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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/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
Scientific title
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
Secondary ID [1] 0 0
2014-003037-26
Secondary ID [2] 0 0
192024-091
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
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.
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 IOP in the Study Eye at Week 12 (Hours 0 and 2)
Timepoint [1] 0 0
Baseline (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 (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 in either eye 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 administering 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
19/07/2019
Sample size
Target
Accrual to date
Final
594
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Vision Eye Institute Chatswood - Chatsworth
Recruitment hospital [2] 0 0
Melbourne Eye Specialists - Fitzroy
Recruitment hospital [3] 0 0
Waverley Eye Clinic - Glen Waverley
Recruitment hospital [4] 0 0
Marsden Eye Specialists, Parramatta - Paramatta
Recruitment hospital [5] 0 0
Preston Eye Clinic - Preston
Recruitment postcode(s) [1] 0 0
New South Wales - Chatsworth
Recruitment postcode(s) [2] 0 0
Victoria 3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
Vctoria 3150 - Glen Waverley
Recruitment postcode(s) [4] 0 0
New South Wales - Paramatta
Recruitment postcode(s) [5] 0 0
Victoria 3072 - Preston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
State/province [3] 0 0
Colorado
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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Kansas
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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West Virginia
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Austria
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Graz
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Vienna
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Belgium
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Leuven
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Belgium
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Liege
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Brazil
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Goias
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Brazil
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Minas Gerais
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Brazil
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Sao Paulo
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Brazil
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Rio Verde
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Denmark
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Glostrup
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Hong Kong
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Hong Kong
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Hungary
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Pecs
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Hungary
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Szombathely
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Hungary
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Zalaegerszeg
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Israel
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Ashkelon
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Haifa
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Lima
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Philippines
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Makati
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Bydgoszcz
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Gdansk
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Lublin
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Nowy Targ
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Olsztyn
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Warsaw
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Barcelona
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Cordoba
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Sevilla
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Valencia
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Valladolid
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Zaragoza
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Taiwan
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Hualien
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Taiwan
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Kaohsiung

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02247804
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marina Bejanian
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