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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - 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.
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) - 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.
Timepoint [2] 0 0
Week 2 (Hour 0)
Primary outcome [3] 0 0
IOP in the Study Eye at Week 2 (Hour 2) - 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.
Timepoint [3] 0 0
Week 2 (Hour 2)
Primary outcome [4] 0 0
IOP in the Study Eye at Week 6 (Hour 0) - 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.
Timepoint [4] 0 0
Week 6 (Hour 0)
Primary outcome [5] 0 0
IOP in the Study Eye at Week 6 (Hour 2) - 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.
Timepoint [5] 0 0
Week 6 (Hour 2)
Primary outcome [6] 0 0
IOP in the Study Eye at Week 12 (Hour 0) - 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.
Timepoint [6] 0 0
Week 12 (Hour 0)
Primary outcome [7] 0 0
IOP in the Study Eye at Week 12 (Hour 2) - 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.
Timepoint [7] 0 0
Week 12 (Hour 2)
Secondary outcome [1] 0 0
Change From Baseline in IOP in the Study Eye - 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.
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
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 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
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 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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
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
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
West Virginia
Country [26] 0 0
Austria
State/province [26] 0 0
Graz
Country [27] 0 0
Austria
State/province [27] 0 0
Vienna
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Liege
Country [30] 0 0
Brazil
State/province [30] 0 0
Goias
Country [31] 0 0
Brazil
State/province [31] 0 0
Minas Gerais
Country [32] 0 0
Brazil
State/province [32] 0 0
Sao Paulo
Country [33] 0 0
Brazil
State/province [33] 0 0
Rio Verde
Country [34] 0 0
Denmark
State/province [34] 0 0
Glostrup
Country [35] 0 0
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
Country [38] 0 0
Hungary
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Zalaegerszeg
Country [39] 0 0
Israel
State/province [39] 0 0
Ashkelon
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Israel
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Haifa
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Peru
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Lima
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Philippines
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Makati
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Lublin
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Poland
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Nowy Targ
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Poland
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Olsztyn
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Poland
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Warsaw
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Poland
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Warszawa
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Poland
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Wroclaw
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Valladolid
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Spain
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Zaragoza
Country [58] 0 0
Taiwan
State/province [58] 0 0
Hualien
Country [59] 0 0
Taiwan
State/province [59] 0 0
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/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

Summary results
Other publications