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Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
bimatoprost 20 µg generation 2
bimatoprost 15 µg generation 2
bimatoprost 10 µg generation 2
bimatoprost 6 µg generation 2
bimatoprost 15 µg generation 1
bimatoprost 10 µg generation 1
bimatoprost 0.03%
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of open angle glaucoma or ocular hypertension

Exclusion Criteria:

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

Sites / Locations

  • Sall Research Medical Center
  • Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego
  • Doheny Eye Institute
  • Martel Eye Medical Group
  • Shasta Eye Medical Group, Inc.
  • Grutzmacher and Lewis, Inc.
  • Pacific Eye Surgeons
  • Wolstan & Goldberg Eye Associates
  • Specialty Eye Care
  • The Eye Associates of Manatee
  • Emory University, The Emory Eye Center
  • Coastal Research Associates
  • Springfield Clinic
  • Glaucoma Consultants
  • Tufts Medical Center/New England Eye Center
  • Ophthalmic Consultants of Boston
  • ActivMed Practices & Research
  • Clinical Eye Research of Boston/ Charles River Eye Associates
  • Moyes Eye Center
  • Northern New Jersey Eye Institute PA
  • Ophthalmic Consultants of Long Island
  • Glaucoma Associates of NY
  • Rochester Ophthalmological Group PC
  • Charlotte Eye Ear Nose & Throat Associates, PA
  • Cornerstone Eye Care
  • James D. Branch, MD
  • Legacy Good Samaritan - Devers Eye Institute
  • Scott & Christie and Associates
  • Philadelphia Eye Associates
  • Keystone Research LTD
  • Glaucoma Associates of TX
  • R and R Eye Research
  • Medical Center Ophthalmology Associates
  • Focus Clinical Research
  • Spokane Eye Clinical Research
  • Wenatchee Valley Medical Center
  • Melbourne Eye Specialists
  • Eye Associates
  • UZ Leuven, Campus St. Rafael
  • Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia
  • A.C. S. Crichton Prof. Corp
  • Eye Care Center
  • Anjema Eye Institute
  • Galen Eye Centre
  • Ivey Eye Institute
  • Institut de l'œil des Laurentides
  • Clarity Eye Institute
  • Staedtisches Klinikum Department of Opthalmology
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • The Sam Rothberg Glaucoma Center,
  • Asian Eye Institute
  • Pacific Eye and Laser Institute (PELI)
  • St. Lukes Medical Center-Quezon City
  • Singapore National Eye Center
  • Valles Oftalmologia Recerca, Hospital General de Catalunya,
  • Fundacion Oftalmologica Del Mediterraneo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

bimatoprost 20 µg generation 2, bimatoprost 0.03%

bimatoprost 15 µg generation 2, bimatoprost 0.03%

bimatoprost 10 µg generation 2, bimatoprost 0.03%

bimatoprost 6 µg generation 2, bimatoprost 0.03%

bimatoprost 15 µg generation 1, bimatoprost 0.03%

bimatoprost 10 µg generation 1, bimatoprost 0.03%

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time-Matched Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye.
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.
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.

Full Information

First Posted
July 2, 2010
Last Updated
March 27, 2020
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01157364
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 23, 2010 (Actual)
Primary Completion Date
July 27, 2016 (Actual)
Study Completion Date
August 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bimatoprost 20 µg generation 2, bimatoprost 0.03%
Arm Type
Other
Arm Description
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.
Arm Title
bimatoprost 15 µg generation 2, bimatoprost 0.03%
Arm Type
Other
Arm Description
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.
Arm Title
bimatoprost 10 µg generation 2, bimatoprost 0.03%
Arm Type
Other
Arm Description
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.
Arm Title
bimatoprost 6 µg generation 2, bimatoprost 0.03%
Arm Type
Other
Arm Description
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.
Arm Title
bimatoprost 15 µg generation 1, bimatoprost 0.03%
Arm Type
Other
Arm Description
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.
Arm Title
bimatoprost 10 µg generation 1, bimatoprost 0.03%
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 20 µg generation 2
Intervention Description
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 15 µg generation 2
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
bimatoprost 10 µg generation 2
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
bimatoprost 6 µg generation 2
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
bimatoprost 15 µg generation 1
Intervention Description
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 10 µg generation 1
Intervention Description
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03%
Other Intervention Name(s)
LUMIGAN®
Intervention Description
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Primary Outcome Measure Information:
Title
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Description
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.
Time Frame
Baseline, Month 24
Secondary Outcome Measure Information:
Title
Time-Matched Intraocular Pressure (IOP) in the Study Eye
Description
IOP is a measurement of the fluid pressure inside the study eye.
Time Frame
Baseline to Month 6
Title
Mean Diurnal IOP in the Study Eye
Description
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.
Time Frame
Baseline, Month 6
Title
Time to Rescue Treatment or Re-Treatment in the Study Eye
Description
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.
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Doheny Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Shasta Eye Medical Group, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96002
Country
United States
Facility Name
Grutzmacher and Lewis, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Pacific Eye Surgeons
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Specialty Eye Care
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
The Eye Associates of Manatee
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Emory University, The Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Coastal Research Associates
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Glaucoma Consultants
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Tufts Medical Center/New England Eye Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
ActivMed Practices & Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Clinical Eye Research of Boston/ Charles River Eye Associates
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Moyes Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Northern New Jersey Eye Institute PA
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Glaucoma Associates of NY
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Rochester Ophthalmological Group PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
James D. Branch, MD
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Legacy Good Samaritan - Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Scott & Christie and Associates
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Keystone Research LTD
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Glaucoma Associates of TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
R and R Eye Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Focus Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Melbourne Eye Specialists
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Eye Associates
City
Sydney New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
UZ Leuven, Campus St. Rafael
City
Dienst Oogheelkunde
ZIP/Postal Code
Leuven 3000
Country
Belgium
Facility Name
Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia
City
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
A.C. S. Crichton Prof. Corp
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E-7M8
Country
Canada
Facility Name
Eye Care Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Anjema Eye Institute
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7M 5J7
Country
Canada
Facility Name
Galen Eye Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7K 6Z6
Country
Canada
Facility Name
Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Institut de l'œil des Laurentides
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 1S6
Country
Canada
Facility Name
Clarity Eye Institute
City
Vaughan
ZIP/Postal Code
L4K 0C5
Country
Canada
Facility Name
Staedtisches Klinikum Department of Opthalmology
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Kaplan Medical Center
City
Rohovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Sam Rothberg Glaucoma Center,
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Asian Eye Institute
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Pacific Eye and Laser Institute (PELI)
City
Makati City
ZIP/Postal Code
1209
Country
Philippines
Facility Name
St. Lukes Medical Center-Quezon City
City
Metro Manila
ZIP/Postal Code
Quezon City 1112
Country
Philippines
Facility Name
Singapore National Eye Center
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Valles Oftalmologia Recerca, Hospital General de Catalunya,
City
Sant Cugat
ZIP/Postal Code
08195
Country
Spain
Facility Name
Fundacion Oftalmologica Del Mediterraneo
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31884564
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.
Results Reference
background
PubMed Identifier
35643967
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.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

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