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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: bimatoprost 20 µg generation 2; Drug: bimatoprost 0.03%; Drug: bimatoprost 15 µg generation 2; Drug: bimatoprost 10 µg generation 2; Drug: bimatoprost 6 µg generation 2; Drug: bimatoprost 15 µg generation 1; Drug: bimatoprost 10 µg generation 1

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Fitzroy, Australia, 3065
    • Melbourne Eye Specialists
  • Sydney New South Wales, Australia, 2000
    • Eye Associates
• Belgium
  • Dienst Oogheelkunde, Belgium, Leuven 3000
    • UZ Leuven, Campus St. Rafael
• Brazil
  • Sao Paulo, Brazil, 04023-062
    • Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia
• Canada
  • Vaughan, Canada, L4K 0C5
    • Clarity eye Institute
  • Alberta
    • Calgary, Alberta, Canada, T3E-7M8
      • A.C. S. Crichton Prof. Corp
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Eye Care Center
  • Ontario
    • Chatham, Ontario, Canada, N7M 5J7
      • Anjema Eye Institute
    • Kingston, Ontario, Canada, K7K 6Z6
      • Galen Eye Centre
    • London, Ontario, Canada, N6A 4V2
      • Ivey Eye Institute
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 1S6
      • Institut De L'Oeil Des Laurentides
• Germany
  • Karlsruhe, Germany, 76133
    • Staedtisches Klinikum Department of Opthalmology
• Israel
  • Rohovot, Israel, 76100
    • Kaplan Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
  • Tel-Hashomer, Israel, 52621
    • The Sam Rothberg Glaucoma Center,
• Philippines
  • Makati City, Philippines, 1200
    • Asian Eye Institute
  • Makati City, Philippines, 1209
    • Pacific Eye and Laser Institute (PELI)
  • Metro Manila, Philippines, Quezon City 1112
    • St. Lukes Medical Center-Quezon City
• Singapore
  • Singapore, Singapore, 168751
    • Singapore National Eye Center
• Spain
  • Sant Cugat, Spain, 08195
    • Valles Oftalmologia Recerca, Hospital General de Catalunya,
  • Valencia, Spain, 46015
    • Fundación Oftalmológica del Mediterráneo
• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • La Jolla, California, United States, 92093
      • Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego
    • Los Angeles, California, United States, 90033
      • Doheny Eye Institute
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
    • Redding, California, United States, 96002
      • Shasta Eye Medical Group, Inc.
    • Sacramento, California, United States, 95815
      • Grutzmacher and Lewis, Inc.
    • San Luis Obispo, California, United States, 93401
      • Pacific Eye Surgeons
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
  • Colorado
    • Parker, Colorado, United States, 80134
      • Specialty Eye Care
  • Florida
    • Bradenton, Florida, United States, 34209
      • The Eye Associates of Manatee
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University, The Emory Eye Center
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates
  • Illinois
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Glaucoma Consultants
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center/New England Eye Center
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research
    • Winchester, Massachusetts, United States, 01890
      • Clinical Eye Research of Boston/ Charles River Eye Associates
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Moyes Eye Center
  • New Jersey
    • South Orange, New Jersey, United States, 07079
      • Northern New Jersey Eye Institute PA
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • New York, New York, United States, 10003
      • Glaucoma Associates of NY
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose & Throat Associates, PA
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care
    • Winston-Salem, North Carolina, United States, 27101
      • James D. Branch, MD
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan - Devers Eye Institute
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates
    • Philadelphia, Pennsylvania, United States, 19148
      • Philadelphia Eye Associates
  • Texas
    • Austin, Texas, United States, 78731
      • Keystone Research LTD
    • Dallas, Texas, United States, 75231
      • Glaucoma Associates of TX
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Focus Clinical Research
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of open angle glaucoma or ocular hypertension

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: bimatoprost 20 µg generation 2; Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.; Drug: 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 Names: LUMIGAN®
Other: 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.	Drug: 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 Names: LUMIGAN®; Drug: 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).
Other: 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.	Drug: 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 Names: LUMIGAN®; Drug: 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).
Other: 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.	Drug: 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 Names: LUMIGAN®; Drug: 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).
Other: 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.	Drug: 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 Names: LUMIGAN®; Drug: bimatoprost 15 µg generation 1; Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
Other: 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.	Drug: 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 Names: LUMIGAN®; Drug: bimatoprost 10 µg generation 1; Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-Matched Intraocular Pressure (IOP) in the Study Eye	IOP is a measurement of the fluid pressure inside the study eye.	Baseline to Month 6
Mean Diurnal IOP in the Study Eye	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.	Baseline, Month 6
Time to Rescue Treatment or Re-Treatment in the Study Eye	Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.	24 Months

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2010
• Primary Completion (Actual): July 27, 2016
• Study Completion (Actual): August 9, 2016

Study Registration Dates

• First Submitted: July 2, 2010
• First Submitted That Met QC Criteria: July 6, 2010
• First Posted (Estimate): July 7, 2010

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: 192024-041D; 2011-005091-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No