Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension

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

Sponsors

Lead Sponsor: Allergan

Source Allergan
Brief 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.

Overall Status Completed
Start Date December 15, 2014
Completion Date July 19, 2019
Primary Completion Date February 19, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)
IOP in the Study Eye at Week 2 (Hour 0) Week 2 (Hour 0)
IOP in the Study Eye at Week 2 (Hour 2) Week 2 (Hour 2)
IOP in the Study Eye at Week 6 (Hour 0) Week 6 (Hour 0)
IOP in the Study Eye at Week 6 (Hour 2) Week 6 (Hour 2)
IOP in the Study Eye at Week 12 (Hour 0) Week 12 (Hour 0)
IOP in the Study Eye at Week 12 (Hour 2) Week 12 (Hour 2)
Secondary Outcome
Measure Time Frame
Change From Baseline in IOP in the Study Eye Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)
Enrollment 594
Condition
Intervention

Intervention Type: Drug

Intervention Name: Bimatoprost SR

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

Other Name: AGN-192024

Intervention Type: Drug

Intervention Name: Active Comparator: Timolol 0.5%

Description: Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Intervention Type: Other

Intervention Name: Sham: Applicator Without Needle

Description: Sham administered on Day 1, Week 16, and Week 32.

Intervention Type: Drug

Intervention Name: Timolol Vehicle (placebo)

Description: Timolol vehicle administered once in the morning and once in the evening for up to 20 months.

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Marina Bejanian Study Director Allergan
Location
Facility:
Arizona Glaucoma Specialists | Phoenix, Arizona, 85050, United States
Lugene Eye Institute | Glendale, California, 91205, United States
Lakeside Vision Center | Irvine, California, 92604, United States
Hamilton Glaucoma Center, Shiley Eye Center UCSD | La Jolla, California, 92037, United States
Atlantis Eye Care | Long Beach, California, 90808, United States
Glaucoma Institute of Beverly Hills | Los Angeles, California, 90048, United States
Montebello Medical Eye Center Inc. | Montebello, California, 90640, United States
Stanford University | Palo Alto, California, 94303, United States
Foothill Eye Institute | Pasadena, California, 91107, United States
Martel Eye Medical Group | Rancho Cordova, California, 95670, United States
Grutzmacher, Lewis and Sierra, Inc. | Sacramento, California, 95815, United States
Pacific Eye Associates | San Francisco, California, 94115, United States
Eye Associates of Colorado Springs | Colorado Springs, Colorado, 80907, United States
Palm Beach Eye Center, INC | Atlantis, Florida, 33461, United States
Nature Coast Clinical Research | Crystal River, Florida, 34429, United States
Levenson Eye Associates | Jacksonville, Florida, 32204, United States
East Florida Eye Institute | Stuart, Florida, 34994, United States
International Research Center | Tampa, Florida, 33603, United States
Coastal Research Associates, LLC | Roswell, Georgia, 30076, United States
Chicago Eye Specialists | Chicago, Illinois, 60619, United States
Indiana University School of Medicine | Indianapolis, Indiana, 46202, United States
Heart of America Eye Care PA | Shawnee Mission, Kansas, 66204, United States
Tulane Medical Center | New Orleans, Louisiana, 70112, United States
Eye Doctors of Washington | Chevy Chase, Maryland, 20815, United States
MedRACS, LLC | Quincy, Massachusetts, 02169, United States
Ocular Immunology and Uveitis Foundation | Waltham, Massachusetts, 02451, United States
University of Michigan | Ann Arbor, Michigan, 48109, United States
Minnesota Eye Constultants, P.A. | Bloomington, Minnesota, 55431, United States
Lifelong Vision Foundation | Chesterfield, Missouri, 63017, United States
Moyes Eye Center, PC | Kansas City, Missouri, 64154, United States
Northern New Jersey Eye Institute P.A. | South Orange, New Jersey, 07079, United States
Eyecare Ophthalmology Associates, PC | Bethpage, New York, 11714, United States
Montefiore Medical Center | Bronx, New York, 10467, United States
New York Eye and Ear Infirmary of Mount Sinai | New York, New York, 10003, United States
Rochester Ophthalmological Group PC | Rochester, New York, 14618, United States
2000 North Village Avenue | Rockville Centre, New York, 11570, United States
Glaucoma Consultants of the Capital Region | Slingerlands, New York, 12159, United States
8 Medical Park Drive | Asheville, North Carolina, 28803, United States
Albemarle Clinical Trials, LLC | Elizabeth City, North Carolina, 27909, United States
University Hospitals of Cleveland | Cleveland, Ohio, 44106, United States
The Ohio State University Havener Eye Institute | Columbus, Ohio, 43212, United States
Drs Fine Hoffman & Sims, LLC | Eugene, Oregon, 97401, United States
Wills Eye Institute - Glaucoma Research Center | Philadelphia, Pennsylvania, 19107, United States
Associates in Ophthalmology | Pittsburgh, Pennsylvania, 15219, United States
Carolinas Centers for Sight PC | Florence, South Carolina, 29501, United States
VRF Eye Specialty Group | Memphis, Tennessee, 38120, United States
Nashville Vision Associates | Nashville, Tennessee, 37205, United States
Keystone Research, LTD | Austin, Texas, 78731, United States
Glaucoma Associates of Texas | Dallas, Texas, 75231, United States
The Cataract, Glaucoma & Refractive Surgery Center | El Paso, Texas, 79902, United States
Houston Eye Associates | Houston, Texas, 77025, United States
Focal Point Vision | San Antonio, Texas, 78229, United States
R and R Eye Research, LLC | San Antonio, Texas, 78234, United States
Medical Center Ophthalmology Associates | San Antonio, Texas, 78240, United States
Piedmont Eye Center | Lynchburg, Virginia, 24502, United States
West Virginia University | Morgantown, West Virginia, 26506, United States
Vision Eye Institute Chatswood | Chatsworth, New South Wales, Australia
Melbourne Eye Specialists | Fitzroy, Victoria 3065, Australia
Waverley Eye Clinic | Glen Waverley, Vctoria 3150, Australia
Marsden Eye Specialists, Parramatta | Paramatta, New South Wales, Australia
Preston Eye Clinic | Preston, Victoria 3072, Australia
University of Graz | Graz, A-8036, Austria
University of Vienna | Vienna, 1090, Austria
University Hospitals Leuven | Leuven, B-3000, Belgium
CHU Sart Tilman | Liege, 4000, Belgium
Universidade Federal de Goias | Goiania, Goias, 74180-010, Brazil
Elo Oftalmologistas Associados | Belo Horizonte, Minas Gerais, 30140-090, Brazil
Nova Campinas Oftalmologia | Campinas, Sao Paulo, 13010-111, Brazil
Hospital Medicina dos Olhos | Osasco, Sao Paulo, 06010-130, Brazil
Hospital de Olhos MS | Rio Verde, 79002-075, Brazil
Escola Paulista de Medicina | Sao Paulo, 04023-062, Brazil
Hospital das Clínicas - Faculdade de Medicina | Sao Paulo, 14049-900, Brazil
Glostrup Hospital | Glostrup, 2600, Denmark
Hong Kong Eye Hospital | Hong Kong, Hong Kong
The University of Hong Kong | Hong Kong, Hong Kong
Ganglion Medical Center | Pecs, H-7621, Hungary
Markusovszky Korhaz | Szombathely, H-9700, Hungary
Zala Megyei Kórház | Zalaegerszeg, H-8900, Hungary
Barzilai Medical Center | Ashkelon, 78278, Israel
Bnai Zion M.C. | Haifa, 31048, Israel
Rambam Medical Center | Haifa, 31096, Israel
Carmel Medical Center | Haifa, 34362, Israel
Centro Oftalmológico Mácula Diagnóstico y Tratamiento | Lima, Lima 27, Peru
Asian Eye Institute | Makati, 1200, Philippines
Pacific Eyecare & Laser Institute | Makati, 1200, Philippines
Makati Medical Center | Makati, 1229, Philippines
Prywatna Klinika Okulistyczna OFTALMIKA | Bydgoszcz, 85-631, Poland
Optimum Profesorskie Centrum Okulistyki | Gdansk, 80-211, Poland
Public Clinical Hospital No. 1 | Lublin, 20-079, Poland
ZOZ OKO- TEST Poradnia Okulistyczna | Nowy Targ, 34-400, Poland
Diagnostic and Microsurgery Center of the Eye LENS | Olsztyn, 10-424, Poland
Retina Sp. z o.o | Warsaw, 01-364, Poland
Klinika Okulistyki WIML | Warsaw, 01-755, Poland
Uniwersytecki Szpital Kliniczny | Warszawa, 01-755, Poland
Uniwersyteck Szpital Kliniczny | Wroclaw, 50-368, Poland
Institut Clinic d'Oftalmologia | Barcelona, 08006, Spain
Institut Catala de la Retina | Barcelona, 08017, Spain
Hospital General de Catalunya | Barcelona, 08195, Spain
Hospital Universitario Reina Sofía | Cordoba, 14004, Spain
Hospital Clinico San Carlos | Madrid, 28004, Spain
Hospital Universitario Virgen Macarena | Sevilla, 41071, Spain
Hospital General | Valencia, 46017, Spain
Hospital Universitario Rio Hortega | Valladolid, 47012, Spain
Hospital Universitario Miguel Servet | Zaragoza, 50009, Spain
Buddhist Tzu Chi General Hospital (BTCGH) | Hualien, 970, Taiwan
Kaohsiung Veterans General Hospital | Kaohsiung, 81362, Taiwan
Location Countries

Australia

Austria

Belgium

Brazil

Denmark

Hong Kong

Hungary

Israel

Peru

Philippines

Poland

Spain

Taiwan

United States

Verification Date

May 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Bimatoprost SR 15 μg

Type: Experimental

Description: Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Label: Bimatoprost SR 10 μg

Type: Experimental

Description: Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Label: Timolol 0.5%

Type: Active Comparator

Description: Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov