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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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.
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 to Week 12 (Hours 0 and 2)
Timepoint [1] 0 0
Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)
Primary outcome [2] 0 0
IOP in the Study Eye at Week 2 (Hour 0)
Timepoint [2] 0 0
Week 2 (Hour 0)
Primary outcome [3] 0 0
IOP in the Study Eye at Week 2 (Hour 2)
Timepoint [3] 0 0
Week 2 (Hour 2)
Primary outcome [4] 0 0
IOP in the Study Eye at Week 6 (Hour 0)
Timepoint [4] 0 0
Week 6 (Hour 0)
Primary outcome [5] 0 0
IOP in the Study Eye at Week 6 (Hour 2)
Timepoint [5] 0 0
Week 6 (Hour 2)
Primary outcome [6] 0 0
IOP in the Study Eye at Week 12 (Hour 0)
Timepoint [6] 0 0
Week 12 (Hour 0)
Primary outcome [7] 0 0
IOP in the Study Eye at Week 12 (Hour 2)
Timepoint [7] 0 0
Week 12 (Hour 2)
Secondary outcome [1] 0 0
Change From Baseline in IOP in the Study Eye
Timepoint [1] 0 0
Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/07/2020
Sample size
Target
Accrual to date
Final
528
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
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United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
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New Jersey
Country [15] 0 0
United States of America
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New Mexico
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United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
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North Carolina
Country [18] 0 0
United States of America
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North Dakota
Country [19] 0 0
United States of America
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Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autónoma de BuenosAires
Country [28] 0 0
Argentina
State/province [28] 0 0
Mendoza
Country [29] 0 0
Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Canada
State/province [30] 0 0
Nova Scotia
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Colombia
State/province [33] 0 0
Antioquia
Country [34] 0 0
Colombia
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Distrito Capital De Bogota
Country [35] 0 0
Colombia
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Santander
Country [36] 0 0
Colombia
State/province [36] 0 0
Cali
Country [37] 0 0
Czechia
State/province [37] 0 0
Jihlavska
Country [38] 0 0
Czechia
State/province [38] 0 0
Sokolska
Country [39] 0 0
Czechia
State/province [39] 0 0
Prague
Country [40] 0 0
Egypt
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Cairo
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Germany
State/province [41] 0 0
Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Mainz
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Italy
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Abruzzo
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Italy
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Lombardia
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Milano
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Italy
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Perugia
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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New Zealand
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Wellington
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Singapore
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Singapore
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South Africa
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Free State
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South Africa
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Pretoria
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Turkey
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Eskisehir
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Turkey
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Istanbul
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Turkey
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Manisa
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United Kingdom
State/province [60] 0 0
Cambridge
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United Kingdom
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Cosham
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United Kingdom
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Edinburgh
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United Kingdom
State/province [63] 0 0
Great Yarmouth
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United Kingdom
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Liverpool
Country [65] 0 0
United Kingdom
State/province [65] 0 0
London
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Peterborough

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02250651