Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants 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: NCT02247804
• Other study ID #: 192024-091
• Secondary ID: 2014-003037-26
• Status: Completed
• Phase: Phase 3
• Start date: December 15, 2014
• Est. completion date: July 19, 2019

Study information

• Verified date: May 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 594
• Est. completion date: July 19, 2019
• Est. primary completion date: February 19, 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 in either eye 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.
• 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.

Locations

Country	Name	City	State
Australia	Vision Eye Institute Chatswood	Chatsworth
Australia	Melbourne Eye Specialists	Fitzroy
Australia	Waverley Eye Clinic	Glen Waverley
Australia	Marsden Eye Specialists, Parramatta	Paramatta
Australia	Preston Eye Clinic	Preston
Austria	University of Graz	Graz
Austria	University of Vienna	Vienna
Belgium	University Hospitals Leuven	Leuven
Belgium	CHU Sart Tilman	Liege
Brazil	Elo Oftalmologistas Associados	Belo Horizonte	Minas Gerais
Brazil	Nova Campinas Oftalmologia	Campinas	Sao Paulo
Brazil	Universidade Federal de Goias	Goiania	Goias
Brazil	Hospital Medicina dos Olhos	Osasco	Sao Paulo
Brazil	Hospital de Olhos MS	Rio Verde
Brazil	Escola Paulista de Medicina	Sao Paulo
Brazil	Hospital das Clínicas - Faculdade de Medicina	Sao Paulo
Denmark	Glostrup Hospital	Glostrup
Hong Kong	Hong Kong Eye Hospital	Hong Kong
Hong Kong	The University of Hong Kong	Hong Kong
Hungary	Ganglion Medical Center	Pecs
Hungary	Markusovszky Korhaz	Szombathely
Hungary	Zala Megyei Kórház	Zalaegerszeg
Israel	Barzilai Medical Center	Ashkelon
Israel	Bnai Zion M.C.	Haifa
Israel	Carmel Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Peru	Centro Oftalmológico Mácula Diagnóstico y Tratamiento	Lima
Philippines	Asian Eye Institute	Makati
Philippines	Makati Medical Center	Makati
Philippines	Pacific Eyecare & Laser Institute	Makati
Poland	Prywatna Klinika Okulistyczna OFTALMIKA	Bydgoszcz
Poland	Optimum Profesorskie Centrum Okulistyki	Gdansk
Poland	Public Clinical Hospital No. 1	Lublin
Poland	ZOZ OKO- TEST Poradnia Okulistyczna	Nowy Targ
Poland	Diagnostic and Microsurgery Center of the Eye LENS	Olsztyn
Poland	Klinika Okulistyki WIML	Warsaw
Poland	Retina Sp. z o.o	Warsaw
Poland	Uniwersytecki Szpital Kliniczny	Warszawa
Poland	Uniwersyteck Szpital Kliniczny	Wroclaw
Spain	Hospital General de Catalunya	Barcelona
Spain	Institut Catala de la Retina	Barcelona
Spain	Institut Clinic d'Oftalmologia	Barcelona
Spain	Hospital Universitario Reina Sofía	Cordoba
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital General	Valencia
Spain	Hospital Universitario Rio Hortega	Valladolid
Spain	Hospital Universitario Miguel Servet	Zaragoza
Taiwan	Buddhist Tzu Chi General Hospital (BTCGH)	Hualien
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
United States	University of Michigan	Ann Arbor	Michigan
United States	8 Medical Park Drive	Asheville	North Carolina
United States	Palm Beach Eye Center, INC	Atlantis	Florida
United States	Keystone Research, LTD	Austin	Texas
United States	Eyecare Ophthalmology Associates, PC	Bethpage	New York
United States	Minnesota Eye Constultants, P.A.	Bloomington	Minnesota
United States	Montefiore Medical Center	Bronx	New York
United States	Lifelong Vision Foundation	Chesterfield	Missouri
United States	Eye Doctors of Washington	Chevy Chase	Maryland
United States	Chicago Eye Specialists	Chicago	Illinois
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Eye Associates of Colorado Springs	Colorado Springs	Colorado
United States	The Ohio State University Havener Eye Institute	Columbus	Ohio
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	The Cataract, Glaucoma & Refractive Surgery Center	El Paso	Texas
United States	Albemarle Clinical Trials, LLC	Elizabeth City	North Carolina
United States	Drs Fine Hoffman & Sims, LLC	Eugene	Oregon
United States	Carolinas Centers for Sight PC	Florence	South Carolina
United States	Lugene Eye Institute	Glendale	California
United States	Houston Eye Associates	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Lakeside Vision Center	Irvine	California
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Moyes Eye Center, PC	Kansas City	Missouri
United States	Hamilton Glaucoma Center, Shiley Eye Center UCSD	La Jolla	California
United States	Atlantis Eye Care	Long Beach	California
United States	Glaucoma Institute of Beverly Hills	Los Angeles	California
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	VRF Eye Specialty Group	Memphis	Tennessee
United States	Montebello Medical Eye Center Inc.	Montebello	California
United States	West Virginia University	Morgantown	West Virginia
United States	Nashville Vision Associates	Nashville	Tennessee
United States	Tulane Medical Center	New Orleans	Louisiana
United States	New York Eye and Ear Infirmary of Mount Sinai	New York	New York
United States	Stanford University	Palo Alto	California
United States	Foothill Eye Institute	Pasadena	California
United States	Wills Eye Institute - Glaucoma Research Center	Philadelphia	Pennsylvania
United States	Arizona Glaucoma Specialists	Phoenix	Arizona
United States	Associates in Ophthalmology	Pittsburgh	Pennsylvania
United States	MedRACS, LLC	Quincy	Massachusetts
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Rochester Ophthalmological Group PC	Rochester	New York
United States	2000 North Village Avenue	Rockville Centre	New York
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Grutzmacher, Lewis and Sierra, Inc.	Sacramento	California
United States	Focal Point Vision	San Antonio	Texas
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	R and R Eye Research, LLC	San Antonio	Texas
United States	Pacific Eye Associates	San Francisco	California
United States	Heart of America Eye Care PA	Shawnee Mission	Kansas
United States	Glaucoma Consultants of the Capital Region	Slingerlands	New York
United States	Northern New Jersey Eye Institute P.A.	South Orange	New Jersey
United States	East Florida Eye Institute	Stuart	Florida
United States	International Research Center	Tampa	Florida
United States	Ocular Immunology and Uveitis Foundation	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Denmark,  Hong Kong,  Hungary,  Israel,  Peru,  Philippines,  Poland,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (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 (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)

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