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

May 29, 2020 updated by: Allergan

The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

594

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bimatoprost SR 15 μg
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.
Drug: Bimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Other Names:
  • AGN-192024
Drug: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Other: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Drug: Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Experimental: Bimatoprost SR 10 μg
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.
Drug: Bimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Other Names:
  • AGN-192024
Drug: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Other: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Drug: Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Active Comparator: Timolol 0.5%
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.
Drug: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Other: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)
Time Frame: Baseline (Hours 0 and 2) 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.
Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)
IOP in the Study Eye at Week 2 (Hour 0)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in IOP in the Study Eye
Time Frame: Baseline (Hours 0 and 2) to Weeks 2 and 6 (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. 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 Weeks 2 and 6 (Hours 0 and 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Marina Bejanian, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2014

Primary Completion (Actual)

February 19, 2018

Study Completion (Actual)

July 19, 2019

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192024-091
  • 2014-003037-26 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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