇪Magdeburg, Germany
The Lady Davis Carmel Medical Center /ID# 240293
🇮🇱Haifa, H_efa, Israel
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305
🇮🇹Catania, Italy
Azienda Sanitaria Locale (ASL) Chieti /ID# 240217
🇮🇹Chieti, Italy
Seoul National University Hospital /ID# 240262
🇰🇷Seoul, Korea, Republic of
Azienda Ospedaliero Universitaria Pisana /ID# 240301
🇮🇹Pisa, Italy
Asan Medical Center /ID# 240286
🇰🇷Seoul, Korea, Republic of
Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269
🇵🇪Lima, Peru
Capital Eye Specialists /ID# 240259
🇳🇿Wellington, New Zealand
Samsung Medical Center /ID# 240335
🇰🇷Seoul, Korea, Republic of
Asian Eye Institute /ID# 240214
🇵🇭Makati City, Philippines
Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307
🇵🇱Gdansk, Pomorskie, Poland
Peregrine Eye and Laser Institute /ID# 240260
🇵🇭Makati City, Philippines
OFTALMIKA Sp. z o.o. /ID# 240201
🇵🇱Bydgoszcz, Poland
Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248
🇵🇱Olsztyn, Poland
Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253
🇷🇺Omsk, Russian Federation
Hospital Universitario Virgen Macarena /ID# 240325
🇪🇸Sevilla, Spain
S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251
🇷🇺Novosibirsk, Russian Federation
Pretoria Eye Institute - Private Practice /ID# 240223
🇿🇦Pretoria, Gauteng, South Africa
Hospital Universitario Reina Sofia /ID# 240322
🇪🇸Cordoba, Spain
Maharaj Nakorn Chiang Mai Hospital /ID# 240194
🇹🇭Chiang Mai, Thailand
Eskisehir Osmangazi University Medical School /ID# 240225
🇹🇷Eskisehir, Turkey
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296
🇹🇷Istanbul, Turkey
Duplicate_NHS Lothian /ID# 240318
🇬🇧Edinburgh, United Kingdom
Colorado Eye Institute /ID# 248910
🇺🇸Colorado Springs, Colorado, United States
Martel Eye Medical Group /ID# 240291
🇺🇸Rancho Cordova, California, United States
Levenson Eye Associates Inc. /ID# 240209
🇺🇸Jacksonville, Florida, United States
Tel Aviv Sourasky Medical Center /ID# 240311
🇮🇱Tel Aviv, Tel-Aviv, Israel
Emory University /ID# 240328
🇺🇸Atlanta, Georgia, United States
Tekwani Vision Center /ID# 240220
🇺🇸Saint Louis, Missouri, United States
Vistar Eye Center /ID# 240198
🇺🇸Roanoke, Virginia, United States
Eye Specialty Group /ID# 240241
🇺🇸Memphis, Tennessee, United States
Hospital Universitario Austral /ID# 240331
🇦🇷Pilar, Buenos Aires, Argentina
Ophthalmic Consultant Centres /ID# 240205
🇨🇦Mississauga, Ontario, Canada
Rambam Health Care Campus /ID# 240332
🇮🇱Haifa, H_efa, Israel
Cambridge University Hospitals NHS Foundation Trust /ID# 240351
🇬🇧Cambridge, United Kingdom
Bnai Zion Medical Center /ID# 240297
🇮🇱Haifa, H_efa, Israel
Hospital Clinico Universitario San Carlos /ID# 240303
🇪🇸Madrid, Spain
Keystone Research LTD /ID# 240185
🇺🇸Austin, Texas, United States
Oftalmología Global /ID# 240244
🇦🇷Rosario, Santa Fe, Argentina
Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634
🇨🇴Bucaramanga, Santander, Colombia
Clinica de Oftalmologia Sandiego /ID# 240233
🇨🇴Medellin, Antioquia, Colombia
Asian Eye Institute /ID# 240213
🇵🇭Makati City, Philippines
Universitair Ziekenhuis Leuven /ID# 240312
🇧🇪Leuven, Vlaams-Brabant, Belgium
Arizona Glaucoma Specialists /ID# 240212
🇺🇸Phoenix, Arizona, United States
International Research Center /ID# 240346
🇺🇸Tampa, Florida, United States
James D Branch MD /ID# 240188
🇺🇸Winston-Salem, North Carolina, United States
Oklahoma Eye Surgeons /ID# 250430
🇺🇸Oklahoma City, Oklahoma, United States
Sacramento Eye Consultants /ID# 240263
🇺🇸Sacramento, California, United States
University of South Florida /ID# 250980
🇺🇸Tampa, Florida, United States
The Eye Care Institute /ID# 240289
🇺🇸Louisville, Kentucky, United States
Legacy Devers Eye Institute /ID# 240210
🇺🇸Portland, Oregon, United States
Tulane University /ID# 240327
🇺🇸New Orleans, Louisiana, United States
Montefiore Hospital /ID# 240324
🇺🇸Bronx, New York, United States
Walman Eye Center /ID# 240255
🇺🇸Sun City, Arizona, United States