XEN GPS: XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the safety and efficacy of XEN-45 to trabeculectomy in participants with open angle glaucoma refractory to topical medical therapy.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to evaluate the ability of XEN-45 to reduce intraocular pressure (IOP) and reduce the amount of topical IOP-lowering medications in participants poorly controlled on topical therapy. The planned study duration is 12 months. Participants were to be screened for enrollment and eligible candidates were to be approached to ascertain interest in study participation. Eligible participants were to be randomized 2:1; resulting in approximately 95 eyes implanted with XEN-45 and 44 eyes received trabeculetomy by study end.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: XEN-45 Gel Stent Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). |
Device: XEN-45 Gel Stent
XEN-45 gel stent device implant
|
Active Comparator: Trabeculectomy Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Procedure: Trabeculectomy
Trabeculectomy surgery
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats [Baseline (Preoperative) to Month 12]
IOP is a measure of the fluid pressure inside the eye. In addition to achieving a 20% reduction of IOP from Baseline, the participants had to meet all of the following prespecified caveats at Month 12: no increase in the number of topical IOP-lowering medications compared to Baseline, no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.
Secondary Outcome Measures
- Mean IOP Over Time [Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12]
IOP is a measurement of the fluid pressure inside the eye.
- Change From Baseline in Mean IOP Over Time [Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12]
IOP is a measurement of the fluid pressure inside the eye.
- Mean Number of Topical IOP-Lowering Medications Over Time [Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12]
IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
- Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time [Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12]
IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
- Change From Baseline in Mean IOP at Month 12 [Baseline (Preoperative) and Month 12]
IOP is a measurement of the fluid pressure inside the eye.
- Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12 [Baseline (Preoperative) and Month 12]
IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
- Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg [Baseline (Preoperative) and Month 12]
IOP is a measurement of the fluid pressure inside the eye.
- Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg [Baseline (Preoperative) and Month 12]
Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
- Percentage of Participants Achieving Specific IOP Targets at Month 12 [Month 12]
IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg.
- Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 [Baseline (Preoperative) to Month 12]
IOP is a measurement of fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction.
- Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 [Baseline (Preoperative) and Month 12]
IOP is a measurement of fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg.
- Percentage of Participants With Needlings Performed [Up to Month 12]
Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye.
- Mean Number of Needlings Per Eye [Up to Month 12]
Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye.
- Percentage of Eyes Achieving at Least a 20% Reduction in IOP at Month 12 on the Same or Fewer Topical IOP-lowering Medications in Participants Who Had Needlings [Month 12]
IOP is a measurement of fluid pressure inside the eye. Topical IOP-lowering medication classes include: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
- Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings [Month 12]
Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
- Percentage of Participants With Antifibrotic Use During Needling [Up to Month 12]
Antifibrotic use included mitomycin-C (MMC) which was standardized for both groups and administered according to physician training and practice.
- Percentage of Participants Achieving Complete Success at Month 12 [Month 12]
Complete success was defined as IOP ≤18mm Hg, with 20% or greater IOP lowering from medicated Baseline, on no topical medications, and no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage.
- Percentage of Participants Achieving Qualified Success at Month 12 [Month12]
Qualified success was defined as IOP ≤18 mm Hg, with 20% or greater IOP lowering from medicated Baseline, taking topical medications at Baseline Qualifying Visit, no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage.
- Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye [Month 12]
IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12.
- Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes [Month 12]
IOP is a measurement of the fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12.
- Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use [Month 12]
Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice.
- Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration [Month 12]
Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The time of administration was classified into two categories as: Before Procedure and After Procedure.
- Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy [Month 12]
Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The mode of administration was classified into two categories as: Injection and Other. Other includes all other modes of administration apart from injection.
- Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy [Month 12]
Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The volume of administration measured in milliliters (mL) was classified into three categories as: 0.1, 0.2, and Other. Other includes all other volumes apart from 0.1 and 0.2.
- Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy [Month 12]
Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The concentration of administration measured in milligram per milliliter (mg/mL) was classified into three categories as: 0.2, 0.4, and Other. Other includes all other concentrations apart from 0.2 and 0.4.
- Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy [Month 12]
Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The absolute dose of administration measured in microgram per milliliter (µg/mL) was classified into two categories as: 40, and Other. Other includes all other concentrations apart from 40.
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses [Baseline and Day 1, Weeks 1 and 2, and Months 1, 3, 6, 9, and 12]
BCVA was performed using a Snellen eye chart with glasses, and the BCVA data collected in the visual acuity electronic case report form (eCRF) page was analyzed. The number of lines read correctly was assessed as the line change from baseline at each follow-up evaluation and were log transformed. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower and negative logMAR value indicating better visual acuity.
- Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale [Baseline (Preoperative) and postoperative Months 1, 3, 6, and 12]
Manifest Refraction - Mean Visual Acuity was performed using a Snellen eye chart with glasses. The line change from baseline at each follow-up evaluation in logarithm of the minimum angle of resolution (logMAR) was calculated. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
- Mean Surgically Induced Astigmatism - Autorefractor Reading [Month 12]
- Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading [Baseline (Preoperative) and Month 12]
- Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites [Baseline (Preoperative), Week 1, and Months 1 and 12]
- Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth [Baseline, Day 1 and Week 2]
- Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D [Baseline, Day 1 and Week 2]
The keratometric values for keratometry (K) measured in 2 meridians (i.e., flat keratometry [K1] and steep keratometry [K2]) along with Delta (D) were determined.
- Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites [Up to Month 12]
- Bleb Morphology - Slit Lamp Photography at Selected Sites [Up to Month 12]
- Percentage of Participants With Clinical Hypotony [Month 12]
Clinical hypotony was defined as vision reduction (2 lines or more) related to macular changes consistent with hypotony maculopathy (macular folds), optic disc edema, and/or serous choroidal detachments because of low IOP.
- Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment [Up to Month 12]
Eyes with IOP 6 mm Hg or less at any time point and relevant clinical assessment (vision reduction [2 lines or more] related to macular changes consistent with hypotony maculopathy [macular folds], optic disc edema, anterior chamber status, and/or serous choroidal detachments because of low IOP) of these eyes at those time points were assessed. Only data from study eyes are included. The worse eye was selected as the study eye if both eyes met the inclusion criteria. The worse eye was defined using the visual field MD at Baseline, with the worse eye having the most negative MD. In cases where the MD was the same in both eyes to two decimal places, the worse eye was defined as the eye with the higher IOP.
- Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) [Median follow-up of 366.0 days]
An adverse event(AE)is any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. Intraoperative AESIs included- Detached Descemet's membrane,iris damage,lens contact,vitreous bulge or loss,anterior chamber bleeding,retrobulbar hemorrhage,conjunctival perforation,conjunctival or scleral flap tearing,shallow anterior chamber with peripheral iridocorneal touch,flat anterior chamber with iridocorneal touch extending to the pupil,device malfunction identified prior to implantation,and choroidal hemorrhage of effusion. Only categories with at least one participant with event in the study eye are reported. The worse eye was selected as the study eye if both eyes met inclusion criteria. The worse eye was defined using visual field MD at Baseline, with the worse eye having the most negative MD. If MD was same in both eyes to two decimal places, the worse eye=eye with higher IOP.
- Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs) [Median follow-up of 366.0 days]
AE=any untoward medical occurrence in a clinical investigation participant administered drug;it does not necessarily have to have a causal relationship with the treatment. TEAE is an AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Postoperative AEs included but were not limited to: angle recession, anterior chamber changes, BCVA loss,bleb leak, blebitis, cataract, choroidal effusion, chronic pain, corneal edema, cyclodialysis, Dellen, device malfunction, endophthalmitis, fixed dilated pupil, hyphema, hypotony, implant issues, increase in corneal thickness/IOP, explant, iridodialysis, iritis, loss of eye, etc.Worse eye=eye if both eyes met inclusion criteria. Worse eye was defined using visual field MD at Baseline, with worse eye having the most negative MD. In cases where MD was the same in both eyes to two decimal places, worse eye was defined as eye with higher IOP.
- Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up [Baseline up to Month 12]
The categories = Worsening (<-2), No Change (≥-2 and ≥2), Improving (>2) and Missing were used for determining BCVA worst line change from Baseline. Only categories with at least one participant with event are reported.
- Pachymetry Based on Change From Baseline In Average Central Corneal Thickness [Baseline (Preoperative) and Month 12]
Pachymetry was measured as average central corneal thickness (microns/micrometer) change from Baseline.
- Change From Baseline in Visual Field Examinations Analyzed by Machine Type [Baseline and Month 12]
All visual field examination data were collected and reported as mean deviation by Humphrey machine.
- Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) [Median follow-up of 366.0 days]
AE=any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. An SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. ADEs and SADEs are AEs and SAEs that are caused by the device
- Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores [Baseline (Preoperative) to Month 6]
The SHPC-18 is an 18-item questionnaire that asks participants being treated for glaucoma questions about eye symptoms or problems they may experience. There are two domains: Local Eye Symptoms (7 items) subscale score 0 to 700 divided by 7 and Visual Function Problem (11 items) subscale score 0 to 1100 divided by 11. The scores of each subscale ranges from from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A frequency score was calculated by summing the individual response scores of each item, and ranges from 0 to 7 for Local Eye Symptom and from 0 to 11 for Visual Function. A total bothersome score for the SHPC-18 is calculated by summing all 18 items scores, resulting in a range from 0 to 1800, then dividing the sum by 18, to create a total bothersome score ranging from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A negative change from Baseline for all scales and subscales indicates improvement.
- PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine [Month 3]
Participants answered the question, "Since your glaucoma surgery, would you consider that you have resumed your usual activities and daily routine?" using the following categories: Not at all, Somewhat, Moderately so, Mostly, Completely.
- PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health [Baseline (Preoperative) and Month 12]
WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.
- PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health [Baseline (Preoperative) and Month 12]
WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Open-angle glaucoma where the intraocular pressure (IOP) is not controlled when using topical IOP-lowering glaucoma medication
-
Best-corrected baseline Snellen visual acuity of 20/100 or better
-
Visual field mean deviation no worse than -18.0 decibels (dB)
-
Medicated IOP ≥15 millimeter of mercury (mm Hg) and ≤44 mm Hg
-
Participants not anticipated to require any ocular surgery (e.g., cataract surgery) in either eye up to 3 months from the time of inclusion
-
Area of healthy, free, and mobile conjunctiva in the target area (superior bulbar conjunctiva)
-
Trabecular meshwork must be visible (with Shaffer angle grade ≥2 in the target quadrant)
-
Failed ab-interno canal or suprachoroidal micro invasive glaucoma surgery (MIGS) procedures (such as i-Stent, gonioscopy-assisted transluminal trabeculotomy [GATT], Ab-interno canaloplasty [ABiC], Kahook dual blade goniotomy, etc.) are allowed ≥3 months before enrollment. CyPass® Micro-Stents were not allowed.
Exclusion Criteria:
-
Participant has active neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
-
Participant has had prior ab externo incisional glaucoma surgery (such as trabeculectomy, viscocanalostomy, canaloplasty, tube shunts of any type, collagen implants, etc.), conjunctival filtering surgery, transscleral cycloablative procedures (such as cyclophotocoagulation, micro pulse cyclophotocoagulation, cryotherapy, ultrasound circular cyclocoagulation [UC3], etc.) or prior major conjunctival surgery (i.e., scleral buckle)
-
Clinically significant inflammation or infection within 30 days before the preoperative visit (e.g., blepharitis, conjunctivitis, severe ocular surface disease, keratitis, uveitis, herpes simplex infection)
-
Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target area
-
History of corneal surgery, corneal opacities, or corneal disease
-
Central corneal thickness ≤490 micrometer (μm) or ≥620μm
-
Vitreous present in the anterior chamber
-
Aphakic
-
Participant has had prior intraocular surgery in either eye within ≤3 months before the preoperative visit (including phacoemulsification)
-
History of complicated cataract surgery (e.g. with visual impairment, e.g. vitreous loss, anterior chamber intraocular lens [ACIOL], perhaps sutured intraocular lens [IOL] or scleral fixated IOL, prior cystoid macular edema [CME], etc.)
-
Presence of intraocular silicone oil
-
Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, geographic atrophy, or other ophthalmic disease or disorder that could confound study results or impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos, Axenfeld-Reiger, iridocorneal endothelial syndrome [ICE], etc.)
-
Known or suspected allergy or sensitivity to drugs required for the protocol (including anesthesia), or any of the device components (e.g., bovine or porcine products, or glutaraldehyde)
-
Pregnant or nursing women and those planning a pregnancy during the study period.
-
Participation in another drug or device clinical trial concluding within 30 days before the preoperative visit
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Vold Vision /ID# 233677 | Fayetteville | Arkansas | United States | 72704 |
2 | Retina Institute of California /ID# 233692 | Arcadia | California | United States | 91007 |
3 | Angeles Eye Institute /ID# 233632 | Culver City | California | United States | 90232 |
4 | Cha Medical Group Pc /Id# 233649 | Los Angeles | California | United States | 90027 |
5 | Grutzmacher Lewis and Sierra Inc. /ID# 233654 | Sacramento | California | United States | 95815 |
6 | University of Colorado Denver /ID# 233676 | Denver | Colorado | United States | 80291-0238 |
7 | Howard University Hospital /ID# 233615 | Washington | District of Columbia | United States | 20060 |
8 | Eye Surgery Associates /ID# 233638 | Hollywood | Florida | United States | 33020 |
9 | Specialty Retina Center /ID# 233628 | Weston | Florida | United States | 33326 |
10 | Georgia Eye Partners /ID# 233655 | Atlanta | Georgia | United States | 30342 |
11 | Coastal Research Associates /ID# 233575 | Roswell | Georgia | United States | 30076 |
12 | Tyrie Lee Jenkins MD Inc. /ID# 233674 | Honolulu | Hawaii | United States | 96814 |
13 | Illinois Eye Center /ID# 233631 | Peoria | Illinois | United States | 61615 |
14 | Stiles Eyecare Excellence /ID# 233583 | Overland Park | Kansas | United States | 66213 |
15 | Advanced Glaucoma Specialists /ID# 233690 | Reading | Massachusetts | United States | 01867 |
16 | Kellogg Eye Center University of Michigan health system /ID# 233651 | Ann Arbor | Michigan | United States | 48105 |
17 | Mayo Clinic Jacksonville /ID# 233634 | Saint Paul | Minnesota | United States | 55108 |
18 | Washington University in St. Louis /ID# 233599 | Saint Louis | Missouri | United States | 63110 |
19 | Glaucoma associates/consultants of the capital region /ID# 233695 | Slingerlands | New York | United States | 12159 |
20 | Carolina Eye Associates /ID# 233656 | Southern Pines | North Carolina | United States | 28387 |
21 | Eye Care Associates Inc /ID# 233636 | Youngstown | Ohio | United States | 44502 |
22 | Dean McGee Eye Institute /ID# 233595 | Oklahoma City | Oklahoma | United States | 73104 |
23 | Ludwick Eye Center /ID# 233691 | Chambersburg | Pennsylvania | United States | 17201 |
24 | Kremer Eye Center /Id# 233642 | King Of Prussia | Pennsylvania | United States | 19406 |
25 | Wills Eye Institute /ID# 233645 | Philadelphia | Pennsylvania | United States | 19107 |
26 | university of Pittsburgh /ID# 233622 | Pittsburgh | Pennsylvania | United States | 15213 |
27 | Carolinas Centers for Sight,PC /ID# 233606 | Florence | South Carolina | United States | 29501 |
28 | Nashville Vision Associates /ID# 233644 | Nashville | Tennessee | United States | 37205 |
29 | Glaucoma Associates of Texas /ID# 233587 | Dallas | Texas | United States | 75231 |
30 | El Paso Eye Surgeons, P.A. /ID# 233584 | El Paso | Texas | United States | 79902 |
31 | Houston Eye Associates /ID# 233621 | Houston | Texas | United States | 77025 |
32 | Baylor College of Medicine - Baylor Medical Center /ID# 233612 | Houston | Texas | United States | 77030-3411 |
33 | Vistar Eye Center /ID# 233652 | Roanoke | Virginia | United States | 24011 |
34 | SSM Health Dean Medical Group /ID# 233624 | Madison | Wisconsin | United States | 53715 |
35 | The Eye Centers of Racine and Kenosha LTD /ID# 233657 | Racine | Wisconsin | United States | 53405 |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: ALLERGAN INC., Allergan
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- CMO-US-EYE-0600
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | One eye, the worse eye, from each participant was selected as the study eye. The worse eye was defined using the visual field mean deviation (MD) at baseline, with the worse eye having the most negative MD. In the case where the MD was the same in both eyes, to two decimal places, the worse eye is defined as the eye with the higher IOP. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Period Title: Overall Study | ||
STARTED | 107 | 51 |
Intent-to-Treat (ITT) Population | 95 | 44 |
Safety Population | 95 | 44 |
COMPLETED | 77 | 38 |
NOT COMPLETED | 30 | 13 |
Baseline Characteristics
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy | Total |
---|---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). | Total of all reporting groups |
Overall Participants | 95 | 44 | 139 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
69.5
(9.64)
|
69.4
(9.72)
|
69.5
(9.63)
|
Sex: Female, Male (Count of Participants) | |||
Female |
41
43.2%
|
19
43.2%
|
60
43.2%
|
Male |
54
56.8%
|
25
56.8%
|
79
56.8%
|
Race/Ethnicity, Customized (Count of Participants) | |||
American Indian or Alaska Native |
18
18.9%
|
10
22.7%
|
28
20.1%
|
Asian |
2
2.1%
|
0
0%
|
2
1.4%
|
Black or African American |
14
14.7%
|
8
18.2%
|
22
15.8%
|
White or Caucasian |
61
64.2%
|
26
59.1%
|
87
62.6%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Ethnicity |
0
0%
|
||
Study Eye Intraocular Pressure (IOP) (millimetre of mercury (mm Hg)) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [millimetre of mercury (mm Hg)] |
23.13
(5.817)
|
22.56
(5.653)
|
22.95
(5.751)
|
Outcome Measures
Title | Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats |
---|---|
Description | IOP is a measure of the fluid pressure inside the eye. In addition to achieving a 20% reduction of IOP from Baseline, the participants had to meet all of the following prespecified caveats at Month 12: no increase in the number of topical IOP-lowering medications compared to Baseline, no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention. |
Time Frame | Baseline (Preoperative) to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Number [percentage of participants] |
62.1
65.4%
|
68.2
155%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | By assuming the margin of non-inferiority at 24%, the null hypothesis for this non-inferiority testing was to be set up as XEN implanted group (P1)-Trabeculectomy group (P2) ≤-0.24 versus the alternative hypothesis as P1-P2 >-0.24. Equivalently, non-inferiority of P1 to P2 was to be declared if the lower limit of the 2-sided confidence interval (CI) of the difference of the above endpoint between the two treatment groups computed using normal approximation was found to be greater than -24%. | |
Statistical Test of Hypothesis | p-Value | 0.487 |
Comments | ||
Method | Chi-squared | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -6.1 | |
Confidence Interval |
(2-Sided) 95% -22.9 to 10.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Mean IOP Over Time |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. |
Time Frame | Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the specified timepoints. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Day 1 |
9.25
(4.710)
|
15.00
(13.025)
|
Week 1 |
11.27
(6.864)
|
11.48
(7.323)
|
Week 2 |
13.64
(8.363)
|
11.53
(5.503)
|
Month 1 |
13.72
(6.315)
|
11.45
(5.645)
|
Month 3 |
16.46
(7.407)
|
11.59
(4.672)
|
Month 6 |
14.86
(4.228)
|
11.72
(5.242)
|
Month 9 |
14.57
(4.221)
|
11.02
(3.535)
|
Month 12 |
14.43
(4.060)
|
11.83
(3.525)
|
Title | Change From Baseline in Mean IOP Over Time |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. |
Time Frame | Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the specified timepoints. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Change From Baseline at Day 1 |
-13.63
(0.645)
|
-7.82
(0.958)
|
Change From Baseline at Week 1 |
-11.56
(0.660)
|
-11.34
(0.958)
|
Change From Baseline at Week 2 |
-9.26
(0.657)
|
-11.29
(0.958)
|
Change From Baseline at Month 1 |
-9.15
(0.648)
|
-11.37
(0.958)
|
Change From Baseline at Month 3 |
-6.35
(0.663)
|
-11.09
(0.977)
|
Change From Baseline at Month 6 |
-7.94
(0.690)
|
-10.95
(0.978)
|
Change From Baseline at Month 9 |
-8.19
(0.690)
|
-11.72
(0.978)
|
Change From Baseline at Month 12 |
-8.25
(0.701)
|
-11.02
(1.009)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change From Baseline in Mean IOP Over Time: Day 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | Mixed Model for Repeated Measures (MMRM) model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -5.81 | |
Confidence Interval |
(2-Sided) 95% -8.074 to -3.538 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.155 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change From Baseline in Mean IOP Over Time: Week 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.851 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -0.22 | |
Confidence Interval |
(2-Sided) 95% -2.503 to 2.066 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.163 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change From Baseline in Mean IOP Over Time: Week 2 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.081 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 2.03 | |
Confidence Interval |
(2-Sided) 95% -0.253 to 4.309 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.162 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change From Baseline in Mean IOP Over Time: Month 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.056 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 2.21 | |
Confidence Interval |
(2-Sided) 95% -0.059 to 4.484 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.157 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change From Baseline in Mean IOP Over Time: Month 3 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 4.74 | |
Confidence Interval |
(2-Sided) 95% 2.416 to 7.054 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.181 |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change From Baseline in Mean IOP Over Time: Month 6 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.012 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 3.01 | |
Confidence Interval |
(2-Sided) 95% 0.657 to 5.358 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.197 |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change From Baseline in Mean IOP Over Time: Month 9 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 3.53 | |
Confidence Interval |
(2-Sided) 95% 1.182 to 5.883 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.197 |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change From Baseline in Mean IOP Over Time: Month 12 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.024 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 2.77 | |
Confidence Interval |
(2-Sided) 95% 0.358 to 5.183 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.229 |
|
Estimation Comments |
Title | Mean Number of Topical IOP-Lowering Medications Over Time |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
Time Frame | Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the specified timepoints. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Day 1 |
0.2
(0.51)
|
0.3
(0.53)
|
Week 1 |
0.3
(0.77)
|
0.3
(0.73)
|
Week 2 |
0.3
(0.64)
|
0.2
(0.53)
|
Month 1 |
0.3
(0.75)
|
0.1
(0.52)
|
Month 3 |
0.5
(0.89)
|
0.1
(0.26)
|
Month 6 |
0.6
(0.96)
|
0.2
(0.58)
|
Month 9 |
0.6
(1.09)
|
0.2
(0.49)
|
Month 12 |
0.6
(0.95)
|
0.3
(0.50)
|
Title | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
Time Frame | Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the specified timepoints. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Change From Baseline at Day 1 |
-2.1
(0.08)
|
-2.0
(0.11)
|
Change From Baseline at Week 1 |
-2.0
(0.08)
|
-2.0
(0.11)
|
Change From Baseline at Week 2 |
-2.0
(0.08)
|
-2.1
(0.11)
|
Change From Baseline at Month 1 |
-2.0
(0.08)
|
-2.1
(0.11)
|
Change From Baseline at Month 3 |
-1.8
(0.08)
|
-2.2
(0.11)
|
Change From Baseline at Month 6 |
-1.7
(0.08)
|
-2.0
(0.11)
|
Change From Baseline at Month 9 |
-1.7
(0.08)
|
-2.0
(0.11)
|
Change From Baseline at Month 12 |
-1.7
(0.08)
|
-2.0
(0.11)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent |
---|---|---|
Comments | Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Day 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.505 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -0.36 to 0.18 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.949 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -0.28 to 0.26 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 2 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.581 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -0.19 to 0.34 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.302 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -0.13 to 0.41 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 3 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.005 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% 0.12 to 0.66 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 6 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.026 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% 0.04 to 0.59 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 9 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.010 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% 0.09 to 0.64 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 12 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.052 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% 0.00 to 0.54 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Title | Change From Baseline in Mean IOP at Month 12 |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. |
Time Frame | Baseline (Preoperative) and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery Overall number analyzed are the number of participants with data available for analyses. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 78 | 38 |
Least Squares Mean (Standard Error) [mm Hg] |
-8.25
(0.701)
|
-11.02
(1.009)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.024 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 2.77 | |
Confidence Interval |
(2-Sided) 95% 0.358 to 5.183 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.229 |
|
Estimation Comments |
Title | Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12 |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
Time Frame | Baseline (Preoperative) and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with data available for analyses. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 87 | 41 |
Least Squares Mean (Standard Error) [medications] |
-1.7
(0.08)
|
-2.0
(0.11)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.052 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% 0.00 to 0.54 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Title | Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. |
Time Frame | Baseline (Preoperative) and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with Baseline IOP ≤18 mmHg in the ITT population and data available for analyses. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 18 | 9 |
Least Squares Mean (Standard Error) [mm Hg] |
-2.83
(1.281)
|
-4.61
(1.801)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.421 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis. | |
Method | Mixed model repeated measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 1.79 | |
Confidence Interval |
(2-Sided) 95% -2.579 to 6.151 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.214 |
|
Estimation Comments |
Title | Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg |
---|---|
Description | Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
Time Frame | Baseline (Preoperative) and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with Baseline IOP ≤18 mmHg in the ITT population and data available for analyses. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 20 | 11 |
Least Squares Mean (Standard Error) [medications] |
-1.8
(0.15)
|
-2.1
(0.20)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.180 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis. | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -0.16 to 0.84 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.25 |
|
Estimation Comments |
Title | Percentage of Participants Achieving Specific IOP Targets at Month 12 |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Measure eyes | 95 | 44 |
IOP Value of ≤18 mm Hg |
68.4
72%
|
84.1
191.1%
|
IOP Value of ≤17 mm Hg |
64.2
67.6%
|
79.5
180.7%
|
IOP Value of ≤16 mm Hg |
62.1
65.4%
|
79.5
180.7%
|
IOP Value of ≤15 mm Hg |
55.8
58.7%
|
72.7
165.2%
|
IOP Value of ≤14 mm Hg |
50.5
53.2%
|
63.6
144.5%
|
IOP Value of ≤13 mm Hg |
36.8
38.7%
|
56.8
129.1%
|
IOP Value of ≤12 mm Hg |
30.5
32.1%
|
43.2
98.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤18 mmHg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.064 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -15.7 | |
Confidence Interval |
(2-Sided) 95% -33.0 to 2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤17 mmHg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.078 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -15.3 | |
Confidence Interval |
(2-Sided) 95% -32.7 to 2.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤16 mmHg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.051 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -17.4 | |
Confidence Interval |
(2-Sided) 95% -34.7 to 0.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤15 mmHg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.064 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -16.9 | |
Confidence Interval |
(2-Sided) 95% -34.1 to 1.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤14 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.200 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -13.1 | |
Confidence Interval |
(2-Sided) 95% -30.5 to 4.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤13 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.042 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -20.0 | |
Confidence Interval |
(2-Sided) 95% -37.1 to -2.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤12 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.180 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -12.7 | |
Confidence Interval |
(2-Sided) 95% -30.1 to 5.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 |
---|---|
Description | IOP is a measurement of fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction. |
Time Frame | Baseline (Preoperative) to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Measure eyes | 95 | 44 |
≥25% IOP Reduction |
60.0
63.2%
|
63.6
144.5%
|
≥30% IOP Reduction |
48.4
50.9%
|
61.4
139.5%
|
≥35% IOP Reduction |
41.1
43.3%
|
61.4
139.5%
|
≥40% IOP Reduction |
35.8
37.7%
|
54.5
123.9%
|
≥45% IOP Reduction |
25.3
26.6%
|
43.2
98.2%
|
≥50% IOP Reduction |
22.1
23.3%
|
43.2
98.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥25% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.712 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -3.6 | |
Confidence Interval |
(2-Sided) 95% -21.3 to 14.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥30% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.201 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -12.9 | |
Confidence Interval |
(2-Sided) 95% -30.3 to 5.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥35% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.030 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -20.3 | |
Confidence Interval |
(2-Sided) 95% -37.3 to -2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥40% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.043 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -18.8 | |
Confidence Interval |
(2-Sided) 95% -36.0 to -0.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥45% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.048 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -17.9 | |
Confidence Interval |
(2-Sided) 95% -35.1 to 0.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥50% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.015 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -21.1 | |
Confidence Interval |
(2-Sided) 95% -38.1 to -3.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 |
---|---|
Description | IOP is a measurement of fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg. |
Time Frame | Baseline (Preoperative) and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
IOP Target ≤18 mm Hg |
61.1
64.3%
|
72.7
165.2%
|
IOP Target ≤17 mm Hg |
58.9
62%
|
70.5
160.2%
|
IOP Target ≤16 mm Hg |
56.8
59.8%
|
70.5
160.2%
|
IOP Target ≤15 mm Hg |
55.8
58.7%
|
70.5
160.2%
|
IOP Target ≤14 mm Hg |
50.5
53.2%
|
61.4
139.5%
|
IOP Target ≤13 mm Hg |
36.8
38.7%
|
54.5
123.9%
|
IOP Target ≤12 mm Hg |
30.5
32.1%
|
43.2
98.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤18 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.252 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -11.7 | |
Confidence Interval |
(2-Sided) 95% -29.0 to 6.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤17 mmHg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.258 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -11.5 | |
Confidence Interval |
(2-Sided) 95% -28.9 to 6.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤16 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.139 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -13.6 | |
Confidence Interval |
(2-Sided) 95% -30.9 to 4.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤15 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.136 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -14.7 | |
Confidence Interval |
(2-Sided) 95% -32.0 to 3.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤14 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference.%. | |
Statistical Test of Hypothesis | p-Value | 0.274 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -10.8 | |
Confidence Interval |
(2-Sided) 95% -28.2 to 7.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤13 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.065 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -17.7 | |
Confidence Interval |
(2-Sided) 95% -35.0 to 0.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤12 mmHg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.180 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -12.7 | |
Confidence Interval |
(2-Sided) 95% -30.1 to 5.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants With Needlings Performed |
---|---|
Description | Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye. |
Time Frame | Up to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Number [percentage of participants] |
23.2
24.4%
|
18.2
41.4%
|
Title | Mean Number of Needlings Per Eye |
---|---|
Description | Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye. |
Time Frame | Up to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants who had needlings with evaluable assessment at a specific timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 22 | 8 |
Mean (Standard Deviation) [needlings] |
1.7
(1.03)
|
1.4
(0.74)
|
Title | Percentage of Eyes Achieving at Least a 20% Reduction in IOP at Month 12 on the Same or Fewer Topical IOP-lowering Medications in Participants Who Had Needlings |
---|---|
Description | IOP is a measurement of fluid pressure inside the eye. Topical IOP-lowering medication classes include: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants who had needlings with evaluable assessment. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 16 | 7 |
Measure Eyes | 16 | 7 |
Number [percentage of eyes] |
87.5
|
85.7
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 1.000 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 1.8 | |
Confidence Interval |
(2-Sided) 95% -41.6 to 44.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings |
---|---|
Description | Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants who had needlings with evaluable assessment. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 21 | 8 |
Measure Eyes | 21 | 8 |
Number [percentage of eyes] |
42.9
|
75.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.215 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -32.1 | |
Confidence Interval |
(2-Sided) 95% -66.8 to 10.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants With Antifibrotic Use During Needling |
---|---|
Description | Antifibrotic use included mitomycin-C (MMC) which was standardized for both groups and administered according to physician training and practice. |
Time Frame | Up to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Number [percentage of participants] |
16.8
17.7%
|
15.9
36.1%
|
Title | Percentage of Participants Achieving Complete Success at Month 12 |
---|---|
Description | Complete success was defined as IOP ≤18mm Hg, with 20% or greater IOP lowering from medicated Baseline, on no topical medications, and no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. This outcome measure was analyzed among the participants without topical medication at Baseline Qualifying Visit. Number analyzed is the number of participants with data available for analysis at specific timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Number [percentage of participants] |
44.2
46.5%
|
59.1
134.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.144 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -14.9 | |
Confidence Interval |
(2-Sided) 95% -32.2 to 3.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants Achieving Qualified Success at Month 12 |
---|---|
Description | Qualified success was defined as IOP ≤18 mm Hg, with 20% or greater IOP lowering from medicated Baseline, taking topical medications at Baseline Qualifying Visit, no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage. |
Time Frame | Month12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. This outcome measure was analyzed among the participants with topical medication at Baseline Qualifying Visit. Number analyzed is the number of participants with data available for analysis at specific timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Number [percentage of participants] |
62.1
65.4%
|
72.7
165.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.254 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -10.6 | |
Confidence Interval |
(2-Sided) 95% -28.0 to 7.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants who were medication free at Month 12 with evaluable assessment. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 59 | 31 |
IOP Target ≤18 mm Hg |
79.7
83.9%
|
87.1
198%
|
IOP Target ≤17 mm Hg |
74.6
78.5%
|
87.1
198%
|
IOP Target ≤16 mm Hg |
71.2
74.9%
|
87.1
198%
|
IOP Target ≤15 mm Hg |
64.4
67.8%
|
83.9
190.7%
|
IOP Target ≤14 mm Hg |
59.3
62.4%
|
80.6
183.2%
|
IOP Target ≤13 mm Hg |
47.5
50%
|
71.0
161.4%
|
IOP Target ≤12 mm Hg |
37.3
39.3%
|
58.1
132%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤18 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.563 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -7.4 | |
Confidence Interval |
(2-Sided) 95% -28.6 to 14.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤17 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.188 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -12.5 | |
Confidence Interval |
(2-Sided) 95% -33.5 to 9.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤16 mmHg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.118 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -15.9 | |
Confidence Interval |
(2-Sided) 95% -36.7 to 5.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤15 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.085 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -19.5 | |
Confidence Interval |
(2-Sided) 95% -40.2 to 2.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤14 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.059 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -21.3 | |
Confidence Interval |
(2-Sided) 95% -42.0 to 0.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤13 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.045 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -23.5 | |
Confidence Interval |
(2-Sided) 95% -43.9 to -1.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤12 mm Hg | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.076 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -20.8 | |
Confidence Interval |
(2-Sided) 95% -41.3 to 1.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes |
---|---|
Description | IOP is a measurement of the fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with data available for analyses. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 59 | 31 |
≥25% IOP Reduction |
67.8
71.4%
|
77.4
175.9%
|
≥30% IOP Reduction |
57.6
60.6%
|
77.4
175.9%
|
≥35% IOP Reduction |
50.8
53.5%
|
77.4
175.9%
|
≥40% IOP Reduction |
44.1
46.4%
|
67.7
153.9%
|
≥45% IOP Reduction |
30.5
32.1%
|
58.1
132%
|
≥50% IOP Reduction |
27.1
28.5%
|
58.1
132%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥ 25% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.464 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -9.6 | |
Confidence Interval |
(2-Sided) 95% -31.0 to 12.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥30% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.069 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -19.8 | |
Confidence Interval |
(2-Sided) 95% -40.6 to 2.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥35% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.023 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -26.6 | |
Confidence Interval |
(2-Sided) 95% -46.9 to -4.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥40% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.046 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -23.7 | |
Confidence Interval |
(2-Sided) 95% -43.9 to -1.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥45% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.014 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -27.6 | |
Confidence Interval |
(2-Sided) 95% -47.6 to -5.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥50% IOP Reduction | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.006 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | -30.9 | |
Confidence Interval |
(2-Sided) 95% -50.8 to -9.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use |
---|---|
Description | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Number [percentage of participants] |
98.9
104.1%
|
97.7
222%
|
Title | Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration |
---|---|
Description | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The time of administration was classified into two categories as: Before Procedure and After Procedure. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Before Procedure |
37.9
39.9%
|
56.8
129.1%
|
After Procedure |
61.1
64.3%
|
40.9
93%
|
Title | Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy |
---|---|
Description | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The mode of administration was classified into two categories as: Injection and Other. Other includes all other modes of administration apart from injection. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Injection |
98.9
104.1%
|
84.1
191.1%
|
Other |
0
0%
|
13.6
30.9%
|
Title | Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy |
---|---|
Description | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The volume of administration measured in milliliters (mL) was classified into three categories as: 0.1, 0.2, and Other. Other includes all other volumes apart from 0.1 and 0.2. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
0.1 |
50.5
53.2%
|
34.1
77.5%
|
0.2 |
47.4
49.9%
|
56.8
129.1%
|
Other |
1.1
1.2%
|
2.3
5.2%
|
Title | Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy |
---|---|
Description | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The concentration of administration measured in milligram per milliliter (mg/mL) was classified into three categories as: 0.2, 0.4, and Other. Other includes all other concentrations apart from 0.2 and 0.4. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
0.2 |
34.7
36.5%
|
36.4
82.7%
|
0.4 |
64.2
67.6%
|
56.8
129.1%
|
Other |
0
0%
|
0
0%
|
Title | Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy |
---|---|
Description | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The absolute dose of administration measured in microgram per milliliter (µg/mL) was classified into two categories as: 40, and Other. Other includes all other concentrations apart from 40. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
40 |
97.9
103.1%
|
93.2
211.8%
|
Other |
1.1
1.2%
|
0
0%
|
Title | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses |
---|---|
Description | BCVA was performed using a Snellen eye chart with glasses, and the BCVA data collected in the visual acuity electronic case report form (eCRF) page was analyzed. The number of lines read correctly was assessed as the line change from baseline at each follow-up evaluation and were log transformed. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower and negative logMAR value indicating better visual acuity. |
Time Frame | Baseline and Day 1, Weeks 1 and 2, and Months 1, 3, 6, 9, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the given timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Change From Baseline at Day 1 |
-1.4
(0.20)
|
-2.5
(0.29)
|
Change From Baseline at Week 1 |
-1.2
(0.20)
|
-2.4
(0.29)
|
Change From Baseline at Week 2 |
-1.1
(0.20)
|
-1.6
(0.29)
|
Change From Baseline at Month 1 |
-0.6
(0.20)
|
-1.1
(0.30)
|
Change From Baseline at Month 3 |
-0.4
(0.20)
|
-0.5
(0.30)
|
Change From Baseline at Month 6 |
-0.4
(0.21)
|
-0.4
(0.30)
|
Change From Baseline at Month 9 |
-0.4
(0.21)
|
-1.0
(0.30)
|
Change From Baseline at Month 12 |
-0.1
(0.21)
|
-0.8
(0.31)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses: Day 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.004 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis | |
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 1.0 | |
Confidence Interval |
(2-Sided) 95% 0.33 to 1.72 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.35 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% 0.47 to 1.88 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 2 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.162 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -0.20 to 1.20 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.185 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -0.23 to 1.19 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 3 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.846 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -0.64 to 0.79 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 6 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.965 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -0.73 to 0.70 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 9 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.096 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -0.11 to 1.33 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.37 |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 12 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.063 |
Comments | MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis | |
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.7 | |
Confidence Interval |
(2-Sided) 95% -0.04 to 1.43 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.37 |
|
Estimation Comments |
Title | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale |
---|---|
Description | Manifest Refraction - Mean Visual Acuity was performed using a Snellen eye chart with glasses. The line change from baseline at each follow-up evaluation in logarithm of the minimum angle of resolution (logMAR) was calculated. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. |
Time Frame | Baseline (Preoperative) and postoperative Months 1, 3, 6, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the given timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Change From Baseline at Month 1 |
0.05
(0.015)
|
0.10
(0.022)
|
Change From Baseline at Month 3 |
0.04
(0.016)
|
0.05
(0.022)
|
Change From Baseline at Month 6 |
0.04
(0.016)
|
0.04
(0.022)
|
Change From Baseline at Month 12 |
0.01
(0.016)
|
0.07
(0.022)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.048 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.05 | |
Confidence Interval |
(2-Sided) 95% -0.105 to 0.000 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.027 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 3 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.742 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.01 | |
Confidence Interval |
(2-Sided) 95% -0.062 to 0.045 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.027 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 6 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.925 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.00 | |
Confidence Interval |
(2-Sided) 95% -0.056 to 0.051 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.027 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 12 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.021 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.06 | |
Confidence Interval |
(2-Sided) 95% -0.118 to -0.010 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.028 |
|
Estimation Comments |
Title | Mean Surgically Induced Astigmatism - Autorefractor Reading |
---|---|
Description | |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
No data is reported due to inaccuracy of the results (autorefractor reading errors). |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 0 | 0 |
Title | Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading |
---|---|
Description | |
Time Frame | Baseline (Preoperative) and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
No data is reported due to inaccuracy of the results (autorefractor reading errors). |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 0 | 0 |
Title | Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites |
---|---|
Description | |
Time Frame | Baseline (Preoperative), Week 1, and Months 1 and 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analyses at Baseline. Number Analyzed is the number of participants with data available for analyses at Baseline and the given timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 23 | 12 |
Change From Baseline at Week 1 |
0.057
(0.1861)
|
0.619
(0.2639)
|
Change From Baseline at Month 1 |
0.187
(0.1931)
|
0.326
(0.2741)
|
Change From Baseline at Month 12 |
0.106
(0.1976)
|
0.558
(0.2860)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Week 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.087 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.562 | |
Confidence Interval |
(2-Sided) 95% -1.2082 to 0.0851 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.3231 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.682 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.138 | |
Confidence Interval |
(2-Sided) 95% -0.8090 to 0.5324 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.3355 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 12 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.199 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.452 | |
Confidence Interval |
(2-Sided) 95% -1.1483 to 0.2434 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.3484 |
|
Estimation Comments |
Title | Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth |
---|---|
Description | |
Time Frame | Baseline, Day 1 and Week 2 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analyses at Baseline. Number Analyzed is the number of participants with data available for analyses at Baseline and the given timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 21 | 10 |
Change from Baseline at Day 1 |
-0.183
(0.1295)
|
-0.182
(0.1553)
|
Change from Baseline at Week 2 |
-0.206
(0.1195)
|
-0.427
(0.1732)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change in Optical Biometry - Anterior Chamber Depth at Day 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.997 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.001 | |
Confidence Interval |
(2-Sided) 95% -0.4103 to 0.4086 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.2026 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change in Optical Biometry - Anterior Chamber Depth at Week 2 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.302 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.222 | |
Confidence Interval |
(2-Sided) 95% -0.2068 to 0.6506 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.2124 |
|
Estimation Comments |
Title | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D |
---|---|
Description | The keratometric values for keratometry (K) measured in 2 meridians (i.e., flat keratometry [K1] and steep keratometry [K2]) along with Delta (D) were determined. |
Time Frame | Baseline, Day 1 and Week 2 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analyses at Baseline. Number Analyzed is the number of participants with data available for analyses at Baseline and the given timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 21 | 12 |
K1, Change from Baseline at Day 1 |
-0.103
(0.2195)
|
-0.446
(0.2512)
|
K1, Change from Baseline at Week 2 |
0.156
(0.1973)
|
-0.105
(0.2618)
|
K2, Change from Baseline at Day 1 |
0.373
(0.2947)
|
0.783
(0.3342)
|
K2, Change from Baseline at Week 2 |
0.152
(0.2626)
|
0.640
(0.3499)
|
Delta D, Change from Baseline at Day 1 |
0.514
(0.2967)
|
1.279
(0.3372)
|
Delta D, Change from Baseline at Week 2 |
0.087
(0.2636)
|
0.664
(0.3527)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change in from Baseline Optical Biometry - K1 at Day 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.309 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.343 | |
Confidence Interval |
(2-Sided) 95% -0.3289 to 1.0154 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.3336 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change in from Baseline Optical Biometry - K1 at Week 2 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.430 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | 0.261 | |
Confidence Interval |
(2-Sided) 95% -0.3993 to 0.9220 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.3278 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change in from Baseline Optical Biometry - K2 at Day 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.363 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.409 | |
Confidence Interval |
(2-Sided) 95% -1.3071 to 0.4882 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.4457 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change in from Baseline Optical Biometry - K2 at Week 2 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.272 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.488 | |
Confidence Interval |
(2-Sided) 95% -1.3709 to 0.3954 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.4383 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change in from Baseline Optical Biometry - Delta D at Day 1 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.096 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.765 | |
Confidence Interval |
(2-Sided) 95% -1.6722 to 0.1420 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.4502 |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | Mean Change in from Baseline Optical Biometry - Delta D at Week 2 | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.198 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.576 | |
Confidence Interval |
(2-Sided) 95% -1.4655 to 0.3129 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.4411 |
|
Estimation Comments |
Title | Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites |
---|---|
Description | |
Time Frame | Up to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
No tabular data was collected. Photographs were taken at select sites to be used for publication purposes. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 0 | 0 |
Title | Bleb Morphology - Slit Lamp Photography at Selected Sites |
---|---|
Description | |
Time Frame | Up to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
No tabular data was collected. Photographs were taken at select sites to be used for publication purposes. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 0 | 0 |
Title | Percentage of Participants With Clinical Hypotony |
---|---|
Description | Clinical hypotony was defined as vision reduction (2 lines or more) related to macular changes consistent with hypotony maculopathy (macular folds), optic disc edema, and/or serous choroidal detachments because of low IOP. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Number [percentage of participants] |
23.2
24.4%
|
50.0
113.6%
|
Title | Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment |
---|---|
Description | Eyes with IOP 6 mm Hg or less at any time point and relevant clinical assessment (vision reduction [2 lines or more] related to macular changes consistent with hypotony maculopathy [macular folds], optic disc edema, anterior chamber status, and/or serous choroidal detachments because of low IOP) of these eyes at those time points were assessed. Only data from study eyes are included. The worse eye was selected as the study eye if both eyes met the inclusion criteria. The worse eye was defined using the visual field MD at Baseline, with the worse eye having the most negative MD. In cases where the MD was the same in both eyes to two decimal places, the worse eye was defined as the eye with the higher IOP. |
Time Frame | Up to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants/eyes that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Measure eyes | 95 | 44 |
Number [percentage of eyes] |
13.7
|
29.5
|
Title | Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) |
---|---|
Description | An adverse event(AE)is any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. Intraoperative AESIs included- Detached Descemet's membrane,iris damage,lens contact,vitreous bulge or loss,anterior chamber bleeding,retrobulbar hemorrhage,conjunctival perforation,conjunctival or scleral flap tearing,shallow anterior chamber with peripheral iridocorneal touch,flat anterior chamber with iridocorneal touch extending to the pupil,device malfunction identified prior to implantation,and choroidal hemorrhage of effusion. Only categories with at least one participant with event in the study eye are reported. The worse eye was selected as the study eye if both eyes met inclusion criteria. The worse eye was defined using visual field MD at Baseline, with the worse eye having the most negative MD. If MD was same in both eyes to two decimal places, the worse eye=eye with higher IOP. |
Time Frame | Median follow-up of 366.0 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Anterior Chamber Bleeding |
1.1
1.2%
|
4.5
10.2%
|
Other |
1.1
1.2%
|
2.3
5.2%
|
Conjunctival Buttonhole |
0.0
0%
|
2.3
5.2%
|
Iris Damage |
0.0
0%
|
2.3
5.2%
|
Title | Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs) |
---|---|
Description | AE=any untoward medical occurrence in a clinical investigation participant administered drug;it does not necessarily have to have a causal relationship with the treatment. TEAE is an AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Postoperative AEs included but were not limited to: angle recession, anterior chamber changes, BCVA loss,bleb leak, blebitis, cataract, choroidal effusion, chronic pain, corneal edema, cyclodialysis, Dellen, device malfunction, endophthalmitis, fixed dilated pupil, hyphema, hypotony, implant issues, increase in corneal thickness/IOP, explant, iridodialysis, iritis, loss of eye, etc.Worse eye=eye if both eyes met inclusion criteria. Worse eye was defined using visual field MD at Baseline, with worse eye having the most negative MD. In cases where MD was the same in both eyes to two decimal places, worse eye was defined as eye with higher IOP. |
Time Frame | Median follow-up of 366.0 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Number [percentage of participants] |
66.3
69.8%
|
86.4
196.4%
|
Title | Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up |
---|---|
Description | The categories = Worsening (<-2), No Change (≥-2 and ≥2), Improving (>2) and Missing were used for determining BCVA worst line change from Baseline. Only categories with at least one participant with event are reported. |
Time Frame | Baseline up to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Worsening |
36.84
38.8%
|
56.82
129.1%
|
No Change |
63.16
66.5%
|
40.91
93%
|
Missing |
0.0
0%
|
2.27
5.2%
|
Title | Pachymetry Based on Change From Baseline In Average Central Corneal Thickness |
---|---|
Description | Pachymetry was measured as average central corneal thickness (microns/micrometer) change from Baseline. |
Time Frame | Baseline (Preoperative) and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. Overall number analyzed are the number of participants with data available for analyses. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 64 | 30 |
Mean (Standard Deviation) [micrometer (µm)] |
-2.0
(21.41)
|
6.4
(12.44)
|
Title | Change From Baseline in Visual Field Examinations Analyzed by Machine Type |
---|---|
Description | All visual field examination data were collected and reported as mean deviation by Humphrey machine. |
Time Frame | Baseline and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. Overall number analyzed are the number of participants with data available for analyses. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 68 | 34 |
Mean (Standard Deviation) [decibel (dB)] |
-0.051
(4.5578)
|
-0.356
(3.0171)
|
Title | Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) |
---|---|
Description | AE=any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. An SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. ADEs and SADEs are AEs and SAEs that are caused by the device |
Time Frame | Median follow-up of 366.0 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants that have undergone study glaucoma surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
TEAEs |
74.7
78.6%
|
93.2
211.8%
|
TESAEs |
9.5
10%
|
4.5
10.2%
|
TEADEs |
0.0
0%
|
0.0
0%
|
TESADEs |
0.0
0%
|
0.0
0%
|
Title | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores |
---|---|
Description | The SHPC-18 is an 18-item questionnaire that asks participants being treated for glaucoma questions about eye symptoms or problems they may experience. There are two domains: Local Eye Symptoms (7 items) subscale score 0 to 700 divided by 7 and Visual Function Problem (11 items) subscale score 0 to 1100 divided by 11. The scores of each subscale ranges from from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A frequency score was calculated by summing the individual response scores of each item, and ranges from 0 to 7 for Local Eye Symptom and from 0 to 11 for Visual Function. A total bothersome score for the SHPC-18 is calculated by summing all 18 items scores, resulting in a range from 0 to 1800, then dividing the sum by 18, to create a total bothersome score ranging from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A negative change from Baseline for all scales and subscales indicates improvement. |
Time Frame | Baseline (Preoperative) to Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with data available for analyses. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 44 | 26 |
Local Eye Symptoms Score |
-3.328
(2.5560)
|
-0.297
(3.4928)
|
Vision Function Problem Score |
-3.064
(2.6759)
|
7.443
(3.6965)
|
Total Bothersome Score |
-3.160
(2.3564)
|
4.368
(3.2737)
|
Local Eye Symptoms Frequency Score |
-0.6
(0.25)
|
-0.1
(0.34)
|
Vision Function Problem Frequency Score |
-0.7
(0.37)
|
1.0
(0.51)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Score | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.485 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -3.031 | |
Confidence Interval |
(2-Sided) 95% -11.5597 to 5.4973 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.3331 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Score | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.022 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -10.507 | |
Confidence Interval |
(2-Sided) 95% -19.5000 to -1.5144 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.5666 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Total Bothersome Score | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.064 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -7.528 | |
Confidence Interval |
(2-Sided) 95% -15.4841 to 0.4275 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.0382 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Frequency Score | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.278 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -1.28 to 0.37 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.42 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Frequency Score | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.007 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -1.7 | |
Confidence Interval |
(2-Sided) 95% -2.96 to -0.47 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.63 |
|
Estimation Comments |
Title | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine |
---|---|
Description | Participants answered the question, "Since your glaucoma surgery, would you consider that you have resumed your usual activities and daily routine?" using the following categories: Not at all, Somewhat, Moderately so, Mostly, Completely. |
Time Frame | Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 95 | 44 |
Not at all |
1.1
1.2%
|
2.3
5.2%
|
Somewhat |
4.2
4.4%
|
9.1
20.7%
|
Moderately so |
4.2
4.4%
|
4.5
10.2%
|
Mostly |
6.3
6.6%
|
20.5
46.6%
|
Completely |
41.1
43.3%
|
31.8
72.3%
|
Missing |
43.2
45.5%
|
31.8
72.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Not at all | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.534 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Somewhat | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.263 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Moderately so | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 1.000 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Mostly | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.018 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Completely | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.350 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Missing | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.264 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health |
---|---|
Description | WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement. |
Time Frame | Baseline (Preoperative) and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analysis at the given timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 5 | 7 |
Least Squares Mean (Standard Error) [percent change] |
-0.994
(12.4333)
|
7.309
(10.3287)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Percent Change From Baseline in Work Productivity and Activity Impairment- Percent Overall Work Impairment Due to Health | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.610 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -8.303 | |
Confidence Interval |
(2-Sided) 95% -40.8681 to 24.2624 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 16.1445 |
|
Estimation Comments |
Title | PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health |
---|---|
Description | WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement. |
Time Frame | Baseline (Preoperative) and Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analysis at the given timepoint. |
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy |
---|---|---|
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). |
Measure Participants | 30 | 19 |
Least Squares Mean (Standard Error) [percent change] |
-3.1
(5.18)
|
10.8
(6.53)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | XEN-45 Gel Stent, Trabeculectomy |
---|---|---|
Comments | PRO: Percent Change From Baseline in Work Productivity and Activity Impairment-Percent Activity Impairment Due to Health | |
Type of Statistical Test | Other | |
Comments | No formal hypothesis was planned. P-value for treatment differences was provided for reference. | |
Statistical Test of Hypothesis | p-Value | 0.097 |
Comments | ||
Method | Mixed Model for Repeated Measures | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Square Mean Difference |
Estimated Value | -13.9 | |
Confidence Interval |
(2-Sided) 95% -30.32 to 2.52 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.33 |
|
Estimation Comments |
Adverse Events
Time Frame | Median follow-up of 366.0 days | |||
---|---|---|---|---|
Adverse Event Reporting Description | All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery. | |||
Arm/Group Title | XEN-45 Gel Stent | Trabeculectomy | ||
Arm/Group Description | Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery). | Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery). | ||
All Cause Mortality |
||||
XEN-45 Gel Stent | Trabeculectomy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/107 (2.8%) | 1/51 (2%) | ||
Serious Adverse Events |
||||
XEN-45 Gel Stent | Trabeculectomy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 9/95 (9.5%) | 2/44 (4.5%) | ||
Cardiac disorders | ||||
CARDIAC ARREST | 1/95 (1.1%) | 1 | 0/44 (0%) | 0 |
Eye disorders | ||||
VISUAL ACUITY REDUCED | 1/95 (1.1%) | 1 | 0/44 (0%) | 0 |
Infections and infestations | ||||
CORONA VIRUS INFECTION | 2/95 (2.1%) | 2 | 0/44 (0%) | 0 |
ENDOPHTHALMITIS | 1/95 (1.1%) | 1 | 0/44 (0%) | 0 |
PERIORBITAL CELLULITIS | 1/95 (1.1%) | 1 | 0/44 (0%) | 0 |
PNEUMONIA | 1/95 (1.1%) | 1 | 0/44 (0%) | 0 |
SEPSIS | 1/95 (1.1%) | 1 | 0/44 (0%) | 0 |
Injury, poisoning and procedural complications | ||||
FALL | 0/95 (0%) | 0 | 1/44 (2.3%) | 1 |
Investigations | ||||
INTRAOCULAR PRESSURE INCREASED | 1/95 (1.1%) | 1 | 0/44 (0%) | 0 |
Nervous system disorders | ||||
PARKINSON'S DISEASE | 1/95 (1.1%) | 1 | 0/44 (0%) | 0 |
Product Issues | ||||
DEVICE EXTRUSION | 1/95 (1.1%) | 1 | 0/44 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
ACUTE RESPIRATORY DISTRESS SYNDROME | 0/95 (0%) | 0 | 1/44 (2.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
XEN-45 Gel Stent | Trabeculectomy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 59/95 (62.1%) | 38/44 (86.4%) | ||
Eye disorders | ||||
CHOROIDAL EFFUSION | 2/95 (2.1%) | 2 | 4/44 (9.1%) | 5 |
DRY EYE | 3/95 (3.2%) | 3 | 3/44 (6.8%) | 3 |
GLAUCOMA | 0/95 (0%) | 0 | 3/44 (6.8%) | 3 |
HYPOTONY OF EYE | 22/95 (23.2%) | 24 | 22/44 (50%) | 32 |
PUNCTATE KERATITIS | 2/95 (2.1%) | 2 | 3/44 (6.8%) | 3 |
VISUAL ACUITY REDUCED | 36/95 (37.9%) | 59 | 24/44 (54.5%) | 39 |
Injury, poisoning and procedural complications | ||||
CONJUNCTIVAL FILTERING BLEB LEAK | 0/95 (0%) | 0 | 7/44 (15.9%) | 9 |
HYPHAEMA | 6/95 (6.3%) | 6 | 3/44 (6.8%) | 3 |
Investigations | ||||
INTRAOCULAR PRESSURE INCREASED | 19/95 (20%) | 23 | 5/44 (11.4%) | 6 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title | Global Medical Services |
---|---|
Organization | AbbVie |
Phone | 800-633-9110 |
abbvieclinicaltrials@abbvie.com |
- CMO-US-EYE-0600