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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02247804
Registration number
NCT02247804
Ethics application status
Date submitted
22/09/2014
Date registered
25/09/2014
Date last updated
11/06/2020
Titles & IDs
Public title
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants 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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2014-003037-26
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Secondary ID [2]
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192024-091
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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
Treatment: Drugs - Active Comparator: Timolol 0.5%
Other interventions - Sham: Applicator Without Needle
Treatment: Drugs - Timolol Vehicle (placebo)
Experimental: Bimatoprost SR 15 µg - Study Eye: bimatoprost sustained release (SR) 15 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% - Study Eye and Non-Study Eye: 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.
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.
Other interventions: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
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 IOP in the Study Eye at 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 (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 (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 in either eye 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 administering 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
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Actual
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Date of last data collection
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Actual
19/07/2019
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Sample size
Target
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Accrual to date
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Final
594
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Vision Eye Institute Chatswood - Chatsworth
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Recruitment hospital [2]
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Melbourne Eye Specialists - Fitzroy
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Recruitment hospital [3]
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Waverley Eye Clinic - Glen Waverley
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Marsden Eye Specialists, Parramatta - Paramatta
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Recruitment hospital [5]
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Preston Eye Clinic - Preston
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New South Wales - Chatsworth
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Victoria 3065 - Fitzroy
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Vctoria 3150 - Glen Waverley
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New South Wales - Paramatta
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Recruitment postcode(s) [5]
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Victoria 3072 - Preston
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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 SR in participants 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/study/NCT02247804
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Trial related presentations / publications
Weinreb RN, Bacharach J, Brubaker JW, Medeiros FA, Bejanian M, Bernstein P, Robinson MR. Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):55-62. doi: 10.1089/jop.2022.0137. Epub 2022 Nov 15. Medeiros FA, Sheybani A, Shah MM, Rivas M, Bai Z, Werts E, Ahmed IIK, Craven ER. Single Administration of Intracameral Bimatoprost Implant 10 microg in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.
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Public notes
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Contacts
Principal investigator
Name
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Marina Bejanian
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Address
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Allergan
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/04/NCT02247804/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/04/NCT02247804/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02247804
Download to PDF