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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02636946




Registration number
NCT02636946
Ethics application status
Date submitted
10/12/2015
Date registered
22/12/2015

Titles & IDs
Public title
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Scientific title
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Secondary ID [1] 0 0
2015-003631-34
Secondary ID [2] 0 0
192024-095
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 0 0
Open-Angle 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 - 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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Intraocular Pressure (IOP) at Baseline
Timepoint [1] 0 0
Baseline (prior to treatment)
Primary outcome [2] 0 0
Change From Baseline in IOP at Week 4
Timepoint [2] 0 0
Baseline (prior to treatment) to Week 4
Primary outcome [3] 0 0
Change From Baseline in IOP at Week 12
Timepoint [3] 0 0
Baseline (prior to treatment) to Week 12
Primary outcome [4] 0 0
Change From Baseline in Intraocular Pressure (IOP) at Week 24
Timepoint [4] 0 0
Baseline (prior to treatment) to Week 24
Secondary outcome [1] 0 0
Change From Baseline in IOP at Weeks 8, 15, and 20
Timepoint [1] 0 0
Baseline (prior to treatment) to Weeks 8, 15 and 20
Secondary outcome [2] 0 0
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
Timepoint [2] 0 0
First treatment to end of study (up to 525 days)
Secondary outcome [3] 0 0
Percentage of Participants With Eyes Achieving a = 20% Reduction in IOP
Timepoint [3] 0 0
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

Eligibility
Key inclusion criteria
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that 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
* Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
* Enrollment in other studies using Bimatoprost SR.

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
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
24/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/01/2021
Sample size
Target
Accrual to date
Final
144
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Marsden Eye Specialists - Parramatta
Recruitment postcode(s) [1] 0 0
2150 - Parramatta
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
North Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Denmark
State/province [16] 0 0
Hovedstaden
Country [17] 0 0
France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
Poland
State/province [18] 0 0
Kuyavian-Pomeranian Voivodeship
Country [19] 0 0
Poland
State/province [19] 0 0
Warmian-Masurian Voivodeship
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Novosibirsk
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Omsk
Country [22] 0 0
Singapore
State/province [22] 0 0
Singapore
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Thailand
State/province [25] 0 0
Chiang Mai
Country [26] 0 0
Thailand
State/province [26] 0 0
Pathumthani

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Margot Goodkin
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

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 and 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, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02636946