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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02250651
Registration number
NCT02250651
Ethics application status
Date submitted
23/09/2014
Date registered
26/09/2014
Date last updated
28/07/2021
Titles & IDs
Public title
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
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Scientific title
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
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Secondary ID [1]
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2014-003186-24
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Secondary ID [2]
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192024-092
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glaucoma, Open-Angle
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Ocular Hypertension
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bimatoprost SR
Other interventions - Sham: Applicator Without Needle
Treatment: Drugs - Active Comparator: Timolol 0.5%
Treatment: Drugs - Timolol Vehicle (placebo)
Experimental: Bimatoprost SR 15 µg - Study Eye: bimatoprost sustained-release (SR) 15 micrograms (µg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Experimental: Bimatoprost SR 10 µg - Study Eye: bimatoprost SR 10 µg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Active Comparator: Timolol 0.5%: Comparator - Both Eyes: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Treatment: Drugs: Bimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Other interventions: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Treatment: Drugs: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Treatment: Drugs: Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)
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Assessment method [1]
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IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
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Timepoint [1]
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Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)
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Primary outcome [2]
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IOP in the Study Eye at Week 2 (Hour 0)
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Assessment method [2]
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IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
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Timepoint [2]
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Week 2 (Hour 0)
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Primary outcome [3]
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IOP in the Study Eye at Week 2 (Hour 2)
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Assessment method [3]
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IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
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Timepoint [3]
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Week 2 (Hour 2)
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Primary outcome [4]
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IOP in the Study Eye at Week 6 (Hour 0)
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Assessment method [4]
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IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
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Timepoint [4]
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Week 6 (Hour 0)
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Primary outcome [5]
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IOP in the Study Eye at Week 6 (Hour 2)
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Assessment method [5]
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IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
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Timepoint [5]
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Week 6 (Hour 2)
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Primary outcome [6]
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IOP in the Study Eye at Week 12 (Hour 0)
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Assessment method [6]
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IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
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Timepoint [6]
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Week 12 (Hour 0)
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Primary outcome [7]
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IOP in the Study Eye at Week 12 (Hour 2)
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Assessment method [7]
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IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
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Timepoint [7]
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Week 12 (Hour 2)
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Secondary outcome [1]
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Change From Baseline in IOP in the Study Eye
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Assessment method [1]
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IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
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Timepoint [1]
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Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)
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Eligibility
Key inclusion criteria
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes
require IOP-lowering treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Previous enrollment in another Allergan Bimatoprost SR Study
- Eye surgery (including cataract surgery) and/or any eye laser surgery within the past
6 months in the study eye
- Anticipated need for laser eye surgery within the first 52 weeks of the study duration
- History of glaucoma surgery
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/12/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/07/2020
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Sample size
Target
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Accrual to date
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Final
528
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Recruitment in Australia
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in
patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month
treatment period with an 8-month extended follow-up.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02250651
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Margot Goodkin
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Address
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Allergan
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02250651
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