XEN GPS: XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT03654885
Collaborator
(none)
158
35
2
31.4
4.5
0.1

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
  • Device: XEN-45 Gel Stent
  • Procedure: Trabeculectomy
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

Study Type:
Interventional
Actual Enrollment :
158 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
May 13, 2021
Actual Study Completion Date :
May 13, 2021

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

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. Mean Surgically Induced Astigmatism - Autorefractor Reading [Month 12]

  30. Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading [Baseline (Preoperative) and Month 12]

  31. Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites [Baseline (Preoperative), Week 1, and Months 1 and 12]

  32. Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth [Baseline, Day 1 and Week 2]

  33. 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.

  34. Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites [Up to Month 12]

  35. Bleb Morphology - Slit Lamp Photography at Selected Sites [Up to Month 12]

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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

  44. 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.

  45. 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.

  46. 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.

  47. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03654885
Other Study ID Numbers:
  • CMO-US-EYE-0600
First Posted:
Aug 31, 2018
Last Update Posted:
Jul 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Secondary Outcome
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)
3. Secondary Outcome
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
4. Secondary Outcome
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)
5. Secondary Outcome
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
6. Secondary Outcome
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
7. Secondary Outcome
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
8. Secondary Outcome
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
9. Secondary Outcome
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
10. Secondary Outcome
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
11. Secondary Outcome
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
12. Secondary Outcome
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
13. Secondary Outcome
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%
14. Secondary Outcome
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)
15. Secondary Outcome
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
16. Secondary Outcome
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
17. Secondary Outcome
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%
18. Secondary Outcome
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
19. Secondary Outcome
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
20. Secondary Outcome
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
21. Secondary Outcome
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
22. Secondary Outcome
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%
23. Secondary Outcome
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%
24. Secondary Outcome
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%
25. Secondary Outcome
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%
26. Secondary Outcome
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%
27. Secondary Outcome
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%
28. Secondary Outcome
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
29. Secondary Outcome
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
30. Secondary Outcome
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
31. Secondary Outcome
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
32. Secondary Outcome
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
33. Secondary Outcome
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
34. Secondary Outcome
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
35. Secondary Outcome
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
36. Secondary Outcome
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
37. Secondary Outcome
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%
38. Secondary Outcome
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
39. Secondary Outcome
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%
40. Secondary Outcome
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%
41. Secondary Outcome
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%
42. Secondary Outcome
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)
43. Secondary Outcome
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)
44. Secondary Outcome
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%
45. Secondary Outcome
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
46. Secondary Outcome
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
47. Secondary Outcome
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
48. Secondary Outcome
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

[Not Specified]

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
Email abbvieclinicaltrials@abbvie.com
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03654885
Other Study ID Numbers:
  • CMO-US-EYE-0600
First Posted:
Aug 31, 2018
Last Update Posted:
Jul 21, 2022
Last Verified:
Jun 1, 2022