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Glaucoma, Open-AnglePhase 3NCT02250651

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

A Phase 3 study testing Bimatoprost SR and Active Comparator: Timolol 0.5% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 113 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma, Open-Angle, Ocular Hypertension
What is being tested?
Bimatoprost SR and Active Comparator: Timolol 0.5%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
528 participants
Where
113 sitesin 15 countries
Study dates
15 Dec 2014to 22 Jul 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

113 sites in 15 countries.

113 sites in 15 countries

United States51 sites

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Lehigh Valley Eye Center, P.C.

    Allentown, Pennsylvania, 18104

  • Emory University Eye Center

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • Johns Hopkins School of Medicine, Wilmer Eye Institute

    Baltimore, Maryland, 21287

  • Specialty Eyecare Centre

    Bellevue, Washington, 98004

  • Argus Research at Cape Coral Eye Center

    Cape Coral, Florida, 33904

  • Arizona Eye Center

    Chandler, Arizona, 85224

  • Charlotte Eye Ear Nose & Throat Associates, PA

    Charlotte, North Carolina, 28210

  • Specialty Retinal Center

    Coral Springs, Florida, 33067

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania, 16006

  • Danbury Eye Physicians and Surgeons PC

    Danbury, Connecticut, 06810

  • Bruce A Segal, M.D.

    Delray Beach, Florida, 33484

  • Eye Center South

    Dothan, Alabama, 36301

  • Bergstrom Eye and Laser Clinic

    Fargo, North Dakota, 58103

  • Vold Vision

    Fayetteville, Arkansas, 72704

  • Eye Associates of Fort Myers

    Fort Myers, Florida, 33901

  • Eye Clinic at Shands Medical Plaza

    Gainesville, Florida, 32608

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Mark B. Kislinger, MD, Inc.

    Glendora, California, 91741

  • Inland Eye Specialists

    Hemet, California, 92545

  • Alkek Eye Center

    Houston, Texas, 77030

  • Southern California Eye Physicians and Surgeons

    Los Alamitos, California, 90720

  • Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex

    Louisville, Kentucky, 40215

  • DCT-Shah Research, LLC dba Discovery ClinicalTrials

    Mission, Texas, 78572

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Rutgers-New Jersey Medical School

    Newark, New Jersey, 07103

  • Eye Research Foundation

    Newport Beach, California, 92663

  • Bascom Palmer Eye Institute, University of Miami

    Palm Beach Gardens, Florida, 33418

  • Insight Vision Group

    Parker, Colorado, 80134

  • North Bay Eye Associates, Inc.

    Petaluma, California, 94954

  • Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Key Whitman Eye Center

    Plano, Texas, 75093

  • Legacy Good Samaritan Hospital - Devers Eye Institute

    Portland, Oregon, 97210

  • Alterman, Modi & Wolter

    Poughkeepsie, New York, 12603

  • The Eye Centers of Racine and Kenosha

    Racine, Wisconsin, 53405

  • Shasta Eye Medical Group, Inc.

    Redding, California, 96002

  • Vistar Eye Center

    Roanoke, Virginia, 24016

  • Virdi Eye Clinic

    Rock Island, Illinois, 61201

  • University of California (UCSF) Department of Ophthalmology

    San Francisco, California, 94143

  • Pacific Eye Surgeons

    San Luis Obispo, California, 93401

  • Shepard Eye Center

    Santa Maria, California, 93454

  • Center for Sight

    Sarasota, Florida, 34239

  • MedEye Associates

    South Miami, Florida, 33143-3693

  • Tekwani Vision Center

    St Louis, Missouri, 63128

  • East West Eye Institute

    Torrance, California, 90505

  • Wolstan & Goldberg Eye Associates

    Torrance, California, 90505

  • South Shore Eye Care, LLP

    Wantagh, New York, 11793

  • Wenatchee valley Hospital & Clinics, Clinical research department

    Wenatchee, Washington, 98801

  • Clinical Eye Research of Boston, Co.

    Winchester, Massachusetts, 01890

  • James D. Branch, MD

    Winston-Salem, North Carolina, 27101

Other trials in United States

Canada11 sites

  • Trimed Eye Center

    Barrie, Ontario, L4M455

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec, J7J 2BJ

  • ACS Crichton Prof. Corp

    Calgary, Alberta, T3E-7M8

  • Uptown Eye Specialists

    Concord, Ontario, L4K225

  • Clinique d' ophtalmologie Dr Saurel

    Drummondville, Quebec, J2C 2C4

  • Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences

    Halifax, Nova Scotia, B3H 2Y9

  • Galen Eye Centre

    Kingston, Ontario, K7K 6Z6

  • Ophthalmic Consultant Centres Inc

    Mississauga, Ontario, L4W1W9

  • Bellevue Clinic

    Montreal, Quebec, H1V 1GS

  • GOGiunta Ophtalmologie

    Sherbrooke, Quebec, J1G 2V4

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N3M5

Other trials in Canada

United Kingdom9 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Queen Alexandra Hospital

    Cosham, PO6 3LY

  • Princess Alexandra Eye Pavilion

    Edinburgh, EH3 9HA

  • James Paget University Hosp NHS Foundation Trust

    Great Yarmouth, NR31 6LA

  • St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust

    Liverpool, L7 8XP

  • Aintree University Hospital NHS Foundation Trust

    Liverpool, L9 7AL

  • ICORG

    London, 153-173

  • In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital

    London, SE1 7EH

  • Peterborough City Hospital Research and Development Department

    Peterborough, PE39GZ

Other trials in United Kingdom

Argentina8 sites

  • Instituto Oftalmologico de Buenos Aires Oftalmos

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1120AAN

  • Hospital Italiano de Buenos Aires - Hospital

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1181ACH

  • Organización Médica de Investigación

    Ciudad Autónoma de BuenosAires, C1015ABO

  • Clinica Privada de Ojos

    Mar del Plata, Buenos Aires, 7600

  • Oftar Centro Privado de Oftalmologia

    Mendoza, 5500

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT

  • Centro Medico Oftalmologia Global

    Rosario, Santa Fe Province, 2000

  • Centro Médico Grupo Laser Visión

    Rosario, Santa Fe Province, S2000AZH

Other trials in Argentina

Italy6 sites

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, Sicily, 95123

  • Università degli Studi G. D'Annunzio Chieti-Pescara

    Chieti, Abruzzo, 66013

  • Azienda Ospedaliera-Polo Universitario San Paolo

    Milan, Lombardy, 20142

  • Unità Operativa di Oculistica Ospedale San Raffaele S.r.l.

    Milan, 20132

  • Ospedale Santa Maria Della Misericordia

    Perugia, 06156

  • Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa

    Pisa, Tuscany, 56124

Other trials in Italy

Germany5 sites

  • Augen Zentrum Nordwest

    Ahaus, North Rhine-Westphalia, 48683

  • Universitätsklinik Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

  • Klinisches Studienzentrum

    Mainz, 55131

  • Augenärzte am St. Franziskus-Hospital

    Münster, North Rhine-Westphalia, 48145

  • Klinikum der Universität Regensburg

    Regensburg, Bavaria, 93053

Other trials in Germany

Colombia4 sites

  • Fundación Oftalmologica Nacional Fundonal

    Bogotá, Bogota D.C., 110231

  • Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A.

    Cali, 760001

  • Fundacion Oftalmologica de Santander Foscal

    Floridablanca, Santander Department, 680004

  • Clinica de Oftalmologia Sandiego S.A.

    Medellín, Antioquia, 0000

Other trials in Colombia

Czechia3 sites

  • Ocni klinika

    Brno, Jihlavska, 62500

  • Nemocnicni Lekarna

    Hradec Králové, Sokolska, 50005

  • Ocni klinika Pardubice

    Prague, 53002

Other trials in Czechia

Egypt3 sites

  • Al Kasr Al Ainy Cairo University Hospital

    Cairo, 11562

  • Ain Shams University Hospital

    Cairo, 11566

  • Menoufia University Hospital

    Shibīn al-Kawm, Cairo Governorate, 32111

Other trials in Egypt

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • Singapore National Eye Centre

    Singapore, 168751

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 110744

  • Samsung Medical Center

    Seoul, 135710

  • Asan Medical Center

    Seoul, 138736

Other trials in South Korea

Turkey (Türkiye)3 sites

  • Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali

    Manisa, 45030

  • Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali

    Meselik, Eskişehir, 26480

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari

    Pendik, Istanbul, 34890

Other trials in Turkey (Türkiye)

South Africa2 sites

  • Pretoria Eye Institute

    Arcadia, Pretoria, 0083

  • Horizon Eye Care Centre

    Bloemfontein, Free State, 9301

Other trials in South Africa

Malaysia1 site

  • Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology

    Cheras, Kuala Lumpur, 50586

Other trials in Malaysia

New Zealand1 site

  • Capital Eye Specialists

    Wellington, 06011

Other trials in New Zealand

About this study

Official title: 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 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.

Being tested
Bimatoprost SR, Sham: Applicator Without Needle, Active Comparator: Timolol 0.5%, Timolol Vehicle (placebo)
Medical subject headings
Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bimatoprost SRDrug

    Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.

  • Sham: Applicator Without NeedleOther

    Sham administered on Day 1, Week 16, and Week 32.

  • Active Comparator: Timolol 0.5%Drug

    Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

  • Timolol Vehicle (placebo)Drug

    Timolol vehicle administered once in the morning and once in the evening for up to 20 months.

Study groups in NCT02250651
Study groupRoleWhat they receive
Bimatoprost SR 15 μgExperimentalStudy 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.
Receives: Drug: Bimatoprost SR; Other: Sham: Applicator Without Needle; Drug: Active Comparator: Timolol 0.5%; Drug: Timolol Vehicle (placebo)
Bimatoprost SR 10 μgExperimentalStudy 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.
Receives: Drug: Bimatoprost SR; Other: Sham: Applicator Without Needle; Drug: Active Comparator: Timolol 0.5%; Drug: Timolol Vehicle (placebo)
Timolol 0.5%: ComparatorActive comparatorBoth 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.
Receives: Other: Sham: Applicator Without Needle; Drug: Active Comparator: Timolol 0.5%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)

  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.

    Measured: Week 2 (Hour 0)

  3. 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.

    Measured: Week 2 (Hour 2)

  4. 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.

    Measured: Week 6 (Hour 0)

  5. 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.

    Measured: Week 6 (Hour 2)

  6. 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.

    Measured: Week 12 (Hour 0)

  7. 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.

    Measured: Week 12 (Hour 2)

Secondary outcomes (1)

  1. 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.

    Measured: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2014 (estimated)
  2. Study start15 Dec 2014
  3. Primary completion25 Oct 2018
  4. Study completion22 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
528 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02250651
Sponsor's protocol ID
192024-092
Other IDs
2014-003186-24, 2014
Status last verified
Jun 2021
First submitted
23 Sep 2014
Last updated
28 Jul 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 36378864

  • 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.

    PubMed 35643967

  • 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.

    PubMed 34724172

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimatoprost SR and Active Comparator: Timolol 0.5% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 113 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Canada, United Kingdom, Argentina, Italy and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) (time frame: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02250651, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.

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