MedPath

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Phase 3
Conditions
Ocular Hypertension
Open-Angle Glaucoma
Interventions
Drug: Bimatoprost SR
Other: 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
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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lead-in study 192024-093 Stage 2Bimatoprost SRParticipants 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 ARGOSBimatoprost SRStudy 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 -095Standard of CareStudy 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 1Standard of CareParticipants 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 2Standard of CareParticipants 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 ARGOSStandard of CareStudy 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
NameTimeMethod
Duration of effect of Bimatoprost SRApproximately 24 months

Retreatment or rescue administered for IOP lowering, determined by the investigator.

Number of patients experiencing a treatment emergent adverse eventApproximately 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
NameTimeMethod

Trial Locations

Locations (124)

Lakeside Vision Center /ID# 240204

๐Ÿ‡บ๐Ÿ‡ธ

Irvine, California, United States

The Eye Research Foundation /ID# 240186

๐Ÿ‡บ๐Ÿ‡ธ

Newport Beach, California, United States

Wolstan & Goldberg Eye Associates /ID# 240221

๐Ÿ‡บ๐Ÿ‡ธ

Torrance, California, United States

Bruce Segal, MD /ID# 240292

๐Ÿ‡บ๐Ÿ‡ธ

Delray Beach, Florida, United States

Eye Associates of Fort Meyers /ID# 240218

๐Ÿ‡บ๐Ÿ‡ธ

Fort Myers, Florida, United States

University of Illinois at Chicago /ID# 250981

๐Ÿ‡บ๐Ÿ‡ธ

Chicago, Illinois, United States

Glaucoma Care Center /ID# 250978

๐Ÿ‡บ๐Ÿ‡ธ

Livingston, New Jersey, United States

Thammasat University Hospital /ID# 240231

๐Ÿ‡น๐Ÿ‡ญ

Pathumthani, Thailand

IN Univ School of Medicine /ID# 240294

๐Ÿ‡บ๐Ÿ‡ธ

Indianapolis, Indiana, United States

Houston Eye Associates /ID# 240340

๐Ÿ‡บ๐Ÿ‡ธ

Houston, Texas, United States

MedEye Associates /ID# 240333

๐Ÿ‡บ๐Ÿ‡ธ

Miami, Florida, United States

Dalhousie University /ID# 240336

๐Ÿ‡จ๐Ÿ‡ฆ

Halifax, Nova Scotia, Canada

Trinity Research Group /ID# 240190

๐Ÿ‡บ๐Ÿ‡ธ

Dothan, Alabama, United States

Arizona Eye Center /ID# 240239

๐Ÿ‡บ๐Ÿ‡ธ

Chandler, Arizona, United States

Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258

๐Ÿ‡ต๐Ÿ‡ฑ

Lublin, Poland

Singapore National Eye Centre /ID# 240224

๐Ÿ‡ธ๐Ÿ‡ฌ

Singapore, Singapore

Pacific Eye Associates /ID# 240234

๐Ÿ‡บ๐Ÿ‡ธ

San Francisco, California, United States

Vanderbilt Eye Institute /ID# 252659

๐Ÿ‡บ๐Ÿ‡ธ

Nashville, Tennessee, United States

Eye associates /ID# 240265

๐Ÿ‡บ๐Ÿ‡ธ

San Antonio, Texas, United States

Medical Center Ophthalmology Associates /ID# 240208

๐Ÿ‡บ๐Ÿ‡ธ

San Antonio, Texas, United States

Azienda Ospedaliera di Perugia /ID# 240310

๐Ÿ‡ฎ๐Ÿ‡น

Perugia, Umbria, Italy

Hospital Sao Paulo /ID# 240278

๐Ÿ‡ง๐Ÿ‡ท

Sao Paulo, Brazil

Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402

๐Ÿ‡บ๐Ÿ‡ธ

Chesterfield, Missouri, United States

M&M Eye Institute /ID# 240236

๐Ÿ‡บ๐Ÿ‡ธ

Prescott, Arizona, United States

Angeles Eye Institute /ID# 250397

๐Ÿ‡บ๐Ÿ‡ธ

Culver City, California, United States

Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196

๐Ÿ‡บ๐Ÿ‡ธ

La Jolla, California, United States

North Bay Eye Associates Inc. /ID# 248912

๐Ÿ‡บ๐Ÿ‡ธ

Petaluma, California, United States

The Clinical Trials Network (CTNx) /ID# 240284

๐Ÿ‡บ๐Ÿ‡ธ

Redding, California, United States

Specialty Retina Center /ID# 240254

๐Ÿ‡บ๐Ÿ‡ธ

Coral Springs, Florida, United States

Nature Coast Clinical Research - Crystal River /ID# 240334

๐Ÿ‡บ๐Ÿ‡ธ

Crystal River, Florida, United States

Logan Ophthalmic Research Inc. /ID# 240280

๐Ÿ‡บ๐Ÿ‡ธ

Tamarac, Florida, United States

Coastal Research Associates /ID# 240192

๐Ÿ‡บ๐Ÿ‡ธ

Roswell, Georgia, United States

Chicago Eye Specialists /ID# 240270

๐Ÿ‡บ๐Ÿ‡ธ

Bedford Park, Illinois, United States

Kovach Eye Institute /ID# 250442

๐Ÿ‡บ๐Ÿ‡ธ

Elmhurst, Illinois, United States

Clinical Eye Research of Boston LLC /ID# 240203

๐Ÿ‡บ๐Ÿ‡ธ

Winchester, Massachusetts, United States

Fraser Eye Center /ID# 240245

๐Ÿ‡บ๐Ÿ‡ธ

Fraser, Michigan, United States

Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181

๐Ÿ‡บ๐Ÿ‡ธ

Newark, New Jersey, United States

Ophthalmic Consultants Long Island /ID# 240211

๐Ÿ‡บ๐Ÿ‡ธ

Oceanside, New York, United States

Eye Associates of North Jersey /ID# 250445

๐Ÿ‡บ๐Ÿ‡ธ

Dover, New Jersey, United States

Eye Associates of New Mexico /ID# 240216

๐Ÿ‡บ๐Ÿ‡ธ

Albuquerque, New Mexico, United States

Rochester Ophthalmological Group PC /ID# 240290

๐Ÿ‡บ๐Ÿ‡ธ

Rochester, New York, United States

Glaucoma associates/consultants of the capital region /ID# 240195

๐Ÿ‡บ๐Ÿ‡ธ

Slingerlands, New York, United States

Asheville Eye Associates /ID# 240202

๐Ÿ‡บ๐Ÿ‡ธ

Asheville, North Carolina, United States

Charlotte Eye,Ear,Nose Throat /ID# 240339

๐Ÿ‡บ๐Ÿ‡ธ

Belmont, North Carolina, United States

Albemarle Clinical Trials LLC /ID# 240219

๐Ÿ‡บ๐Ÿ‡ธ

Elizabeth City, North Carolina, United States

Bergstrom Eye Research LLC /ID# 240257

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Fargo, North Dakota, United States

Scott and Christie and Associates /ID# 240189

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Cranberry Township, Pennsylvania, United States

Advancing Vision Research /ID# 240288

๐Ÿ‡บ๐Ÿ‡ธ

Smyrna, Tennessee, United States

Plano Office /ID# 240243

๐Ÿ‡บ๐Ÿ‡ธ

Plano, Texas, United States

Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247

๐Ÿ‡ฆ๐Ÿ‡ท

Caba, Buenos Aires, Argentina

DCT Shah Eye Research Institut /ID# 240306

๐Ÿ‡บ๐Ÿ‡ธ

Mission, Texas, United States

Piedmont Eye Center /ID# 240187

๐Ÿ‡บ๐Ÿ‡ธ

Lynchburg, Virginia, United States

San Antonio Eye Center /ID# 240238

๐Ÿ‡บ๐Ÿ‡ธ

San Antonio, Texas, United States

Emerson Clinical Research Institute. LLC /ID# 240274

๐Ÿ‡บ๐Ÿ‡ธ

Falls Church, Virginia, United States

Clinica Privada de Ojos /ID# 240272

๐Ÿ‡ฆ๐Ÿ‡ท

Mar del Plata, Buenos Aires, Argentina

Oftar Mendoza /ID# 240308

๐Ÿ‡ฆ๐Ÿ‡ท

Mendoza, Argentina

Clinica De Oftalmologia Nova Campinas /ID# 240271

๐Ÿ‡ง๐Ÿ‡ท

Campinas, Sao Paulo, Brazil

Hospital Oftalmologico Medicina dos Olhos /ID# 240277

๐Ÿ‡ง๐Ÿ‡ท

Osasco, Sao Paulo, Brazil

Hospital de Olhos de Mato Grosso Do Sul /ID# 240276

๐Ÿ‡ง๐Ÿ‡ท

Campo Grande, Brazil

Fundacion Oftalmologica Nacional /ID# 240226

๐Ÿ‡จ๐Ÿ‡ด

Bogota, Distrito Capital De Bogota, Colombia

Ocni klinika Pardubice /ID# 240347

๐Ÿ‡จ๐Ÿ‡ฟ

Pardubice, Czechia

Ain Shams University Hospital /ID# 240338

๐Ÿ‡ช๐Ÿ‡ฌ

Cairo, Egypt

Bostan Diagnostic Eye Center /ID# 240268

๐Ÿ‡ช๐Ÿ‡ฌ

Cairo, Egypt

CHU Bordeaux - Hopital Pellegrin /ID# 240316

๐Ÿ‡ซ๐Ÿ‡ท

Bordeaux CEDEX, Gironde, France

Rigshospitalet Glostrup /ID# 240330

๐Ÿ‡ฉ๐Ÿ‡ฐ

Glostrup, Hovedstaden, Denmark

Internationale Innovative Ophthalmochirurgie /ID# 240232

๐Ÿ‡ฉ๐Ÿ‡ช

Dusseldorf, Nordrhein-Westfalen, Germany

Centre Ophtalmologique Pรดle Vision /ID# 240256

๐Ÿ‡ซ๐Ÿ‡ท

Ecully, France

Galilee Medical Center /ID# 251967

๐Ÿ‡ฎ๐Ÿ‡ฑ

Naharia, HaTsafon, Israel

The Chinese University of Hong Kong /ID# 240283

๐Ÿ‡ญ๐Ÿ‡ฐ

Hong Kong, Hong Kong

Universitaetsklinikum Magdeburg /ID# 240314

๐Ÿ‡ฉ๐Ÿ‡ช

Magdeburg, Germany

The Lady Davis Carmel Medical Center /ID# 240293

๐Ÿ‡ฎ๐Ÿ‡ฑ

Haifa, H_efa, Israel

A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305

๐Ÿ‡ฎ๐Ÿ‡น

Catania, Italy

Azienda Sanitaria Locale (ASL) Chieti /ID# 240217

๐Ÿ‡ฎ๐Ÿ‡น

Chieti, Italy

Seoul National University Hospital /ID# 240262

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Azienda Ospedaliero Universitaria Pisana /ID# 240301

๐Ÿ‡ฎ๐Ÿ‡น

Pisa, Italy

Asan Medical Center /ID# 240286

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269

๐Ÿ‡ต๐Ÿ‡ช

Lima, Peru

Capital Eye Specialists /ID# 240259

๐Ÿ‡ณ๐Ÿ‡ฟ

Wellington, New Zealand

Samsung Medical Center /ID# 240335

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Asian Eye Institute /ID# 240214

๐Ÿ‡ต๐Ÿ‡ญ

Makati City, Philippines

Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307

๐Ÿ‡ต๐Ÿ‡ฑ

Gdansk, Pomorskie, Poland

Peregrine Eye and Laser Institute /ID# 240260

๐Ÿ‡ต๐Ÿ‡ญ

Makati City, Philippines

OFTALMIKA Sp. z o.o. /ID# 240201

๐Ÿ‡ต๐Ÿ‡ฑ

Bydgoszcz, Poland

Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248

๐Ÿ‡ต๐Ÿ‡ฑ

Olsztyn, Poland

Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253

๐Ÿ‡ท๐Ÿ‡บ

Omsk, Russian Federation

Hospital Universitario Virgen Macarena /ID# 240325

๐Ÿ‡ช๐Ÿ‡ธ

Sevilla, Spain

S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251

๐Ÿ‡ท๐Ÿ‡บ

Novosibirsk, Russian Federation

Pretoria Eye Institute - Private Practice /ID# 240223

๐Ÿ‡ฟ๐Ÿ‡ฆ

Pretoria, Gauteng, South Africa

Hospital Universitario Reina Sofia /ID# 240322

๐Ÿ‡ช๐Ÿ‡ธ

Cordoba, Spain

Maharaj Nakorn Chiang Mai Hospital /ID# 240194

๐Ÿ‡น๐Ÿ‡ญ

Chiang Mai, Thailand

Eskisehir Osmangazi University Medical School /ID# 240225

๐Ÿ‡น๐Ÿ‡ท

Eskisehir, Turkey

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296

๐Ÿ‡น๐Ÿ‡ท

Istanbul, Turkey

Duplicate_NHS Lothian /ID# 240318

๐Ÿ‡ฌ๐Ÿ‡ง

Edinburgh, United Kingdom

Colorado Eye Institute /ID# 248910

๐Ÿ‡บ๐Ÿ‡ธ

Colorado Springs, Colorado, United States

Martel Eye Medical Group /ID# 240291

๐Ÿ‡บ๐Ÿ‡ธ

Rancho Cordova, California, United States

Levenson Eye Associates Inc. /ID# 240209

๐Ÿ‡บ๐Ÿ‡ธ

Jacksonville, Florida, United States

Tel Aviv Sourasky Medical Center /ID# 240311

๐Ÿ‡ฎ๐Ÿ‡ฑ

Tel Aviv, Tel-Aviv, Israel

Emory University /ID# 240328

๐Ÿ‡บ๐Ÿ‡ธ

Atlanta, Georgia, United States

Tekwani Vision Center /ID# 240220

๐Ÿ‡บ๐Ÿ‡ธ

Saint Louis, Missouri, United States

Vistar Eye Center /ID# 240198

๐Ÿ‡บ๐Ÿ‡ธ

Roanoke, Virginia, United States

Eye Specialty Group /ID# 240241

๐Ÿ‡บ๐Ÿ‡ธ

Memphis, Tennessee, United States

Hospital Universitario Austral /ID# 240331

๐Ÿ‡ฆ๐Ÿ‡ท

Pilar, Buenos Aires, Argentina

Ophthalmic Consultant Centres /ID# 240205

๐Ÿ‡จ๐Ÿ‡ฆ

Mississauga, Ontario, Canada

Rambam Health Care Campus /ID# 240332

๐Ÿ‡ฎ๐Ÿ‡ฑ

Haifa, H_efa, Israel

Cambridge University Hospitals NHS Foundation Trust /ID# 240351

๐Ÿ‡ฌ๐Ÿ‡ง

Cambridge, United Kingdom

Bnai Zion Medical Center /ID# 240297

๐Ÿ‡ฎ๐Ÿ‡ฑ

Haifa, H_efa, Israel

Hospital Clinico Universitario San Carlos /ID# 240303

๐Ÿ‡ช๐Ÿ‡ธ

Madrid, Spain

Keystone Research LTD /ID# 240185

๐Ÿ‡บ๐Ÿ‡ธ

Austin, Texas, United States

Oftalmologรญa Global /ID# 240244

๐Ÿ‡ฆ๐Ÿ‡ท

Rosario, Santa Fe, Argentina

Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634

๐Ÿ‡จ๐Ÿ‡ด

Bucaramanga, Santander, Colombia

Clinica de Oftalmologia Sandiego /ID# 240233

๐Ÿ‡จ๐Ÿ‡ด

Medellin, Antioquia, Colombia

Asian Eye Institute /ID# 240213

๐Ÿ‡ต๐Ÿ‡ญ

Makati City, Philippines

Universitair Ziekenhuis Leuven /ID# 240312

๐Ÿ‡ง๐Ÿ‡ช

Leuven, Vlaams-Brabant, Belgium

Arizona Glaucoma Specialists /ID# 240212

๐Ÿ‡บ๐Ÿ‡ธ

Phoenix, Arizona, United States

International Research Center /ID# 240346

๐Ÿ‡บ๐Ÿ‡ธ

Tampa, Florida, United States

James D Branch MD /ID# 240188

๐Ÿ‡บ๐Ÿ‡ธ

Winston-Salem, North Carolina, United States

Oklahoma Eye Surgeons /ID# 250430

๐Ÿ‡บ๐Ÿ‡ธ

Oklahoma City, Oklahoma, United States

Sacramento Eye Consultants /ID# 240263

๐Ÿ‡บ๐Ÿ‡ธ

Sacramento, California, United States

University of South Florida /ID# 250980

๐Ÿ‡บ๐Ÿ‡ธ

Tampa, Florida, United States

The Eye Care Institute /ID# 240289

๐Ÿ‡บ๐Ÿ‡ธ

Louisville, Kentucky, United States

Legacy Devers Eye Institute /ID# 240210

๐Ÿ‡บ๐Ÿ‡ธ

Portland, Oregon, United States

Tulane University /ID# 240327

๐Ÿ‡บ๐Ÿ‡ธ

New Orleans, Louisiana, United States

Montefiore Hospital /ID# 240324

๐Ÿ‡บ๐Ÿ‡ธ

Bronx, New York, United States

Walman Eye Center /ID# 240255

๐Ÿ‡บ๐Ÿ‡ธ

Sun City, Arizona, United States

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