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Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimatoprost SR
Sham: Applicator Without Needle
Active Comparator: Timolol 0.5%
Timolol Vehicle (placebo)
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.

Exclusion Criteria:

  • 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 within the first 52 weeks of the study duration
  • History of glaucoma surgery

Sites / Locations

  • Eye Center South
  • Arizona Eye Center
  • Vold Vision
  • Mark B. Kislinger, MD, Inc.
  • Inland Eye Specialists
  • Southern California Eye Physicians and Surgeons
  • Eye Research Foundation
  • North Bay Eye Associates, Inc.
  • Shasta Eye Medical Group, Inc.
  • University of California (UCSF) Department of Ophthalmology
  • Pacific Eye Surgeons
  • Shepard Eye Center
  • East West Eye Institute
  • Wolstan & Goldberg Eye Associates
  • University of Colorado
  • Insight Vision Group
  • Danbury Eye Physicians and Surgeons PC
  • Argus Research at Cape Coral Eye Center
  • Specialty Retinal Center
  • Bruce A Segal, M.D.
  • Eye Associates of Fort Myers
  • Eye Clinic at Shands Medical Plaza
  • Bascom Palmer Eye Institute, University of Miami
  • Center for Sight
  • MedEye Associates
  • Emory University Eye Center
  • Virdi Eye Clinic
  • Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex
  • Johns Hopkins School of Medicine, Wilmer Eye Institute
  • Clinical Eye Research of Boston, Co.
  • Tekwani Vision Center
  • Rutgers-New Jersey Medical School
  • Eye Associates of New Mexico
  • Mount Sinai School of Medicine
  • Alterman, Modi & Wolter
  • South Shore Eye Care, LLP
  • Charlotte Eye Ear Nose & Throat Associates, PA
  • James D. Branch, MD
  • Bergstrom Eye and Laser Clinic
  • Legacy Good Samaritan Hospital - Devers Eye Institute
  • Lehigh Valley Eye Center, P.C.
  • Scott & Christie and Associates, PC
  • Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania
  • University of Texas Medical Branch
  • Alkek Eye Center
  • DCT-Shah Research, LLC dba Discovery ClinicalTrials
  • Key Whitman Eye Center
  • Vistar Eye Center
  • Specialty Eyecare Centre
  • Wenatchee valley Hospital & Clinics, Clinical research department
  • The Eye Centers of Racine and Kenosha
  • Instituto Oftalmologico de Buenos Aires Oftalmos
  • Hospital Italiano de Buenos Aires - Hospital
  • Clinica Privada de Ojos
  • Hospital Universitario Austral
  • Centro Medico Oftalmologia Global
  • Centro Médico Grupo Laser Visión
  • Organización Médica de Investigación
  • Oftar Centro Privado de Oftalmologia
  • ACS Crichton Prof. Corp
  • Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences
  • Trimed Eye Center
  • Uptown Eye Specialists
  • Galen Eye Centre
  • Ophthalmic Consultant Centres Inc
  • Sunnybrook Research Institute
  • Institut De L'Oeil Des Laurentides
  • Clinique d' ophtalmologie Dr Saurel
  • Bellevue Clinic
  • GOGiunta Ophtalmologie
  • Clinica de Oftalmologia Sandiego S.A.
  • Fundación Oftalmologica Nacional Fundonal
  • Fundacion Oftalmologica de Santander Foscal
  • Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A.
  • Ocni klinika
  • Nemocnicni Lekarna
  • Ocni klinika Pardubice
  • Menoufia University Hospital
  • Al Kasr Al Ainy Cairo University Hospital
  • Ain Shams University Hospital
  • Klinikum der Universität Regensburg
  • Augen Zentrum Nordwest
  • Augenärzte am St. Franziskus-Hospital
  • Universitätsklinik Magdeburg
  • Klinisches Studienzentrum
  • Università degli Studi G. D'Annunzio Chieti-Pescara
  • Azienda Ospedaliera-Polo Universitario San Paolo
  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
  • Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
  • Unità Operativa di Oculistica Ospedale San Raffaele S.r.l.
  • Ospedale Santa Maria Della Misericordia
  • Seoul National University Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology
  • Capital Eye Specialists
  • National University Hospital
  • Singapore National Eye Centre
  • Changi General Hospital
  • Horizon Eye Care Centre
  • Pretoria Eye Institute
  • Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali
  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari
  • Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali
  • Addenbrookes Hospital
  • Queen Alexandra Hospital
  • Princess Alexandra Eye Pavilion
  • James Paget University Hosp NHS Foundation Trust
  • St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust
  • Aintree University Hospital NHS Foundation Trust
  • ICORG
  • In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital
  • Peterborough City Hospital Research and Development Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Bimatoprost SR 15 μg

Bimatoprost SR 10 μg

Timolol 0.5%: Comparator

Arm Description

Study Eye: bimatoprost sustained-release (SR) 15 micrograms (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.

Study 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.

Both Eyes: 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.

Outcomes

Primary Outcome Measures

Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to 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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Change From Baseline in IOP in the Study Eye
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. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Full Information

First Posted
September 23, 2014
Last Updated
July 6, 2021
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02250651
Brief Title
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2014 (Actual)
Primary Completion Date
October 25, 2018 (Actual)
Study Completion Date
July 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
528 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimatoprost SR 15 μg
Arm Type
Experimental
Arm Description
Study Eye: bimatoprost sustained-release (SR) 15 micrograms (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.
Arm Title
Bimatoprost SR 10 μg
Arm Type
Experimental
Arm Description
Study 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.
Arm Title
Timolol 0.5%: Comparator
Arm Type
Active Comparator
Arm Description
Both Eyes: 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.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost SR
Intervention Description
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Intervention Type
Other
Intervention Name(s)
Sham: Applicator Without Needle
Intervention Description
Sham administered on Day 1, Week 16, and Week 32.
Intervention Type
Drug
Intervention Name(s)
Active Comparator: Timolol 0.5%
Intervention Description
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Intervention Type
Drug
Intervention Name(s)
Timolol Vehicle (placebo)
Intervention Description
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Primary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)
Description
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.
Time Frame
Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)
Title
IOP in the Study Eye at Week 2 (Hour 0)
Description
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.
Time Frame
Week 2 (Hour 0)
Title
IOP in the Study Eye at Week 2 (Hour 2)
Description
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.
Time Frame
Week 2 (Hour 2)
Title
IOP in the Study Eye at Week 6 (Hour 0)
Description
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.
Time Frame
Week 6 (Hour 0)
Title
IOP in the Study Eye at Week 6 (Hour 2)
Description
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.
Time Frame
Week 6 (Hour 2)
Title
IOP in the Study Eye at Week 12 (Hour 0)
Description
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.
Time Frame
Week 12 (Hour 0)
Title
IOP in the Study Eye at Week 12 (Hour 2)
Description
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.
Time Frame
Week 12 (Hour 2)
Secondary Outcome Measure Information:
Title
Change From Baseline in IOP in the Study Eye
Description
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. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time Frame
Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment. Exclusion Criteria: 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 within the first 52 weeks of the study duration History of glaucoma surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margot Goodkin
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Eye Center South
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Facility Name
Mark B. Kislinger, MD, Inc.
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
Inland Eye Specialists
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
Southern California Eye Physicians and Surgeons
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
North Bay Eye Associates, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Shasta Eye Medical Group, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96002
Country
United States
Facility Name
University of California (UCSF) Department of Ophthalmology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Pacific Eye Surgeons
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Shepard Eye Center
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
East West Eye Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Insight Vision Group
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Danbury Eye Physicians and Surgeons PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Argus Research at Cape Coral Eye Center
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
Facility Name
Specialty Retinal Center
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Bruce A Segal, M.D.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Eye Associates of Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Eye Clinic at Shands Medical Plaza
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Bascom Palmer Eye Institute, University of Miami
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
Facility Name
Center for Sight
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
MedEye Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143-3693
Country
United States
Facility Name
Emory University Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Virdi Eye Clinic
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Facility Name
Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Johns Hopkins School of Medicine, Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Clinical Eye Research of Boston, Co.
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Rutgers-New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Alterman, Modi & Wolter
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
South Shore Eye Care, LLP
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
James D. Branch, MD
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Bergstrom Eye and Laser Clinic
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Legacy Good Samaritan Hospital - Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Lehigh Valley Eye Center, P.C.
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16006
Country
United States
Facility Name
Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Alkek Eye Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
DCT-Shah Research, LLC dba Discovery ClinicalTrials
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States
Facility Name
Key Whitman Eye Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Vistar Eye Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Specialty Eyecare Centre
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Wenatchee valley Hospital & Clinics, Clinical research department
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
The Eye Centers of Racine and Kenosha
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
Facility Name
Instituto Oftalmologico de Buenos Aires Oftalmos
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1120AAN
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires - Hospital
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Clinica Privada de Ojos
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
Facility Name
Centro Medico Oftalmologia Global
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro Médico Grupo Laser Visión
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000AZH
Country
Argentina
Facility Name
Organización Médica de Investigación
City
Ciudad Autónoma de BuenosAires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Oftar Centro Privado de Oftalmologia
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
ACS Crichton Prof. Corp
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E-7M8
Country
Canada
Facility Name
Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Trimed Eye Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M455
Country
Canada
Facility Name
Uptown Eye Specialists
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K225
Country
Canada
Facility Name
Galen Eye Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7K 6Z6
Country
Canada
Facility Name
Ophthalmic Consultant Centres Inc
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W1W9
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Institut De L'Oeil Des Laurentides
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7J 2BJ
Country
Canada
Facility Name
Clinique d' ophtalmologie Dr Saurel
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2C 2C4
Country
Canada
Facility Name
Bellevue Clinic
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1V 1GS
Country
Canada
Facility Name
GOGiunta Ophtalmologie
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2V4
Country
Canada
Facility Name
Clinica de Oftalmologia Sandiego S.A.
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Fundación Oftalmologica Nacional Fundonal
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110231
Country
Colombia
Facility Name
Fundacion Oftalmologica de Santander Foscal
City
Floridablanca
State/Province
Santander
ZIP/Postal Code
680004
Country
Colombia
Facility Name
Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A.
City
Cali
ZIP/Postal Code
760001
Country
Colombia
Facility Name
Ocni klinika
City
Brno
State/Province
Jihlavska
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Nemocnicni Lekarna
City
Hradec Kralove
State/Province
Sokolska
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Ocni klinika Pardubice
City
Prague
ZIP/Postal Code
53002
Country
Czechia
Facility Name
Menoufia University Hospital
City
Shibīn al-Kawm
State/Province
Cairo
ZIP/Postal Code
32111
Country
Egypt
Facility Name
Al Kasr Al Ainy Cairo University Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Facility Name
Ain Shams University Hospital
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Facility Name
Klinikum der Universität Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Augen Zentrum Nordwest
City
Ahaus
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48683
Country
Germany
Facility Name
Augenärzte am St. Franziskus-Hospital
City
Munster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
Facility Name
Universitätsklinik Magdeburg
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Klinisches Studienzentrum
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Università degli Studi G. D'Annunzio Chieti-Pescara
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66013
Country
Italy
Facility Name
Azienda Ospedaliera-Polo Universitario San Paolo
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
Unità Operativa di Oculistica Ospedale San Raffaele S.r.l.
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale Santa Maria Della Misericordia
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138736
Country
Korea, Republic of
Facility Name
Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Capital Eye Specialists
City
Wellington
ZIP/Postal Code
06011
Country
New Zealand
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Horizon Eye Care Centre
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Pretoria Eye Institute
City
Arcadia
State/Province
Pretoria
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali
City
Meselik
State/Province
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari
City
Pendik
State/Province
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali
City
Manisa
ZIP/Postal Code
45030
Country
Turkey
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Cosham
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Princess Alexandra Eye Pavilion
City
Edinburgh
ZIP/Postal Code
EH3 9HA
Country
United Kingdom
Facility Name
James Paget University Hosp NHS Foundation Trust
City
Great Yarmouth
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Aintree University Hospital NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
ICORG
City
London
ZIP/Postal Code
153-173
Country
United Kingdom
Facility Name
In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Peterborough City Hospital Research and Development Department
City
Peterborough
ZIP/Postal Code
PE39GZ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36378864
Citation
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.
Results Reference
derived
PubMed Identifier
35643967
Citation
Medeiros 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.
Results Reference
derived
PubMed Identifier
34724172
Citation
Bacharach J, Tatham A, Ferguson G, Belalcazar S, Thieme H, Goodkin ML, Chen MY, Guo Q, Liu J, Robinson MR, Bejanian M, Wirta DL; ARTEMIS 2 Study Group. Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2). Drugs. 2021 Nov;81(17):2017-2033. doi: 10.1007/s40265-021-01624-9. Epub 2021 Nov 1.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

Learn more about this trial

Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension

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