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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01157364
First received: July 2, 2010
Last updated: October 20, 2016
Last verified: October 2016
July 2, 2010
October 20, 2016
August 2010
July 2016   (Final data collection date for primary outcome measure)
  • Stage 1: Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 24 Months ]
  • Stage 2: Change from Baseline in IOP [ Time Frame: Baseline, 24 Months ]
Intraocular Pressure [ Time Frame: Month 12 ]
Complete list of historical versions of study NCT01157364 on ClinicalTrials.gov Archive Site
  • Stage 2: IOP [ Time Frame: 24 Months ]
  • 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
Not Provided
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 ophthalmic formulation A
    Single dose of bimatoprost ophthalmic formulation A administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
  • Drug: bimatoprost ophthalmic formulation B
    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 ophthalmic formulation C
    Single dose of bimatoprost ophthalmic formulation C administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
  • Drug: bimatoprost ophthalmic formulation D
    Single dose of bimatoprost ophthalmic formulation D administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
  • Drug: bimatoprost ophthalmic formulation E
    Single dose of bimatoprost ophthalmic formulation E administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
  • Drug: bimatoprost ophthalmic formulation F
    Single dose of bimatoprost ophthalmic formulation F administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
  • Drug: Sham
    Sham administration in the study eye on Day 1.
  • Drug: timolol 0.5%
    Two drops timolol 0.5% (Timoptic®) administered in the study and non-study eyes once in the morning and once in the evening daily for up to 24 months.
    Other Name: Timoptic®
  • Drug: bimatoprost ophthalmic solution 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®
  • Drug: latanoprost 0.005%
    One drop latanoprost 0.005% (Xalatan®) administered in the non-study eye once daily in the evening or in the non-study eye and study eye once daily in the evening for up to 24 months.
    Other Name: Xalatan®
  • Drug: timolol vehicle (placebo)
    One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle administered in the non-study eye once daily in the morning, or 1 drop of timolol vehicle administered once in the morning in both eyes for up to 24 months. Timolol vehicle is administered for masking purposes.
  • Stage 1: bimatoprost formulation A, bimatoprost 0.03%
    Single dose of bimatoprost ophthalmic formulation A 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 ophthalmic formulation A
    • Drug: bimatoprost ophthalmic solution 0.03%
  • Stage 1: bimatoprost formulation B, bimatoprost 0.03%
    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). 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 ophthalmic formulation B
    • Drug: bimatoprost ophthalmic solution 0.03%
  • Stage 1: bimatoprost formulation C, bimatoprost 0.03%
    Single dose of bimatoprost ophthalmic formulation C 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 ophthalmic formulation C
    • Drug: bimatoprost ophthalmic solution 0.03%
  • Stage 2: bimatoprost formulation D, latanoprost 0.005%
    Single dose of bimatoprost ophthalmic formulation D administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop latanoprost 0.005% (Xalatan®) administered once daily every evening in the non-study eye for up to 24 months. One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle (for masking purposes) administered in the non-study eye once daily in the morning for up to 24 months.
    Interventions:
    • Drug: bimatoprost ophthalmic formulation D
    • Drug: latanoprost 0.005%
    • Drug: timolol vehicle (placebo)
  • Stage 2: bimatoprost formulation E, latanoprost 0.005%
    Single dose of bimatoprost ophthalmic formulation E administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop latanoprost 0.005% (Xalatan®) administered once daily every evening in the non-study eye for up to 24 months. One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle (for masking purposes) administered in the non-study eye once daily in the morning for up to 24 months.
    Interventions:
    • Drug: bimatoprost ophthalmic formulation E
    • Drug: latanoprost 0.005%
    • Drug: timolol vehicle (placebo)
  • Stage 2: bimatoprost formulation F, latanoprost 0.005%
    Single dose of bimatoprost ophthalmic formulation F administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop latanoprost 0.005% (Xalatan®) administered once daily every evening in the non-study eye for up to 24 months. One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle (for masking purposes) administered in the non-study eye once daily in the morning for up to 24 months.
    Interventions:
    • Drug: bimatoprost ophthalmic formulation F
    • Drug: latanoprost 0.005%
    • Drug: timolol vehicle (placebo)
  • Stage 2: Sham, latanoprost 0.005%
    Sham administration in the study eye on Day 1. One drop of latanoprost 0.005% (Xalatan®) administered once daily in the evening in the study eye and non-study eye for up to 24 months. One drop of timolol vehicle (for masking purposes) administered once in the morning in both eyes for up to 24 months.
    Interventions:
    • Drug: Sham
    • Drug: latanoprost 0.005%
    • Drug: timolol vehicle (placebo)
  • Stage 2: Sham, timolol 0.5%
    Sham administration in the study eye on Day 1. Two drops of timolol 0.5% (Timoptic®) administered in the study and non-study eyes once in the morning and once in the evening daily for up to 24 months.
    Interventions:
    • Drug: Sham
    • Drug: timolol 0.5%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
July 2016
July 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
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
October 2016

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