Glaucoma, Open-AnglePhase 3NCT02247804
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants 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 106 sites in 14 countries.
Trial 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. 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
- 594 participants
- Where
- 106 sitesin 14 countries
- Study dates
- 15 Dec 2014to 19 Jul 2019
- 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 in either eye within the first 52 weeks of the study duration
- History of glaucoma surgery
Trial locations and contacts
106 sites in 14 countries.
106 sites in 14 countries
United States56 sites
University of Michigan
Ann Arbor, Michigan, 48109
8 Medical Park Drive
Asheville, North Carolina, 28803
Palm Beach Eye Center, INC
Atlantis, Florida, 33461
Keystone Research, LTD
Austin, Texas, 78731
Eyecare Ophthalmology Associates, PC
Bethpage, New York, 11714
Minnesota Eye Constultants, P.A.
Bloomington, Minnesota, 55431
Lifelong Vision Foundation
Chesterfield, Missouri, 63017
Eye Doctors of Washington
Chevy Chase, Maryland, 20815
Chicago Eye Specialists
Chicago, Illinois, 60619
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Eye Associates of Colorado Springs
Colorado Springs, Colorado, 80907
The Ohio State University Havener Eye Institute
Columbus, Ohio, 43212
Nature Coast Clinical Research
Crystal River, Florida, 34429
Glaucoma Associates of Texas
Dallas, Texas, 75231
The Cataract, Glaucoma & Refractive Surgery Center
El Paso, Texas, 79902
Albemarle Clinical Trials, LLC
Elizabeth City, North Carolina, 27909
Drs Fine Hoffman & Sims, LLC
Eugene, Oregon, 97401
Carolinas Centers for Sight PC
Florence, South Carolina, 29501
Lugene Eye Institute
Glendale, California, 91205
Houston Eye Associates
Houston, Texas, 77025
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Lakeside Vision Center
Irvine, California, 92604
Levenson Eye Associates
Jacksonville, Florida, 32204
Moyes Eye Center, PC
Kansas City, Missouri, 64154
Hamilton Glaucoma Center, Shiley Eye Center UCSD
La Jolla, California, 92037
Atlantis Eye Care
Long Beach, California, 90808
Glaucoma Institute of Beverly Hills
Los Angeles, California, 90048
Piedmont Eye Center
Lynchburg, Virginia, 24502
VRF Eye Specialty Group
Memphis, Tennessee, 38120
Montebello Medical Eye Center Inc.
Montebello, California, 90640
West Virginia University
Morgantown, West Virginia, 26506
Nashville Vision Associates
Nashville, Tennessee, 37205
Tulane Medical Center
New Orleans, Louisiana, 70112
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
Stanford University
Palo Alto, California, 94303
Foothill Eye Institute
Pasadena, California, 91107
Wills Eye Institute - Glaucoma Research Center
Philadelphia, Pennsylvania, 19107
Arizona Glaucoma Specialists
Phoenix, Arizona, 85050
Associates in Ophthalmology
Pittsburgh, Pennsylvania, 15219
MedRACS, LLC
Quincy, Massachusetts, 02169
Martel Eye Medical Group
Rancho Cordova, California, 95670
Rochester Ophthalmological Group PC
Rochester, New York, 14618
2000 North Village Avenue
Rockville Centre, New York, 11570
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Grutzmacher, Lewis and Sierra, Inc.
Sacramento, California, 95815
Focal Point Vision
San Antonio, Texas, 78229
R and R Eye Research, LLC
San Antonio, Texas, 78234
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Pacific Eye Associates
San Francisco, California, 94115
Heart of America Eye Care PA
Shawnee Mission, Kansas, 66204
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159
Northern New Jersey Eye Institute P.A.
South Orange, New Jersey, 07079
East Florida Eye Institute
Stuart, Florida, 34994
International Research Center
Tampa, Florida, 33603
Montefiore Medical Center
The Bronx, New York, 10467
Ocular Immunology and Uveitis Foundation
Waltham, Massachusetts, 02451
Poland9 sites
Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, 85-631
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-211
Public Clinical Hospital No. 1
Lublin, 20-079
ZOZ OKO- TEST Poradnia Okulistyczna
Nowy Targ, 34-400
Diagnostic and Microsurgery Center of the Eye LENS
Olsztyn, 10-424
Retina Sp. z o.o
Warsaw, 01-364
Klinika Okulistyki WIML
Warsaw, 01-755
Uniwersytecki Szpital Kliniczny
Warsaw, 01-755
Uniwersyteck Szpital Kliniczny
Wroclaw, 50-368
Spain9 sites
Institut Clinic d'Oftalmologia
Barcelona, 08006
Institut Catala de la Retina
Barcelona, 08017
Hospital General de Catalunya
Barcelona, 08195
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital Clinico San Carlos
Madrid, 28004
Hospital Universitario Virgen Macarena
Seville, 41071
Hospital General
Valencia, 46017
Hospital Universitario Rio Hortega
Valladolid, 47012
Hospital Universitario Miguel Servet
Zaragoza, 50009
Brazil7 sites
Elo Oftalmologistas Associados
Belo Horizonte, Minas Gerais, 30140-090
Nova Campinas Oftalmologia
Campinas, São Paulo, 13010-111
Universidade Federal de Goias
Goiânia, Goiás, 74180-010
Hospital Medicina dos Olhos
Osasco, São Paulo, 06010-130
Hospital de Olhos MS
Rio Verde, 79002-075
Escola Paulista de Medicina
São Paulo, 04023-062
Hospital das Clínicas - Faculdade de Medicina
São Paulo, 14049-900
Australia5 sites
Vision Eye Institute Chatswood
Chatsworth, New South Wales
Melbourne Eye Specialists
Fitzroy, Victoria 3065
Waverley Eye Clinic
Glen Waverley, Vctoria 3150
Marsden Eye Specialists, Parramatta
Paramatta, New South Wales
Preston Eye Clinic
Preston, Victoria 3072
Israel4 sites
Barzilai Medical Center
Ashkelon, 78278
Bnai Zion M.C.
Haifa, 31048
Rambam Medical Center
Haifa, 31096
Carmel Medical Center
Haifa, 34362
Hungary3 sites
Ganglion Medical Center
Pécs, H-7621
Markusovszky Korhaz
Szombathely, H-9700
Zala Megyei Kórház
Zalaegerszeg, H-8900
Philippines3 sites
Asian Eye Institute
Makati, 1200
Pacific Eyecare & Laser Institute
Makati, 1200
Makati Medical Center
Makati, 1229
Austria2 sites
University of Graz
Graz, A-8036
University of Vienna
Vienna, 1090
Belgium2 sites
University Hospitals Leuven
Leuven, B-3000
CHU Sart Tilman
Liège, 4000
Hong Kong2 sites
Hong Kong Eye Hospital
Hong Kong
The University of Hong Kong
Hong Kong
Taiwan2 sites
Buddhist Tzu Chi General Hospital (BTCGH)
Hualien City, Hualien, 970
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
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 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.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Bimatoprost SR, Active Comparator: Timolol 0.5%, Sham: Applicator Without Needle, 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
Also called AGN-192024
Bimatoprost SR administered in the study eye 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.
Sham: Applicator Without NeedleOther
Sham administered on Day 1, Week 16, and Week 32.
Timolol Vehicle (placebo)Drug
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost SR 15 μg | Experimental | 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. Receives: Drug: Bimatoprost SR; Drug: Active Comparator: Timolol 0.5%; Other: Sham: Applicator Without Needle; Drug: Timolol Vehicle (placebo) |
| Bimatoprost SR 10 μg | Experimental | 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. Receives: Drug: Bimatoprost SR; Drug: Active Comparator: Timolol 0.5%; Other: Sham: Applicator Without Needle; Drug: Timolol Vehicle (placebo) |
| Timolol 0.5% | Active comparator | 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. Receives: Drug: Active Comparator: Timolol 0.5%; Other: Sham: Applicator Without Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)
IOP in the Study Eye at Week 2 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Measured: Week 2 (Hour 0)
IOP in the Study Eye at Week 2 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Measured: Week 2 (Hour 2)
IOP in the Study Eye at Week 6 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Measured: Week 6 (Hour 0)
IOP in the Study Eye at Week 6 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Measured: Week 6 (Hour 2)
IOP in the Study Eye at Week 12 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Measured: Week 12 (Hour 0)
IOP in the Study Eye at Week 12 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Measured: Week 12 (Hour 2)
Secondary outcomes (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 (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.
- First posted25 Sep 2014 (estimated)
- Study start15 Dec 2014
- Primary completion19 Feb 2018
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina Bejanian, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247804
- Sponsor's protocol ID
- 192024-091
- Other IDs
- 2014-003037-26, 2014
- Status last verified
- May 2020
- First submitted
- 22 Sep 2014
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 36378864Medeiros 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02247804
- Acronym / sponsor ID
- 192024-091
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 594 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost SR 15 μg | Experimental | Drug: Bimatoprost SR, Drug: Active Comparator: Timolol 0.5%, Other: Sham: Applicator Without Needle, Drug: Timolol Vehicle (placebo)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. |
| Bimatoprost SR 10 μg | Experimental | Drug: Bimatoprost SR, Drug: Active Comparator: Timolol 0.5%, Other: Sham: Applicator Without Needle, Drug: Timolol Vehicle (placebo)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. |
| Timolol 0.5% | Active comparator | Drug: Active Comparator: Timolol 0.5%, Other: Sham: Applicator Without NeedleStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bimatoprost SRAlso: AGN-192024Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32. | Drug | Bimatoprost SR 10 μg, Bimatoprost SR 15 μg |
| Active Comparator: Timolol 0.5%Timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Drug | Bimatoprost SR 10 μg, Bimatoprost SR 15 μg, Timolol 0.5% |
| Sham: Applicator Without NeedleSham administered on Day 1, Week 16, and Week 32. | Other | Bimatoprost SR 10 μg, Bimatoprost SR 15 μg, Timolol 0.5% |
| Timolol Vehicle (placebo)Timolol vehicle administered once in the morning and once in the evening for up to 20 months. | Drug | Bimatoprost SR 10 μg, Bimatoprost SR 15 μg |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36378864Weinreb 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.
- Derived from this study: PubMed 35643967Medeiros 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Bejanian study director
Allergan
106 sites in 14 countries: see every site and its status.
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 106 sites in 14 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Poland, Spain, Brazil, Australia and 9 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 24 Apr 2020). 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 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)). 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 NCT02247804, which also lists 2 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 11 Jun 2020.