NCT03852810

Brief Summary

This is a prospective, observational, non-interventional study of patients scheduled to receive surgical intervention either via XEN or trabeculectomy for open-angle glaucoma. The decision to treat patients with a particular surgical procedure will not be influenced by the study as the treatment decision will continue to be made by the patient and the clinician. There will be no study mandated visits or treatments.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2020

Completed
Last Updated

October 20, 2021

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

January 30, 2019

Last Update Submit

October 19, 2021

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • To evaluate and compare the visual function and local eye symptoms in patients receiving surgical intervention via XEN (Xen gel stent) or trabeculectomy.

    Visual function and local eye symptoms using the Glaucoma Symptom and Health Problem Chart (SHPC-18) SHPC-18 is an eighteen question survey to assess local eye and visual function symptoms caused by glaucoma or its treatments. The tool is comprised of 7 questions related to local eye symptoms, and 11 related to visual function problems. The 2-domain tool is a psychometrically validated measure of patient-reported, glaucoma-related symptoms that is responsive to treatment and discriminates the severity of glaucoma to better understand the influence of glaucoma symptoms on patients' daily life.

    3 Months

Secondary Outcomes (11)

  • To evaluate and compare the treatment satisfaction and expectations in patients receiving surgical intervention via XEN and trabeculectomy.

    3 Months

  • To evaluate and compare work productivity in patients receiving surgical intervention via XEN and trabeculectomy.

    3 Months

  • To evaluate and compare the visual acuity recovery time in patients receiving surgical intervention via XEN and trabeculectomy.

    3 Months

  • To evaluate and compare the refractive change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.

    3 Months

  • To evaluate and compare the IOP (Intraocular Pressure) change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.

    3 Months

  • +6 more secondary outcomes

Study Arms (2)

Receiving surgical intervention via XEN Gel Stent (XEN)

Patient Reported Outcomes (PRO) will be collected before and after this particular procedure

Receiving surgical intervention via trabeculectomy

Patient Reported Outcomes (PRO) will be collected before and after this particular procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For this study, approximately 150 eligible patients (75/group) will be enrolled in Canada, the UK, Germany, and Austria.

You may qualify if:

  • Diagnosed with OAG (Open Angle Glaucoma) and using at least 2 topical IOP-lowering medication classes in the study eye
  • Scheduled to receive surgical treatment with either XEN (Xen gel stent) or trabeculectomy in the study eye
  • Access to an electronic device with internet capabilities and an email address for completion of PROs (Patient Reported Outcomes)
  • Be willing and able to complete PROs (Patient Reported Outcomes) at the specified time points
  • Able to provide voluntary, informed consent to participate in this study

You may not qualify if:

  • Diagnosed with angle closure glaucoma in the study eye
  • Presence of a secondary glaucoma, pseudoexfoliation glaucoma, or pigmentary glaucoma
  • Presence of neovascular, uveitic, or angle recession glaucoma or any glaucoma associate with vascular disorders
  • Prior incisional glaucoma surgery, canal-based surgery, suprachoroidal space-based surgery (trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.) or a cilio-ablative procedure
  • Clinically significant inflammation or infection in the study eye within 30 days prior to the baseline visit (e.g. blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
  • History of corneal surgery, corneal opacities, or corneal disease
  • Prior intraocular surgery in either eye ≤ 3 months prior to study enrollment with the exception of uncomplicated cataract surgery in either eye ≥ 1 month prior to study enrollment
  • Anticipated ocular surgery in either eye within 6 months of baseline
  • Concomitant cataract surgery scheduled at the time of glaucoma procedure
  • The study eye is defined as the eye receiving surgical intervention with either XEN or trabeculectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Galen Eye Center

Kingston, Ontario, K7K 6Z6, Canada

Location

Prism Eye Institute

Mississauga, Ontario, L5L1W8, Canada

Location

Toronto Ophthalmic Research Innovation Centre, Inc

Toronto, Ontario, M5G 1Z5, Canada

Location

Universitat Augenklinik

Mainz, 55131, Germany

Location

Ludwig-Maximilians-Universität München

Munich, 80336, Germany

Location

University of Tübingen

Tübingen, Germany

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Royal Surrey County Hospital

Guildford, United Kingdom

Location

Southend University Hospital

Southend-on-Sea, SS0 0RY, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Joanna Campbell, Ph.D

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 25, 2019

Study Start

February 25, 2019

Primary Completion

December 9, 2020

Study Completion

December 9, 2020

Last Updated

October 20, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

More information

Locations

DE(3)CA(4)GB(3)