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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03850782




Registration number
NCT03850782
Ethics application status
Date submitted
11/02/2019
Date registered
22/02/2019

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
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United States of America
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Indiana
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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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Argentina
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Buenos Aires
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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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Mendoza
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Bulgaria
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Sofia
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Burgas
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Plovdiv
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Sliven
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Smolyan
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Stara Zagora
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Varna
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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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Germany
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Dresden
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Germany
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Goettingen
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Hamburg
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Muenster
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Rostock
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Germany
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Starnberg
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Heves
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Waterford
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Catania
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Chieti
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Pavia
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Perugia
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Rome
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Canterbury
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Wellington
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Mazowieckie
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Pomorskie
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Lodz
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Olsztyn
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Essex
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Oxfordshire
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Cambridge
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Chelmsford
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Colchester
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Crewe
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Liverpool
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London
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York

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03850782