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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/NCT02636946
Registration number
NCT02636946
Ethics application status
Date submitted
10/12/2015
Date registered
22/12/2015
Date last updated
23/02/2022
Titles & IDs
Public title
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
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Scientific title
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
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Secondary ID [1]
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2015-003631-34
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Secondary ID [2]
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192024-095
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glaucoma
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Open-Angle Ocular Hypertension
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bimatoprost SR
Treatment: Drugs - Sham Bimatoprost SR
Treatment: Surgery - Selective Laser Trabeculoplasty
Treatment: Surgery - Sham Selective Laser Trabeculoplasty
Active Comparator: SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) - Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 µg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 µg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
Experimental: Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) - Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 µg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 µg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Treatment: Drugs: Bimatoprost SR
Up to three Bimatoprost SR 15 micrograms (µg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 µg administrations at Day 4 and Week 16 (Stage 2).
Treatment: Drugs: Sham Bimatoprost SR
Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).
Treatment: Surgery: Selective Laser Trabeculoplasty
Selective Laser Trabeculoplasty administered on Day 1.
Treatment: Surgery: Sham Selective Laser Trabeculoplasty
Sham Selective Laser Trabeculoplasty administered on Day 1.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Intraocular Pressure (IOP) at Baseline
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Assessment method [1]
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IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
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Timepoint [1]
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Baseline (prior to treatment)
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Primary outcome [2]
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Change From Baseline in IOP at Week 4
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Assessment method [2]
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IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses.
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Timepoint [2]
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Baseline (prior to treatment) to Week 4
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Primary outcome [3]
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Change From Baseline in IOP at Week 12
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Assessment method [3]
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IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.
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Timepoint [3]
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Baseline (prior to treatment) to Week 12
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Primary outcome [4]
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Change From Baseline in Intraocular Pressure (IOP) at Week 24
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Assessment method [4]
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IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.
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Timepoint [4]
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Baseline (prior to treatment) to Week 24
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Secondary outcome [1]
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Change From Baseline in IOP at Weeks 8, 15, and 20
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Assessment method [1]
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IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.
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Timepoint [1]
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Baseline (prior to treatment) to Weeks 8, 15 and 20
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Secondary outcome [2]
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Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
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Assessment method [2]
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Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.
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Timepoint [2]
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First treatment to end of study (up to 525 days)
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Secondary outcome [3]
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Percentage of Participants With Eyes Achieving a = 20% Reduction in IOP
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Assessment method [3]
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IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3.
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Timepoint [3]
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Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20
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Eligibility
Key inclusion criteria
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require
IOP lowering treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Eye surgery (including cataract surgery) and or eye laser surgery within the past 6
months.
- Enrollment in other studies using Bimatoprost SR.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/02/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/01/2021
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Sample size
Target
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Accrual to date
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Final
144
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Marsden Eye Specialists - Parramatta
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Recruitment postcode(s) [1]
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2150 - Parramatta
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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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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Colorado
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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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Kentucky
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United States of America
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Michigan
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Missouri
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New York
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North Carolina
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North Dakota
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Pennsylvania
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Texas
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Virginia
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Denmark
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Hovedstaden
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France
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Bordeaux
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Poland
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Kuyavian-Pomeranian Voivodeship
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Poland
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Warmian-Masurian Voivodeship
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Thailand
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Chiang Mai
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Thailand
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Pathumthani
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of
Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle
glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering
medication for reasons other than medication efficacy (e.g., due to intolerance or
nonadherence).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02636946
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Margot Goodkin
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Address
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Allergan
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02636946
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