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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/NCT02507687




Registration number
NCT02507687
Ethics application status
Date submitted
22/07/2015
Date registered
24/07/2015
Date last updated
10/05/2024

Titles & IDs
Public title
Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults 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
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
Treatment: Drugs - Sham Bimatoprost SR
Treatment: Surgery - Selective Laser Trabeculoplasty
Treatment: Surgery - Sham Selective Laser Trabeculoplasty

Experimental: Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye) - Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations.
Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).

Experimental: Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye) - Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations.
Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).

Experimental: Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye) - Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met.

Experimental: Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye) - Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations.
Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met.


Treatment: Drugs: Bimatoprost SR
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.

Treatment: Drugs: Sham Bimatoprost SR
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.

Treatment: Surgery: Selective Laser Trabeculoplasty
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye.
An ophthalmologist performed 360 degrees of SLT using a standardized method.

Treatment: Surgery: Sham Selective Laser Trabeculoplasty
Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
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 at Week 4
Timepoint [1] 0 0
Baseline and Week 4
Primary outcome [2] 0 0
Change From Baseline in Intraocular Pressure at Week 12
Timepoint [2] 0 0
Baseline and Week 12
Primary outcome [3] 0 0
Change From Baseline in Intraocular Pressure at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Time to Initial Use of Non-study IOP-lowering Treatment
Timepoint [1] 0 0
From first administration of study treatment to the end of study; overall median follow-up time of 728 days.
Secondary outcome [2] 0 0
Percentage of Eyes Achieving = 20% Reduction in IOP From Baseline Regardless of Cycle
Timepoint [2] 0 0
Baseline, Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24
Secondary outcome [3] 0 0
Change From Baseline in IOP at Weeks 8, 15, and 20
Timepoint [3] 0 0
Baseline and Weeks 8, 15, and 20

Eligibility
Key inclusion criteria
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye that
require IOP lowering treatment.

- In the investigator's opinion, patient's IOP is not adequately managed with topical
medication for reasons other than medication efficacy (eg, due to intolerance or
nonadherence).

- In the investigator's opinion, both eyes can be treated adequately with topical
prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if
medication was taken as directed, or with SLT monotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of previous laser trabeculoplasty

- History or evidence of complicated cataract surgery: eg, surgery resulting in
complicated lens placement (such as anterior chamber intraocular lens implant [IOL],
sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior
capsular tear [with or without vitreous loss], substantial iris trauma, etc) or
history of phakic IOL insertion for refractive error correction

- Intraocular surgery (including cataract surgery) and/or any ocular laser surgery
within the 6 months prior to treatment

- Previous use of commercially available Bimatoprost SR; concurrent enrollment in
another Allergan Bimatoprost SR study; or previous enrollment in which an implant was
received.

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
27/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2023
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Queensland Eye Institute /ID# 236074 - South Brisbane
Recruitment hospital [2] 0 0
Eye Surgery Associates /ID# 235872 - East Melbourne
Recruitment hospital [3] 0 0
Melbourne Eye Specialists /ID# 234614 - Fitzroy
Recruitment hospital [4] 0 0
Waverley Eye Clinic /ID# 234997 - Glen Waverley
Recruitment hospital [5] 0 0
The Lions Eye Institute /ID# 236832 - Nedlands
Recruitment hospital [6] 0 0
Essendon Eye Clinic /ID# 235433 - Essendon
Recruitment hospital [7] 0 0
Geelong Eye Clinic /ID# 236118 - Geelong
Recruitment hospital [8] 0 0
Vision Eye Institute /ID# 236003 - Melbourne
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
VIC3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3150 - Glen Waverley
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
3040 - Essendon
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3058 - Melbourne
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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
North Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Denmark
State/province [24] 0 0
Hovedstaden
Country [25] 0 0
France
State/province [25] 0 0
Angers
Country [26] 0 0
France
State/province [26] 0 0
Avranches
Country [27] 0 0
France
State/province [27] 0 0
Bordeaux
Country [28] 0 0
France
State/province [28] 0 0
Montauban
Country [29] 0 0
France
State/province [29] 0 0
Nice
Country [30] 0 0
France
State/province [30] 0 0
Strasbourg cedex
Country [31] 0 0
France
State/province [31] 0 0
Toulouse
Country [32] 0 0
Germany
State/province [32] 0 0
Nordrhein-Westfalen
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Magdeburg
Country [35] 0 0
Israel
State/province [35] 0 0
Tel-Aviv
Country [36] 0 0
Israel
State/province [36] 0 0
Haifa
Country [37] 0 0
Israel
State/province [37] 0 0
Nahariya
Country [38] 0 0
Israel
State/province [38] 0 0
Petakh Tikva
Country [39] 0 0
New Zealand
State/province [39] 0 0
Auckland
Country [40] 0 0
New Zealand
State/province [40] 0 0
Canterbury
Country [41] 0 0
New Zealand
State/province [41] 0 0
Wellington
Country [42] 0 0
Philippines
State/province [42] 0 0
Makati City
Country [43] 0 0
Philippines
State/province [43] 0 0
San Juan City
Country [44] 0 0
Poland
State/province [44] 0 0
Olsztyn
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Omsk
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Samara
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Derbyshire
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Kent
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London, City Of
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Surrey
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Cambridge
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Edinburgh
Country [53] 0 0
United Kingdom
State/province [53] 0 0
London
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the intraocular pressure (IOP)-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 for reasons other than medication efficacy (e.g., due to intolerance or
nonadherence).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02507687
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/NCT02507687