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Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants 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
Active Comparator: Timolol 0.5%
Sham: Applicator Without Needle
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 in either eye within the first 52 weeks of the study duration
  • History of glaucoma surgery

Sites / Locations

  • Arizona Glaucoma Specialists
  • Lugene Eye Institute
  • Lakeside Vision Center
  • Hamilton Glaucoma Center, Shiley Eye Center UCSD
  • Atlantis Eye Care
  • Glaucoma Institute of Beverly Hills
  • Montebello Medical Eye Center Inc.
  • Stanford University
  • Foothill Eye Institute
  • Martel Eye Medical Group
  • Grutzmacher, Lewis and Sierra, Inc.
  • Pacific Eye Associates
  • Eye Associates of Colorado Springs
  • Palm Beach Eye Center, INC
  • Nature Coast Clinical Research
  • Levenson Eye Associates
  • East Florida Eye Institute
  • International Research Center
  • Coastal Research Associates, LLC
  • Chicago Eye Specialists
  • Indiana University School of Medicine
  • Heart of America Eye Care PA
  • Tulane Medical Center
  • Eye Doctors of Washington
  • MedRACS, LLC
  • Ocular Immunology and Uveitis Foundation
  • University of Michigan
  • Minnesota Eye Constultants, P.A.
  • Lifelong Vision Foundation
  • Moyes Eye Center, PC
  • Northern New Jersey Eye Institute P.A.
  • Eyecare Ophthalmology Associates, PC
  • Montefiore Medical Center
  • New York Eye and Ear Infirmary of Mount Sinai
  • Rochester Ophthalmological Group PC
  • 2000 North Village Avenue
  • Glaucoma Consultants of the Capital Region
  • 8 Medical Park Drive
  • Albemarle Clinical Trials, LLC
  • University Hospitals of Cleveland
  • The Ohio State University Havener Eye Institute
  • Drs Fine Hoffman & Sims, LLC
  • Wills Eye Institute - Glaucoma Research Center
  • Associates in Ophthalmology
  • Carolinas Centers for Sight PC
  • VRF Eye Specialty Group
  • Nashville Vision Associates
  • Keystone Research, LTD
  • Glaucoma Associates of Texas
  • The Cataract, Glaucoma & Refractive Surgery Center
  • Houston Eye Associates
  • Focal Point Vision
  • R and R Eye Research, LLC
  • Medical Center Ophthalmology Associates
  • Piedmont Eye Center
  • West Virginia University
  • Vision Eye Institute Chatswood
  • Melbourne Eye Specialists
  • Waverley Eye Clinic
  • Marsden Eye Specialists, Parramatta
  • Preston Eye Clinic
  • University of Graz
  • University of Vienna
  • University Hospitals Leuven
  • CHU Sart Tilman
  • Universidade Federal de Goias
  • Elo Oftalmologistas Associados
  • Nova Campinas Oftalmologia
  • Hospital Medicina dos Olhos
  • Hospital de Olhos MS
  • Escola Paulista de Medicina
  • Hospital das Clínicas - Faculdade de Medicina
  • Glostrup Hospital
  • Hong Kong Eye Hospital
  • The University of Hong Kong
  • Ganglion Medical Center
  • Markusovszky Korhaz
  • Zala Megyei Kórház
  • Barzilai Medical Center
  • Bnai Zion M.C.
  • Rambam Medical Center
  • Carmel Medical Center
  • Centro Oftalmológico Mácula Diagnóstico y Tratamiento
  • Asian Eye Institute
  • Pacific Eyecare & Laser Institute
  • Makati Medical Center
  • Prywatna Klinika Okulistyczna OFTALMIKA
  • Optimum Profesorskie Centrum Okulistyki
  • Public Clinical Hospital No. 1
  • ZOZ OKO- TEST Poradnia Okulistyczna
  • Diagnostic and Microsurgery Center of the Eye LENS
  • Retina Sp. z o.o
  • Klinika Okulistyki WIML
  • Uniwersytecki Szpital Kliniczny
  • Uniwersyteck Szpital Kliniczny
  • Institut Clinic d'Oftalmologia
  • Institut Catala de la Retina
  • Hospital General de Catalunya
  • Hospital Universitario Reina Sofía
  • Hospital Clinico San Carlos
  • Hospital Universitario Virgen Macarena
  • Hospital General
  • Hospital Universitario Rio Hortega
  • Hospital Universitario Miguel Servet
  • Buddhist Tzu Chi General Hospital (BTCGH)
  • Kaohsiung Veterans General Hospital

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%

Arm Description

Study 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.

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.

Study 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.

Outcomes

Primary Outcome Measures

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.
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 22, 2014
Last Updated
May 29, 2020
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02247804
Brief Title
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants 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
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 15, 2014 (Actual)
Primary Completion Date
February 19, 2018 (Actual)
Study Completion Date
July 19, 2019 (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 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.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
594 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimatoprost SR 15 μg
Arm Type
Experimental
Arm Description
Study 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.
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%
Arm Type
Active Comparator
Arm Description
Study 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.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost SR
Other Intervention Name(s)
AGN-192024
Intervention Description
Bimatoprost SR administered in the study eye 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
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)
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 IOP in the Study Eye at 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 (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 (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 in either eye within the first 52 weeks of the study duration History of glaucoma surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Bejanian
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Glaucoma Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91205
Country
United States
Facility Name
Lakeside Vision Center
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Facility Name
Hamilton Glaucoma Center, Shiley Eye Center UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Atlantis Eye Care
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Glaucoma Institute of Beverly Hills
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Montebello Medical Eye Center Inc.
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Foothill Eye Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Grutzmacher, Lewis and Sierra, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Pacific Eye Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Eye Associates of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Palm Beach Eye Center, INC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Nature Coast Clinical Research
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
International Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Coastal Research Associates, LLC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Chicago Eye Specialists
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60619
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Heart of America Eye Care PA
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Eye Doctors of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
MedRACS, LLC
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Ocular Immunology and Uveitis Foundation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Minnesota Eye Constultants, P.A.
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Moyes Eye Center, PC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Northern New Jersey Eye Institute P.A.
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079
Country
United States
Facility Name
Eyecare Ophthalmology Associates, PC
City
Bethpage
State/Province
New York
ZIP/Postal Code
11714
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York Eye and Ear Infirmary of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Rochester Ophthalmological Group PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
2000 North Village Avenue
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Glaucoma Consultants of the Capital Region
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
8 Medical Park Drive
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Albemarle Clinical Trials, LLC
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University Havener Eye Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Drs Fine Hoffman & Sims, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Wills Eye Institute - Glaucoma Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Associates in Ophthalmology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Carolinas Centers for Sight PC
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
VRF Eye Specialty Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Nashville Vision Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Keystone Research, LTD
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
The Cataract, Glaucoma & Refractive Surgery Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Focal Point Vision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
R and R Eye Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Vision Eye Institute Chatswood
City
Chatsworth
ZIP/Postal Code
New South Wales
Country
Australia
Facility Name
Melbourne Eye Specialists
City
Fitzroy
ZIP/Postal Code
Victoria 3065
Country
Australia
Facility Name
Waverley Eye Clinic
City
Glen Waverley
ZIP/Postal Code
Vctoria 3150
Country
Australia
Facility Name
Marsden Eye Specialists, Parramatta
City
Paramatta
ZIP/Postal Code
New South Wales
Country
Australia
Facility Name
Preston Eye Clinic
City
Preston
ZIP/Postal Code
Victoria 3072
Country
Australia
Facility Name
University of Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHU Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Universidade Federal de Goias
City
Goiania
State/Province
Goias
ZIP/Postal Code
74180-010
Country
Brazil
Facility Name
Elo Oftalmologistas Associados
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30140-090
Country
Brazil
Facility Name
Nova Campinas Oftalmologia
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13010-111
Country
Brazil
Facility Name
Hospital Medicina dos Olhos
City
Osasco
State/Province
Sao Paulo
ZIP/Postal Code
06010-130
Country
Brazil
Facility Name
Hospital de Olhos MS
City
Rio Verde
ZIP/Postal Code
79002-075
Country
Brazil
Facility Name
Escola Paulista de Medicina
City
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Hospital das Clínicas - Faculdade de Medicina
City
Sao Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Hong Kong Eye Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Ganglion Medical Center
City
Pecs
ZIP/Postal Code
H-7621
Country
Hungary
Facility Name
Markusovszky Korhaz
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Zala Megyei Kórház
City
Zalaegerszeg
ZIP/Postal Code
H-8900
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Bnai Zion M.C.
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Centro Oftalmológico Mácula Diagnóstico y Tratamiento
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Asian Eye Institute
City
Makati
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Pacific Eyecare & Laser Institute
City
Makati
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Makati Medical Center
City
Makati
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Prywatna Klinika Okulistyczna OFTALMIKA
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Optimum Profesorskie Centrum Okulistyki
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Public Clinical Hospital No. 1
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Facility Name
ZOZ OKO- TEST Poradnia Okulistyczna
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Diagnostic and Microsurgery Center of the Eye LENS
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
Facility Name
Retina Sp. z o.o
City
Warsaw
ZIP/Postal Code
01-364
Country
Poland
Facility Name
Klinika Okulistyki WIML
City
Warsaw
ZIP/Postal Code
01-755
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny
City
Warszawa
ZIP/Postal Code
01-755
Country
Poland
Facility Name
Uniwersyteck Szpital Kliniczny
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Institut Clinic d'Oftalmologia
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Institut Catala de la Retina
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Hospital General de Catalunya
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28004
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Hospital General
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Buddhist Tzu Chi General Hospital (BTCGH)
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan

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
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

Learn more about this trial

Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension

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