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

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ClinicalTrials.gov Identifier: NCT01157364
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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 formulations will be evaluated based on internal data review of each cohort. The study will be conducted in 2 stages. Stage 1 is open-label and Stage 2 is masked.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: bimatoprost 20 µg generation 2 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 Drug: bimatoprost 0.03% Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 23, 2010
Primary Completion Date : July 27, 2016
Study Completion Date : August 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Bimatoprost
U.S. FDA Resources

Arm Intervention/treatment
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 formulation A 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 Name: LUMIGAN®
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 15 µg generation 2
Single dose of bimatoprost ophthalmic formulation B administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
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 Name: LUMIGAN®
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 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).
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 Name: LUMIGAN®
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 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).
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 Name: LUMIGAN®
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 15 µg generation 1
Single dose of bimatoprost ophthalmic 15 µg generation 1 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 Name: LUMIGAN®
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 10 µg generation 1
Single dose of bimatoprost ophthalmic 10 µg generation 1 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 Name: LUMIGAN®



Primary Outcome Measures :
  1. Change from Baseline in Cycle 1 Time-Matched Intraocular Pressure (IOP) in the Study Eye for Generation 2 Groups [ Time Frame: Baseline, Month 24 ]
    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.


Secondary Outcome Measures :
  1. Change from Baseline in Cycle 1 Mean Diurnal IOP in the Study Eye for Generation 2 Groups [ 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. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

  2. Time to Escape Treatment [ Time Frame: 24 Months ]
  3. Time to Second Injection [ Time Frame: 24 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of open angle glaucoma or ocular hypertension

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157364


  Show 57 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01157364     History of Changes
Other Study ID Numbers: 192024-041D
2011-005091-42 ( EudraCT Number )
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Bimatoprost
Pharmaceutical Solutions
Antihypertensive Agents