Clinical trial NCT01157364: Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
Official title: An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-07-07
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Uncontrolled medical conditions
* Anticipated wearing of contact lenses during the study

Primary outcomes:
measure: Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
timeFrame: Baseline, Month 24
Secondary outcomes:
measure: Time-Matched Intraocular Pressure (IOP) in the Study Eye
timeFrame: Baseline to Month 6
measure: Mean Diurnal IOP in the Study Eye
timeFrame: Baseline, Month 6
measure: Time to Rescue Treatment or Re-Treatment in the Study Eye
timeFrame: 24 Months
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: La Jolla
country: United States
facility: Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: Doheny Eye Institute
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Redding
country: United States
facility: Shasta Eye Medical Group, Inc.
state: California
city: Sacramento
country: United States
facility: Grutzmacher and Lewis, Inc.
state: California
city: San Luis Obispo
country: United States
facility: Pacific Eye Surgeons
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Parker
country: United States
facility: Specialty Eye Care
state: Colorado
city: Bradenton
country: United States
facility: The Eye Associates of Manatee
state: Florida
city: Atlanta
country: United States
facility: Emory University, The Emory Eye Center
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates
state: Georgia
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Baltimore
country: United States
facility: Glaucoma Consultants
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center/New England Eye Center
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
city: Winchester
country: United States
facility: Clinical Eye Research of Boston/ Charles River Eye Associates
state: Massachusetts
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute PA
state: New Jersey
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: New York
country: United States
facility: Glaucoma Associates of NY
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group PC
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates, PA
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Winston-Salem
country: United States
facility: James D. Branch, MD
state: North Carolina
city: Portland
country: United States
facility: Legacy Good Samaritan - Devers Eye Institute
state: Oregon
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Austin
country: United States
facility: Keystone Research LTD
state: Texas
city: Dallas
country: United States
facility: Glaucoma Associates of TX
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Salt Lake City
country: United States
facility: Focus Clinical Research
state: Utah
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Fitzroy
country: Australia
facility: Melbourne Eye Specialists
city: Sydney New South Wales
country: Australia
facility: Eye Associates
city: Dienst Oogheelkunde
country: Belgium
facility: UZ Leuven, Campus St. Rafael
city: Sao Paulo
country: Brazil
facility: Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia
city: Calgary
country: Canada
facility: A.C. S. Crichton Prof. Corp
state: Alberta
city: Halifax
country: Canada
facility: Eye Care Center
state: Nova Scotia
city: Chatham
country: Canada
facility: Anjema Eye Institute
state: Ontario
city: Kingston
country: Canada
facility: Galen Eye Centre
state: Ontario
city: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
city: Boisbriand
country: Canada
facility: Institut de l'œil des Laurentides
state: Quebec
city: Vaughan
country: Canada
facility: Clarity Eye Institute
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Department of Opthalmology
city: Rohovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel-Hashomer
country: Israel
facility: The Sam Rothberg Glaucoma Center,
city: Makati City
country: Philippines
facility: Asian Eye Institute
city: Makati City
country: Philippines
facility: Pacific Eye and Laser Institute (PELI)
city: Metro Manila
country: Philippines
facility: St. Lukes Medical Center-Quezon City
city: Singapore
country: Singapore
facility: Singapore National Eye Center
city: Sant Cugat
country: Spain
facility: Valles Oftalmologia Recerca, Hospital General de Catalunya,
city: Valencia
country: Spain
facility: Fundacion Oftalmologica Del Mediterraneo
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.