Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
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
2 other identifiers
interventional
109
10 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2010
Longer than P75 for phase_1
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2010
CompletedFirst Posted
Study publicly available on registry
July 7, 2010
CompletedStudy Start
First participant enrolled
September 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2016
CompletedResults Posted
Study results publicly available
March 30, 2020
CompletedMarch 30, 2020
March 1, 2020
5.8 years
July 2, 2010
January 10, 2020
March 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Baseline, Month 24
Secondary Outcomes (3)
Time-Matched Intraocular Pressure (IOP) in the Study Eye
Baseline to Month 6
Mean Diurnal IOP in the Study Eye
Baseline, Month 6
Time to Rescue Treatment or Re-Treatment in the Study Eye
24 Months
Study Arms (6)
bimatoprost 20 µg generation 2, bimatoprost 0.03%
OTHERSingle 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 15 µg generation 2, bimatoprost 0.03%
OTHERSingle 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 10 µg generation 2, bimatoprost 0.03%
OTHERSingle 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 6 µg generation 2, bimatoprost 0.03%
OTHERSingle 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 15 µg generation 1, bimatoprost 0.03%
OTHERSingle 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 10 µg generation 1, bimatoprost 0.03%
OTHERSingle 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.
Interventions
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
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).
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).
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).
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of open angle glaucoma or ocular hypertension
You may not qualify if:
- Uncontrolled medical conditions
- Anticipated wearing of contact lenses during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (57)
Sall Research Medical Center
Artesia, California, 90701, United States
Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego
La Jolla, California, 92093, United States
Doheny Eye Institute
Los Angeles, California, 90033, United States
Martel Eye Medical Group
Rancho Cordova, California, 95670, United States
Shasta Eye Medical Group, Inc.
Redding, California, 96002, United States
Grutzmacher and Lewis, Inc.
Sacramento, California, 95815, United States
Pacific Eye Surgeons
San Luis Obispo, California, 93401, United States
Wolstan & Goldberg Eye Associates
Torrance, California, 90505, United States
Specialty Eye Care
Parker, Colorado, 80134, United States
The Eye Associates of Manatee
Bradenton, Florida, 34209, United States
Emory University, The Emory Eye Center
Atlanta, Georgia, 30322, United States
Coastal Research Associates
Roswell, Georgia, 30076, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Glaucoma Consultants
Baltimore, Maryland, 21204, United States
Tufts Medical Center/New England Eye Center
Boston, Massachusetts, 02111, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
ActivMed Practices & Research
Methuen, Massachusetts, 01844, United States
Clinical Eye Research of Boston/ Charles River Eye Associates
Winchester, Massachusetts, 01890, United States
Moyes Eye Center
Kansas City, Missouri, 64154, United States
Northern New Jersey Eye Institute PA
South Orange, New Jersey, 07079, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
Glaucoma Associates of NY
New York, New York, 10003, United States
Rochester Ophthalmological Group PC
Rochester, New York, 14618, United States
Charlotte Eye Ear Nose & Throat Associates, PA
Charlotte, North Carolina, 28210, United States
Cornerstone Eye Care
High Point, North Carolina, 27262, United States
James D. Branch, MD
Winston-Salem, North Carolina, 27101, United States
Legacy Good Samaritan - Devers Eye Institute
Portland, Oregon, 97210, United States
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148, United States
Keystone Research LTD
Austin, Texas, 78731, United States
Glaucoma Associates of TX
Dallas, Texas, 75231, United States
R and R Eye Research
San Antonio, Texas, 78229, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Focus Clinical Research
Salt Lake City, Utah, 84107, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Melbourne Eye Specialists
Fitzroy, 3065, Australia
Eye Associates
Sydney New South Wales, 2000, Australia
UZ Leuven, Campus St. Rafael
Dienst Oogheelkunde, Leuven 3000, Belgium
Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia
São Paulo, 04023-062, Brazil
A.C. S. Crichton Prof. Corp
Calgary, Alberta, T3E-7M8, Canada
Eye Care Center
Halifax, Nova Scotia, B3H 2Y9, Canada
Anjema Eye Institute
Chatham, Ontario, N7M 5J7, Canada
Galen Eye Centre
Kingston, Ontario, K7K 6Z6, Canada
Ivey Eye Institute
London, Ontario, N6A 4V2, Canada
Institut de l'œil des Laurentides
Boisbriand, Quebec, J7H 1S6, Canada
Clarity Eye Institute
Vaughan, L4K 0C5, Canada
Staedtisches Klinikum Department of Opthalmology
Karlsruhe, 76133, Germany
Kaplan Medical Center
Rohovot, 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
The Sam Rothberg Glaucoma Center,
Tel Litwinsky, 52621, Israel
Asian Eye Institute
Makati City, 1200, Philippines
Pacific Eye and Laser Institute (PELI)
Makati City, 1209, Philippines
St. Lukes Medical Center-Quezon City
Metro Manila, Quezon City 1112, Philippines
Singapore National Eye Center
Singapore, 168751, Singapore
Valles Oftalmologia Recerca, Hospital General de Catalunya,
Sant Cugat del Vallès, 08195, Spain
Fundacion Oftalmologica Del Mediterraneo
Valencia, 46015, Spain
Related Publications (2)
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.
PMID: 31884564BACKGROUNDMedeiros 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.
PMID: 35643967DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2010
First Posted
July 7, 2010
Study Start
September 23, 2010
Primary Completion
July 27, 2016
Study Completion
August 9, 2016
Last Updated
March 30, 2020
Results First Posted
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share