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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

July 2, 2010
July 7, 2010
January 16, 2018
September 23, 2010
July 27, 2016   (Final data collection date for primary outcome measure)
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.
Intraocular Pressure [ Time Frame: Month 12 ]
Complete list of historical versions of study NCT01157364 on ClinicalTrials.gov Archive Site
  • 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.
  • Time to Escape Treatment [ Time Frame: 24 Months ]
  • Time to Second Injection [ Time Frame: 24 Months ]
Not Provided
Not Provided
Not Provided
 
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 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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Open-Angle Glaucoma
  • Ocular Hypertension
  • Drug: bimatoprost 20 µg generation 2
    Single dose of bimatoprost ophthalmic formulation A administered in the study eye on Day 1.
  • 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 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 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 15 µg generation 1
    Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
  • 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®
  • 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.
    Interventions:
    • Drug: bimatoprost 20 µg generation 2
    • Drug: bimatoprost 0.03%
  • 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.
    Interventions:
    • Drug: bimatoprost 15 µg generation 2
    • Drug: bimatoprost 0.03%
  • 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.
    Interventions:
    • Drug: bimatoprost 10 µg generation 2
    • Drug: bimatoprost 0.03%
  • 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.
    Interventions:
    • Drug: bimatoprost 6 µg generation 2
    • Drug: bimatoprost 0.03%
  • 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.
    Interventions:
    • Drug: bimatoprost 15 µg generation 1
    • Drug: bimatoprost 0.03%
  • 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.
    Interventions:
    • Drug: bimatoprost 10 µg generation 1
    • Drug: bimatoprost 0.03%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
12
August 4, 2017
July 27, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of open angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Anticipated wearing of contact lenses during the study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Canada,   Germany,   Israel,   Philippines,   Singapore,   Spain,   United States
 
 
NCT01157364
192024-041D
2011-005091-42 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP