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

March 27, 2020 updated by: Allergan

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Time Frame: Baseline, Month 24
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-Matched Intraocular Pressure (IOP) in the Study Eye
Time Frame: Baseline to Month 6
IOP is a measurement of the fluid pressure inside the study eye.
Baseline to Month 6
Mean Diurnal IOP in the Study Eye
Time Frame: Baseline, Month 6
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 Frame: 24 Months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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