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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03362931




Registration number
NCT03362931
Ethics application status
Date submitted
30/11/2017
Date registered
5/12/2017
Date last updated
24/03/2020

Titles & IDs
Public title
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
Scientific title
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
Secondary ID [1] 0 0
1924-701-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma, Angle-Closure 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - XEN45

Experimental: XEN45 Glaucoma Treatment System (hereafter referred to as XEN) - XEN45 unilaterally implanted in the study eye


Treatment: Devices: XEN45
XEN45 unilaterally implanted in the study eye

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients achieving at least a 20% reduction from baseline Hour 0 IOP while on the same number or fewer IOP lowering medications - IOP will be measured using a Goldmann applanation tonometer
Timepoint [1] 0 0
Baseline to Month 12
Secondary outcome [1] 0 0
Change from baseline the number of concomitant IOP-lowering medications - The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.
Timepoint [1] 0 0
Baseline to Month 12

Eligibility
Key inclusion criteria
- Diagnosis of ACG defined as areas of iridotrabecular contact present in = 2 quadrants
and glaucomatous damage to optic disc and visual field, in the study eye

- Study eye has healthy, free, and mobile conjunctiva in the target quadrant
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Uncontrolled systemic disease (eg, diabetes, hypertension)

- Known history of bleeding disorder or prolonged bleeding after surgery or those on
pharmacologic blood thinners other than aspirin (up to 100 mg/day)

- History of dermatologic keloid formation

- Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile
glaucoma, secondary glaucoma in the study eye

- History of following surgeries in the study eye:

- incisional refractive surgery (eg, radial keratotomy), other than astigmatic
keratotomy or limbal relaxing incisions

- corneal graft including partial grafts such as Descemet's stripping endothelial
keratoplasty and Descemet's membrane endothelial keratoplasty

- previous laser or incisional intraocular surgery that might interfere with the
outcome of this trial

- Previous glaucoma shunt implantation in the target quadrant in the study eye

- Active or history of chronic uveitis in the study eye

- Unable to discontinue contact lens wear in the study eye during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
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)
MelbourneNSW
Recruitment hospital [1] 0 0
Melbourne Eye Specialists - Fitzroy
Recruitment hospital [2] 0 0
St Vincent's private Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Marsden Eye Specialist - Parramatta
Recruitment hospital [4] 0 0
East Sydney Private Hospital - Woolloomooloo
Recruitment hospital [5] 0 0
Eye Surgery Associates - Melbourne
Recruitment hospital [6] 0 0
Vermont Private Hospital - Melbourne
Recruitment hospital [7] 0 0
Eye Associates - Sydney
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment postcode(s) [3] 0 0
2011 - Woolloomooloo
Recruitment postcode(s) [4] 0 0
3133 - Melbourne
Recruitment postcode(s) [5] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Canada
State/province [3] 0 0
Montreal
Country [4] 0 0
Hong Kong
State/province [4] 0 0
Kowloon
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore
Country [7] 0 0
Taiwan
State/province [7] 0 0
Hualien
Country [8] 0 0
Taiwan
State/province [8] 0 0
Kaohsiung
Country [9] 0 0
Taiwan
State/province [9] 0 0
Taipei
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Essex
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Surrey
Country [12] 0 0
United Kingdom
State/province [12] 0 0
West Sussex
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Edinburgh
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Frimley
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

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 safety and IOP-lowering effectiveness of XEN in patients with
Angle Closure Glaucoma.
Trial website
https://clinicaltrials.gov/show/NCT03362931
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eleonora Safyan
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 Trials 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/NCT03362931