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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250651
• Other study ID #: 192024-092
• Secondary ID: 2014-003186-24
• Status: Completed
• Phase: Phase 3
• Start date: December 15, 2014
• Est. completion date: July 22, 2020

Study information

• Verified date: June 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: July 22, 2020
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous enrollment in another Allergan Bimatoprost SR Study

• Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye

• Anticipated need for laser eye surgery within the first 52 weeks of the study duration

• History of glaucoma surgery

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

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

Other:
• Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.

Drug:
• Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
• Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires - Hospital	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Instituto Oftalmologico de Buenos Aires Oftalmos	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Organización Médica de Investigación	Ciudad Autónoma de BuenosAires
Argentina	Clinica Privada de Ojos	Mar del Plata	Buenos Aires
Argentina	Oftar Centro Privado de Oftalmologia	Mendoza
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Argentina	Centro Médico Grupo Laser Visión	Rosario	Santa Fe
Argentina	Centro Medico Oftalmologia Global	Rosario	Santa Fe
Canada	Trimed Eye Center	Barrie	Ontario
Canada	Institut De L'Oeil Des Laurentides	Boisbriand	Quebec
Canada	ACS Crichton Prof. Corp	Calgary	Alberta
Canada	Uptown Eye Specialists	Concord	Ontario
Canada	Clinique d' ophtalmologie Dr Saurel	Drummondville	Quebec
Canada	Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences	Halifax	Nova Scotia
Canada	Galen Eye Centre	Kingston	Ontario
Canada	Ophthalmic Consultant Centres Inc	Mississauga	Ontario
Canada	Bellevue Clinic	Montreal	Quebec
Canada	GOGiunta Ophtalmologie	Sherbrooke	Quebec
Canada	Sunnybrook Research Institute	Toronto	Ontario
Colombia	Fundación Oftalmologica Nacional Fundonal	Bogota	Distrito Capital De Bogota
Colombia	Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A.	Cali
Colombia	Fundacion Oftalmologica de Santander Foscal	Floridablanca	Santander
Colombia	Clinica de Oftalmologia Sandiego S.A.	Medellin	Antioquia
Czechia	Ocni klinika	Brno	Jihlavska
Czechia	Nemocnicni Lekarna	Hradec Kralove	Sokolska
Czechia	Ocni klinika Pardubice	Prague
Egypt	Ain Shams University Hospital	Cairo
Egypt	Al Kasr Al Ainy Cairo University Hospital	Cairo
Egypt	Menoufia University Hospital	Shibin al-Kawm	Cairo
Germany	Augen Zentrum Nordwest	Ahaus	Nordrhein-Westfalen
Germany	Universitätsklinik Magdeburg	Magdeburg	Sachsen-Anhalt
Germany	Klinisches Studienzentrum	Mainz
Germany	Augenärzte am St. Franziskus-Hospital	Munster	Nordrhein-Westfalen
Germany	Klinikum der Universität Regensburg	Regensburg	Bayern
Italy	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele	Catania	Sicilia
Italy	Università degli Studi G. D'Annunzio Chieti-Pescara	Chieti	Abruzzo
Italy	Azienda Ospedaliera-Polo Universitario San Paolo	Milano	Lombardia
Italy	Unità Operativa di Oculistica Ospedale San Raffaele S.r.l.	Milano
Italy	Ospedale Santa Maria Della Misericordia	Perugia
Italy	Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa	Pisa	Toscana
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Malaysia	Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology	Cheras	Kuala Lumpur
New Zealand	Capital Eye Specialists	Wellington
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore National Eye Centre	Singapore
South Africa	Pretoria Eye Institute	Arcadia	Pretoria
South Africa	Horizon Eye Care Centre	Bloemfontein	Free State
Turkey	Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali	Manisa
Turkey	Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali	Meselik	Eskisehir
Turkey	Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari	Pendik	Istanbul
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Queen Alexandra Hospital	Cosham
United Kingdom	Princess Alexandra Eye Pavilion	Edinburgh
United Kingdom	James Paget University Hosp NHS Foundation Trust	Great Yarmouth
United Kingdom	Aintree University Hospital NHS Foundation Trust	Liverpool
United Kingdom	St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust	Liverpool
United Kingdom	ICORG	London
United Kingdom	In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital	London
United Kingdom	Peterborough City Hospital Research and Development Department	Peterborough
United States	Eye Associates of New Mexico	Albuquerque	New Mexico
United States	Lehigh Valley Eye Center, P.C.	Allentown	Pennsylvania
United States	Emory University Eye Center	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Johns Hopkins School of Medicine, Wilmer Eye Institute	Baltimore	Maryland
United States	Specialty Eyecare Centre	Bellevue	Washington
United States	Argus Research at Cape Coral Eye Center	Cape Coral	Florida
United States	Arizona Eye Center	Chandler	Arizona
United States	Charlotte Eye Ear Nose & Throat Associates, PA	Charlotte	North Carolina
United States	Specialty Retinal Center	Coral Springs	Florida
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Danbury Eye Physicians and Surgeons PC	Danbury	Connecticut
United States	Bruce A Segal, M.D.	Delray Beach	Florida
United States	Eye Center South	Dothan	Alabama
United States	Bergstrom Eye and Laser Clinic	Fargo	North Dakota
United States	Vold Vision	Fayetteville	Arkansas
United States	Eye Associates of Fort Myers	Fort Myers	Florida
United States	Eye Clinic at Shands Medical Plaza	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	Mark B. Kislinger, MD, Inc.	Glendora	California
United States	Inland Eye Specialists	Hemet	California
United States	Alkek Eye Center	Houston	Texas
United States	Southern California Eye Physicians and Surgeons	Los Alamitos	California
United States	Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex	Louisville	Kentucky
United States	DCT-Shah Research, LLC dba Discovery ClinicalTrials	Mission	Texas
United States	Mount Sinai School of Medicine	New York	New York
United States	Rutgers-New Jersey Medical School	Newark	New Jersey
United States	Eye Research Foundation	Newport Beach	California
United States	Bascom Palmer Eye Institute, University of Miami	Palm Beach Gardens	Florida
United States	Insight Vision Group	Parker	Colorado
United States	North Bay Eye Associates, Inc.	Petaluma	California
United States	Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania	Philadelphia	Pennsylvania
United States	Key Whitman Eye Center	Plano	Texas
United States	Legacy Good Samaritan Hospital - Devers Eye Institute	Portland	Oregon
United States	Alterman, Modi & Wolter	Poughkeepsie	New York
United States	The Eye Centers of Racine and Kenosha	Racine	Wisconsin
United States	Shasta Eye Medical Group, Inc.	Redding	California
United States	Vistar Eye Center	Roanoke	Virginia
United States	Virdi Eye Clinic	Rock Island	Illinois
United States	Tekwani Vision Center	Saint Louis	Missouri
United States	University of California (UCSF) Department of Ophthalmology	San Francisco	California
United States	Pacific Eye Surgeons	San Luis Obispo	California
United States	Shepard Eye Center	Santa Maria	California
United States	Center for Sight	Sarasota	Florida
United States	MedEye Associates	South Miami	Florida
United States	East West Eye Institute	Torrance	California
United States	Wolstan & Goldberg Eye Associates	Torrance	California
United States	South Shore Eye Care, LLP	Wantagh	New York
United States	Wenatchee valley Hospital & Clinics, Clinical research department	Wenatchee	Washington
United States	Clinical Eye Research of Boston, Co.	Winchester	Massachusetts
United States	James D. Branch, MD	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Colombia,  Czechia,  Egypt,  Germany,  Italy,  Korea, Republic of,  Malaysia,  New Zealand,  Singapore,  South Africa,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)
Primary	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.	Week 2 (Hour 0)
Primary	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.	Week 2 (Hour 2)
Primary	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.	Week 6 (Hour 0)
Primary	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.	Week 6 (Hour 2)
Primary	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.	Week 12 (Hour 0)
Primary	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.	Week 12 (Hour 2)
Secondary	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.	Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)

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