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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/NCT03850782




Registration number
NCT03850782
Ethics application status
Date submitted
11/02/2019
Date registered
22/02/2019
Date last updated
13/02/2024

Titles & IDs
Public title
Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Scientific title
A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Secondary ID [1] 0 0
2018-002574-52
Secondary ID [2] 0 0
1698-301-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open-Angle Glaucoma 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Bimatoprost (SR)

Experimental: Bimatoprost SR - Dose A - Study Eye: Participants will receive 1 - 2 Cycles of Bimatoprost SR administrations of Dose A
Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.

Experimental: Bimatoprost SR - Dose B - Study Eye: Participants received 1 - 3 Cycles of Bimatoprost SR administrations of Dose B
Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.


Treatment: Drugs: Bimatoprost (SR)
Study Eye: Cycles 1 - 3 administrations through the PRN treatment period.
Fellow Eye: Standard of care or Bimatoprost SR.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Retreatment or rescue administered for IOP
Timepoint [1] 0 0
Up to 48 months
Primary outcome [2] 0 0
Number of patients experiencing a treatment emergent adverse event
Timepoint [2] 0 0
Baseline up to 48 months

Eligibility
Key inclusion criteria
- Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation
glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular
pressure-lowering treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Concurrent or anticipated enrollment in another investigational drug or device study
or participation in such a study within 2 months prior to enrolling in this study.

- Previous administration with Bimatoprost SR in the study eye.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
28/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/08/2025
Actual
Sample size
Target
Accrual to date
Final
515
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Eye Surgery Associates /ID# 235873 - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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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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Indiana
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United States of America
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Louisiana
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Massachusetts
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Michigan
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Missouri
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad de Buenos Aires
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Argentina
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Mendoza
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Bulgaria
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Sofia
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Bulgaria
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Burgas
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Bulgaria
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Plovdiv
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Bulgaria
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Sliven
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Bulgaria
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Smolyan
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Bulgaria
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Stara Zagora
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Bulgaria
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Varna
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Czechia
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Pardubice
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Czechia
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Praha
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Denmark
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Hovedstaden
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Germany
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Baden-Wuerttemberg
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Germany
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Schleswig-Holstein
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Germany
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Dresden
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Germany
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Goettingen
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Germany
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Hamburg
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Germany
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Muenster
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Germany
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Neubrandenburg
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Germany
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Rostock
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Germany
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Starnberg
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Hungary
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Heves
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Hungary
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Vas
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Hungary
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Budapest
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Ireland
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Dublin
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Ireland
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Waterford
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Italy
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Calabria
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Italy
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Catania
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Italy
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Chieti
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Italy
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Pavia
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Italy
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Perugia
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Italy
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Rome
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Italy
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Terracina
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New Zealand
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Canterbury
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New Zealand
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Wellington
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Poland
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Mazowieckie
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Poland
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Pomorskie
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Poland
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Katowice
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Poland
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Lodz
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Poland
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Olsztyn
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Russian Federation
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Novosibirsk
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South Africa
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Gauteng
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South Africa
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Western Cape
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Sweden
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Vasterbottens Lan
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United Kingdom
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Essex
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United Kingdom
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Oxfordshire
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United Kingdom
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Cambridge
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United Kingdom
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Chelmsford
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Colchester
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United Kingdom
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Crewe
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
State/province [76] 0 0
York

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

Ethics approval
Ethics application status

Summary
Brief summary
This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of
as needed administrations of Bimatoprost sustained release (SR) in participants with
open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with
topical IOP-lowering medication for reasons other than medication efficacy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03850782
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03850782