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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02250651




Registration number
NCT02250651
Ethics application status
Date submitted
23/09/2014
Date registered
26/09/2014
Date last updated
19/12/2018

Titles & IDs
Public title
Safety and Efficacy of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Scientific title
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
Secondary ID [1] 0 0
2014-003186-24
Secondary ID [2] 0 0
192024-092
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma, Open-Angle 0 0
Ocular Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bimatoprost sustained-release
Other interventions - Sham
Treatment: Drugs - Timolol
Treatment: Drugs - Timolol Vehicle (placebo)

Experimental: Bimatoprost SR Dose A - Study Eye: bimatoprost sustained-release (SR) Dose A administered on Day 1, Week 16, and Week 32; 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, Week 16, and Week 32; timolol administered once in the morning and once in the evening for up to 20 months.

Experimental: Bimatoprost SR Dose B - Study Eye: bimatoprost SR Dose B administered on Day 1, Week 16, and Week 32; 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, Week 16, and Week 32; timolol administered once in the morning and once in the evening for up to 20 months.

Sham Comparator: Sham - Both Eyes: sham administered on Day 1, Week 16, and Week 32; timolol administered once in the morning and once in the evening for up to 20 months.


Treatment: Drugs: Bimatoprost sustained-release
Bimatoprost sustained-release (SR) administered in the study eye on Day 1, Week 16, and Week 32.

Other interventions: Sham
Sham administered on Day 1, Week 16, and Week 32, as per protocol.

Treatment: Drugs: Timolol
Timolol administered once in the morning and once in the evening for up to 20 months, as per protocol.

Treatment: Drugs: Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months, as per protocol.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Intraocular Pressure (IOP) in the Study Eye
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
IOP in the Study Eye
Timepoint [2] 0 0
Week 2
Primary outcome [3] 0 0
IOP in the Study Eye
Timepoint [3] 0 0
Week 6
Primary outcome [4] 0 0
IOP in the Study Eye
Timepoint [4] 0 0
Week 12
Secondary outcome [1] 0 0
Change from Baseline in IOP in the Study Eye
Timepoint [1] 0 0
Baseline, Week 2, Week 6

Eligibility
Key inclusion criteria
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes
require IOP-lowering treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Alabama
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Illinois
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Ciudad Autónoma de BuenosAires
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Argentina
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Pilar
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Eskisehir
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Istanbul
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Manisa
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Cambridge
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Edinburgh
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Great Yarmouth
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Huntingdon
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Liverpool
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London
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Portsmouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02250651
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Margot Goodkin
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications