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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02507687




Registration number
NCT02507687
Ethics application status
Date submitted
22/07/2015
Date registered
24/07/2015
Date last updated
9/07/2019

Titles & IDs
Public title
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
2015-002131-18
Secondary ID [2] 0 0
192024-093
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
Cardiovascular 0 0 0 0
Hypertension
Eye 0 0 0 0
Diseases / disorders of the eye

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

Experimental: Bimatoprost Sustained-Release (SR) - Assigned Primary Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Bimatoprost SR Dose A administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR Dose B administrations at Day 4 and Week 16 (Stage 2).
Contralateral Eye: SLT administered on Day 1 followed by 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).

Active Comparator: Selective Laser Trabeculoplasty (SLT) - Assigned Primary Eye: SLT administered on Day 1 followed by 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).
Contralateral Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR Dose A administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR Dose B administrations at Day 4 and Week 16 (Stage 2).


Treatment: Drugs: Bimatoprost SR
Up to three Bimatoprost SR Dose A administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR Dose B 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
Change from Baseline in Intraocular Pressure (IOP) at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
Change from Baseline in IOP at Week 4
Timepoint [2] 0 0
Baseline, Week 4
Primary outcome [3] 0 0
Change from Baseline in IOP at Week 12
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
IOP change from baseline time-weighted average through Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
IOP change from baseline at Week 8
Timepoint [2] 0 0
Baseline, Week 8
Secondary outcome [3] 0 0
IOP change from baseline at Week 15
Timepoint [3] 0 0
Baseline, Week 15
Secondary outcome [4] 0 0
IOP change from baseline at Week 20
Timepoint [4] 0 0
Baseline, Week 20
Secondary outcome [5] 0 0
IOP at each visit
Timepoint [5] 0 0
24 Weeks
Secondary outcome [6] 0 0
Time to onset of effect (time to first achieving
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Time to initial use of nonstudy IOP-lowering treatment as determined by the investigator
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Percentage of Bimatoprost SR eyes achieving = 20% reduction at Week 4
Timepoint [8] 0 0
Baseline, Week 4
Secondary outcome [9] 0 0
Percentage of Bimatoprost SR eyes achieving = 20% reduction at Week 12
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Percentage of Bimatoprost SR eyes achieving = 20% reduction at Week 24
Timepoint [10] 0 0
Baseline, Week 24
Secondary outcome [11] 0 0
Percentage of SLT eyes achieving = 20% reduction at Week 4
Timepoint [11] 0 0
Baseline, Week 4
Secondary outcome [12] 0 0
Percentage of SLT eyes achieving = 20% reduction at Week 12
Timepoint [12] 0 0
Baseline, Week 12
Secondary outcome [13] 0 0
Percentage of SLT eyes achieving = 20% reduction at Week 24
Timepoint [13] 0 0
Baseline, Week 24

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
Gender
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
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
Recruiting
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)
VIC,WA
Recruitment hospital [1] 0 0
Essendon Eye Clinic - Essendon
Recruitment hospital [2] 0 0
Melbourne Eye Specialists - Fitzroy
Recruitment hospital [3] 0 0
Geelong Eye Clinic - Geelong
Recruitment hospital [4] 0 0
Waverley Eye Clinic - Glen Waverley
Recruitment hospital [5] 0 0
Vision Eye Institute - Melbourne
Recruitment hospital [6] 0 0
The University of Western Australia - Lions Eye Institute - Crawley
Recruitment postcode(s) [1] 0 0
3040 - Essendon
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3150 - Glen Waverley
Recruitment postcode(s) [5] 0 0
3058 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Crawley
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
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
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
West Virginia
Country [21] 0 0
Canada
State/province [21] 0 0
Nova Scotia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Canada
State/province [24] 0 0
Mississauga
Country [25] 0 0
Estonia
State/province [25] 0 0
Kohtla-Jarve
Country [26] 0 0
Estonia
State/province [26] 0 0
Tallinn
Country [27] 0 0
Estonia
State/province [27] 0 0
Tartu
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Dusseldorf
Country [30] 0 0
Germany
State/province [30] 0 0
Greifswald
Country [31] 0 0
Germany
State/province [31] 0 0
Magdeburg
Country [32] 0 0
Germany
State/province [32] 0 0
Munchen
Country [33] 0 0
Germany
State/province [33] 0 0
Munster
Country [34] 0 0
Germany
State/province [34] 0 0
Ulm
Country [35] 0 0
Israel
State/province [35] 0 0
Haifa
Country [36] 0 0
Israel
State/province [36] 0 0
Petach Tiqva
Country [37] 0 0
Israel
State/province [37] 0 0
Ramat Gan
Country [38] 0 0
Israel
State/province [38] 0 0
Tel Aviv
Country [39] 0 0
New Zealand
State/province [39] 0 0
Remuera
Country [40] 0 0
New Zealand
State/province [40] 0 0
Wellington
Country [41] 0 0
Philippines
State/province [41] 0 0
Metro Manila
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Birmingham
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Bristol
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Cambridge
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Derby
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Edinburgh
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Manchester
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Portsmouth
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Sidcup

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 intraocular pressure-lowering effect and safety of Bimatoprost
SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or
ocular hypertension who are not adequately managed with topical IOP-lowering medication.
Trial website
https://clinicaltrials.gov/show/NCT02507687
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
Clinical Trial Registry Team
Address 0 0
Country 0 0
Phone 0 0
877-277-8566
Fax 0 0
Email 0 0
IR-CTRegistration@allergan.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02507687