Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
2 other identifiers
interventional
594
13 countries
104
Brief Summary
This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2014
Longer than P75 for phase_3
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedStudy Start
First participant enrolled
December 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2019
CompletedResults Posted
Study results publicly available
April 24, 2020
CompletedJune 11, 2020
May 1, 2020
3.2 years
September 22, 2014
April 3, 2020
May 29, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)
IOP in the Study Eye at Week 2 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Week 2 (Hour 0)
IOP in the Study Eye at Week 2 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Week 2 (Hour 2)
IOP in the Study Eye at Week 6 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Week 6 (Hour 0)
IOP in the Study Eye at Week 6 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Week 6 (Hour 2)
IOP in the Study Eye at Week 12 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Week 12 (Hour 0)
IOP in the Study Eye at Week 12 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Week 12 (Hour 2)
Secondary Outcomes (1)
Change From Baseline in IOP in the Study Eye
Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)
Study Arms (3)
Bimatoprost SR 15 μg
EXPERIMENTALStudy Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Bimatoprost SR 10 μg
EXPERIMENTALStudy Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Timolol 0.5%
ACTIVE COMPARATORStudy Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Interventions
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Sham administered on Day 1, Week 16, and Week 32.
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Eligibility Criteria
You may qualify if:
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
You may not qualify if:
- Previous enrollment in another Allergan Bimatoprost SR Study.
- Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
- Anticipated need for laser eye surgery in either eye within the first 52 weeks of the study duration
- History of glaucoma surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (106)
Arizona Glaucoma Specialists
Phoenix, Arizona, 85050, United States
Lugene Eye Institute
Glendale, California, 91205, United States
Lakeside Vision Center
Irvine, California, 92604, United States
Hamilton Glaucoma Center, Shiley Eye Center UCSD
La Jolla, California, 92037, United States
Atlantis Eye Care
Long Beach, California, 90808, United States
Glaucoma Institute of Beverly Hills
Los Angeles, California, 90048, United States
Montebello Medical Eye Center Inc.
Montebello, California, 90640, United States
Stanford University
Palo Alto, California, 94303, United States
Foothill Eye Institute
Pasadena, California, 91107, United States
Martel Eye Medical Group
Rancho Cordova, California, 95670, United States
Grutzmacher, Lewis and Sierra, Inc.
Sacramento, California, 95815, United States
Pacific Eye Associates
San Francisco, California, 94115, United States
Eye Associates of Colorado Springs
Colorado Springs, Colorado, 80907, United States
Palm Beach Eye Center, INC
Atlantis, Florida, 33461, United States
Nature Coast Clinical Research
Crystal River, Florida, 34429, United States
Levenson Eye Associates
Jacksonville, Florida, 32204, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
International Research Center
Tampa, Florida, 33603, United States
Coastal Research Associates, LLC
Roswell, Georgia, 30076, United States
Chicago Eye Specialists
Chicago, Illinois, 60619, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Heart of America Eye Care PA
Shawnee Mission, Kansas, 66204, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
Eye Doctors of Washington
Chevy Chase, Maryland, 20815, United States
MedRACS, LLC
Quincy, Massachusetts, 02169, United States
Ocular Immunology and Uveitis Foundation
Waltham, Massachusetts, 02451, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Minnesota Eye Constultants, P.A.
Bloomington, Minnesota, 55431, United States
Lifelong Vision Foundation
Chesterfield, Missouri, 63017, United States
Moyes Eye Center, PC
Kansas City, Missouri, 64154, United States
Northern New Jersey Eye Institute P.A.
South Orange, New Jersey, 07079, United States
Eyecare Ophthalmology Associates, PC
Bethpage, New York, 11714, United States
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003, United States
Rochester Ophthalmological Group PC
Rochester, New York, 14618, United States
2000 North Village Avenue
Rockville Centre, New York, 11570, United States
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
8 Medical Park Drive
Asheville, North Carolina, 28803, United States
Albemarle Clinical Trials, LLC
Elizabeth City, North Carolina, 27909, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
The Ohio State University Havener Eye Institute
Columbus, Ohio, 43212, United States
Drs Fine Hoffman & Sims, LLC
Eugene, Oregon, 97401, United States
Wills Eye Institute - Glaucoma Research Center
Philadelphia, Pennsylvania, 19107, United States
Associates in Ophthalmology
Pittsburgh, Pennsylvania, 15219, United States
Carolinas Centers for Sight PC
Florence, South Carolina, 29501, United States
VRF Eye Specialty Group
Memphis, Tennessee, 38120, United States
Nashville Vision Associates
Nashville, Tennessee, 37205, United States
Keystone Research, LTD
Austin, Texas, 78731, United States
Glaucoma Associates of Texas
Dallas, Texas, 75231, United States
The Cataract, Glaucoma & Refractive Surgery Center
El Paso, Texas, 79902, United States
Houston Eye Associates
Houston, Texas, 77025, United States
Focal Point Vision
San Antonio, Texas, 78229, United States
R and R Eye Research, LLC
San Antonio, Texas, 78234, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Vision Eye Institute Chatswood
Chatsworth, New South Wales, Australia
Melbourne Eye Specialists
Fitzroy, Victoria 3065, Australia
Waverley Eye Clinic
Glen Waverley, Vctoria 3150, Australia
Marsden Eye Specialists, Parramatta
Paramatta, New South Wales, Australia
Preston Eye Clinic
Preston, Victoria 3072, Australia
University of Graz
Graz, A-8036, Austria
University of Vienna
Vienna, 1090, Austria
University Hospitals Leuven
Leuven, B-3000, Belgium
CHU Sart Tilman
Liège, 4000, Belgium
Universidade Federal de Goias
Goiânia, Goiás, 74180-010, Brazil
Elo Oftalmologistas Associados
Belo Horizonte, Minas Gerais, 30140-090, Brazil
Nova Campinas Oftalmologia
Campinas, São Paulo, 13010-111, Brazil
Hospital Medicina dos Olhos
Osasco, São Paulo, 06010-130, Brazil
Hospital de Olhos MS
Rio Verde, 79002-075, Brazil
Escola Paulista de Medicina
São Paulo, 04023-062, Brazil
Hospital das Clínicas - Faculdade de Medicina
São Paulo, 14049-900, Brazil
Glostrup Hospital
Glostrup Municipality, 2600, Denmark
Hong Kong Eye Hospital
Hong Kong, Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
Ganglion Medical Center
Pécs, H-7621, Hungary
Markusovszky Korhaz
Szombathely, H-9700, Hungary
Zala Megyei Kórház
Zalaegerszeg, H-8900, Hungary
Barzilai Medical Center
Ashkelon, 78278, Israel
Bnai Zion M.C.
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 31096, Israel
Carmel Medical Center
Haifa, 34362, Israel
Centro Oftalmológico Mácula Diagnóstico y Tratamiento
Lima, Lima 27, Peru
Asian Eye Institute
Makati, 1200, Philippines
Pacific Eyecare & Laser Institute
Makati, 1200, Philippines
Makati Medical Center
Makati, 1229, Philippines
Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, 85-631, Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-211, Poland
Public Clinical Hospital No. 1
Lublin, 20-079, Poland
ZOZ OKO- TEST Poradnia Okulistyczna
Nowy Targ, 34-400, Poland
Diagnostic and Microsurgery Center of the Eye LENS
Olsztyn, 10-424, Poland
Retina Sp. z o.o
Warsaw, 01-364, Poland
Klinika Okulistyki WIML
Warsaw, 01-755, Poland
Uniwersytecki Szpital Kliniczny
Warsaw, 01-755, Poland
Uniwersyteck Szpital Kliniczny
Wroclaw, 50-368, Poland
Institut Clinic d'Oftalmologia
Barcelona, 08006, Spain
Institut Catala de la Retina
Barcelona, 08017, Spain
Hospital General de Catalunya
Barcelona, 08195, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Clinico San Carlos
Madrid, 28004, Spain
Hospital Universitario Virgen Macarena
Seville, 41071, Spain
Hospital General
Valencia, 46017, Spain
Hospital Universitario Rio Hortega
Valladolid, 47012, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Buddhist Tzu Chi General Hospital (BTCGH)
Hualien City, Hualien, 970, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Related Publications (2)
Weinreb RN, Bacharach J, Brubaker JW, Medeiros FA, Bejanian M, Bernstein P, Robinson MR. Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):55-62. doi: 10.1089/jop.2022.0137. Epub 2022 Nov 15.
PMID: 36378864DERIVEDMedeiros FA, Sheybani A, Shah MM, Rivas M, Bai Z, Werts E, Ahmed IIK, Craven ER. Single Administration of Intracameral Bimatoprost Implant 10 microg in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.
PMID: 35643967DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Marina Bejanian
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2014
First Posted
September 25, 2014
Study Start
December 15, 2014
Primary Completion
February 19, 2018
Study Completion
July 19, 2019
Last Updated
June 11, 2020
Results First Posted
April 24, 2020
Record last verified: 2020-05