Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
NCT ID: NCT01157364
Last Updated: 2020-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
109 participants
INTERVENTIONAL
2010-09-23
2016-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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bimatoprost 20 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 20 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
bimatoprost 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 15 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 15 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 10 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 10 µg generation 2
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 6 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 6 µg generation 2
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 15 µg generation 1, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 15 µg generation 1
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
bimatoprost 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 10 µg generation 1, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 10 µg generation 1
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
bimatoprost 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Interventions
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bimatoprost 20 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
bimatoprost 15 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 10 µg generation 2
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 6 µg generation 2
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 15 µg generation 1
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
bimatoprost 10 µg generation 1
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
bimatoprost 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Anticipated wearing of contact lenses during the study
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Sall Research Medical Center
Artesia, California, United States
Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego
La Jolla, California, United States
Doheny Eye Institute
Los Angeles, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Shasta Eye Medical Group, Inc.
Redding, California, United States
Grutzmacher and Lewis, Inc.
Sacramento, California, United States
Pacific Eye Surgeons
San Luis Obispo, California, United States
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Specialty Eye Care
Parker, Colorado, United States
The Eye Associates of Manatee
Bradenton, Florida, United States
Emory University, The Emory Eye Center
Atlanta, Georgia, United States
Coastal Research Associates
Roswell, Georgia, United States
Springfield Clinic
Springfield, Illinois, United States
Glaucoma Consultants
Baltimore, Maryland, United States
Tufts Medical Center/New England Eye Center
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
ActivMed Practices & Research
Methuen, Massachusetts, United States
Clinical Eye Research of Boston/ Charles River Eye Associates
Winchester, Massachusetts, United States
Moyes Eye Center
Kansas City, Missouri, United States
Northern New Jersey Eye Institute PA
South Orange, New Jersey, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Glaucoma Associates of NY
New York, New York, United States
Rochester Ophthalmological Group PC
Rochester, New York, United States
Charlotte Eye Ear Nose & Throat Associates, PA
Charlotte, North Carolina, United States
Cornerstone Eye Care
High Point, North Carolina, United States
James D. Branch, MD
Winston-Salem, North Carolina, United States
Legacy Good Samaritan - Devers Eye Institute
Portland, Oregon, United States
Scott & Christie and Associates
Cranberry Township, Pennsylvania, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
Keystone Research LTD
Austin, Texas, United States
Glaucoma Associates of TX
Dallas, Texas, United States
R and R Eye Research
San Antonio, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Focus Clinical Research
Salt Lake City, Utah, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Melbourne Eye Specialists
Fitzroy, , Australia
Eye Associates
Sydney New South Wales, , Australia
UZ Leuven, Campus St. Rafael
Dienst Oogheelkunde, , Belgium
Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia
São Paulo, , Brazil
A.C. S. Crichton Prof. Corp
Calgary, Alberta, Canada
Eye Care Center
Halifax, Nova Scotia, Canada
Anjema Eye Institute
Chatham, Ontario, Canada
Galen Eye Centre
Kingston, Ontario, Canada
Ivey Eye Institute
London, Ontario, Canada
Institut de l'œil des Laurentides
Boisbriand, Quebec, Canada
Clarity Eye Institute
Vaughan, , Canada
Staedtisches Klinikum Department of Opthalmology
Karlsruhe, , Germany
Kaplan Medical Center
Rohovot, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Sam Rothberg Glaucoma Center,
Tel Litwinsky, , Israel
Asian Eye Institute
Makati City, , Philippines
Pacific Eye and Laser Institute (PELI)
Makati City, , Philippines
St. Lukes Medical Center-Quezon City
Metro Manila, , Philippines
Singapore National Eye Center
Singapore, , Singapore
Valles Oftalmologia Recerca, Hospital General de Catalunya,
Sant Cugat del Vallès, , Spain
Fundacion Oftalmologica Del Mediterraneo
Valencia, , Spain
Countries
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References
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Craven ER, Walters T, Christie WC, Day DG, Lewis RA, Goodkin ML, Chen M, Wangsadipura V, Robinson MR, Bejanian M; Bimatoprost SR Study Group. 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients. Drugs. 2020 Feb;80(2):167-179. doi: 10.1007/s40265-019-01248-0.
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.
Other Identifiers
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2011-005091-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
192024-041D
Identifier Type: -
Identifier Source: org_study_id
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