GlaucomaXENPRONCT03852810
Satisfaction With XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma
An observational study of Glaucoma, run by Allergan at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- How many people
- 28 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 25 Feb 2019to 9 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For this study, approximately 150 eligible patients (75/group) will be enrolled in Canada, the UK, Germany, and Austria.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
- Patients who have received prior laser trabeculoplasty will be permitted to participate if all other inclusion/exclusion criteria are met.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Canada4 sites
Dalhousie University
Halifax, Nova Scotia, B3H 2Y9
Galen Eye Center
Kingston, Ontario, K7K 6Z6
Prism Eye Institute
Mississauga, Ontario, L5L1W8
Toronto Ophthalmic Research Innovation Centre, Inc
Toronto, Ontario, M5G 1Z5
Germany3 sites
Universitat Augenklinik
Mainz, 55131
Ludwig-Maximilians-Universität München
Munich, 80336
University of Tübingen
Tübingen
United Kingdom3 sites
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Royal Surrey County Hospital
Guildford
Southend University Hospital
Southend-on-Sea, SS0 0RY
About this study
Official title: Patient Reported Outcomes for XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma
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.
- Conditions
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Secondary outcomes (11)
To evaluate and compare the treatment satisfaction and expectations in patients receiving surgical intervention via XEN and trabeculectomy.
Patients treatment satisfaction and expectations will be measured using a study specific Glaucoma Surgery Satisfaction Survey.
Measured: 3 Months
To evaluate and compare work productivity in patients receiving surgical intervention via XEN and trabeculectomy.
Work productivity using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem v2.0 (WPAI:SHP)
The WPAI is a six question survey to quantitatively assess the amount of absenteeism, presenteeism, and daily activity impairment attributable to specific health problems. Participants will be asked about their employment status, the amount of hours they have missed due to their health problems, the amount of hours they have missed due to non-health problems, how many hours they worked, how much their health problems affected work productivity, and how much their health problems affected their regular daily activities for the recall period of one week
Measured: 3 Months
To evaluate and compare the visual acuity recovery time in patients receiving surgical intervention via XEN and trabeculectomy.
Visual acuity will be recorded from the patient chart and converted from the site-specific metric to EDTRS letter equivalents
Measured: 3 Months
To evaluate and compare the refractive change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.
Measured: 3 Months
To evaluate and compare the IOP (Intraocular Pressure) change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.
Measured: 3 Months
To evaluate and compare new onset ocular hypotensive medication use in patients receiving surgical intervention via XEN and trabeculectomy.
Measured: 3 Months
To present glaucoma procedure-related adverse events in patients receiving surgical intervention via XEN and trabeculectomy.
Measured: 3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by the mean number of physician office visits
Measured: 3 Months
To present post-operative medical management in patients receiving surgical intervention via XEN and trabeculectomy.
Measured: 3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by medication use
Measured: 3 Months
To present post-operative surgical management in patients receiving surgical intervention via XEN and trabeculectomy
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start25 Feb 2019
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanna Campbell, Ph.D, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852810
- Sponsor's protocol ID
- P-2016-6380
- Acronym
- XENPRO
- Status last verified
- Feb 2020
- First submitted
- 30 Jan 2019
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes for XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma
- ClinicalTrials.gov ID
- NCT03852810
- Acronym / sponsor ID
- XENPRO / P-2016-6380
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For this study, approximately 150 eligible patients (75/group) will be enrolled in Canada, the UK, Germany, and Austria.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate and compare the visual function and local eye symptoms in patients receiving surgical intervention via XEN (Xen gel stent) or trabeculectomy.
Time frame: 3 Months
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.
11 secondary outcomes
To evaluate and compare the treatment satisfaction and expectations in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate and compare work productivity in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate and compare the visual acuity recovery time in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate and compare the refractive change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate and compare the IOP (Intraocular Pressure) change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate and compare new onset ocular hypotensive medication use in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To present glaucoma procedure-related adverse events in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by the mean number of physician office visits
Time frame: 3 Months
To present post-operative medical management in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by medication use
Time frame: 3 Months
To present post-operative surgical management in patients receiving surgical intervention via XEN and trabeculectomy
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Campbell, Ph.D study director
Allergan
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Allergan at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate and compare the visual function and local eye symptoms in patients receiving surgical intervention via XEN (Xen gel stent) or trabeculectomy. (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.