Glaucoma
Conditions
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.
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.
Interventions
DEVICEXEN-45 Gel Stent
XEN-45 gel stent device implant
PROCEDURETrabeculectomy
Trabeculectomy surgery
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Mean IOP Over Time | Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 | IOP is a measurement of the fluid pressure inside the eye. |
| Change From Baseline in Mean IOP Over Time | Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 | IOP is a measurement of the fluid pressure inside the eye. |
| Mean Number of Topical IOP-Lowering Medications Over Time | Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 | IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
| Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 | IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
| Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12 | Baseline (Preoperative) and Month 12 | IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
| Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg | Baseline (Preoperative) and Month 12 | IOP is a measurement of the fluid pressure inside the eye. |
| Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg | Baseline (Preoperative) and Month 12 | Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
| Percentage of Participants Achieving Specific IOP Targets at Month 12 | Month 12 | IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg. |
| Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | Baseline (Preoperative) to Month 12 | IOP is a measurement of fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction. |
| Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 | Baseline (Preoperative) and Month 12 | IOP is a measurement of fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg. |
| Percentage of Participants With Needlings Performed | Up to Month 12 | Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye. |
| Percentage of Eyes Achieving at Least a 20% Reduction in IOP at Month 12 on the Same or Fewer Topical IOP-lowering Medications in Participants Who Had Needlings | Month 12 | IOP is a measurement of fluid pressure inside the eye. Topical IOP-lowering medication classes include: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
| Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings | Month 12 | Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments. |
| Percentage of Participants With Antifibrotic Use During Needling | Up to Month 12 | Antifibrotic use included mitomycin-C (MMC) which was standardized for both groups and administered according to physician training and practice. |
| Percentage of Participants Achieving Complete Success at Month 12 | Month 12 | Complete success was defined as IOP ≤18mm Hg, with 20% or greater IOP lowering from medicated Baseline, on no topical medications, and no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage. |
| Percentage of Participants Achieving Qualified Success at Month 12 | Month12 | Qualified success was defined as IOP ≤18 mm Hg, with 20% or greater IOP lowering from medicated Baseline, taking topical medications at Baseline Qualifying Visit, no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage. |
| Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | Month 12 | IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12. |
| Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | Month 12 | IOP is a measurement of the fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12. |
| Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use | Month 12 | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. |
| Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration | Month 12 | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The time of administration was classified into two categories as: Before Procedure and After Procedure. |
| Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy | Month 12 | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The mode of administration was classified into two categories as: Injection and Other. Other includes all other modes of administration apart from injection. |
| Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy | Month 12 | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The volume of administration measured in milliliters (mL) was classified into three categories as: 0.1, 0.2, and Other. Other includes all other volumes apart from 0.1 and 0.2. |
| Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy | Month 12 | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The concentration of administration measured in milligram per milliliter (mg/mL) was classified into three categories as: 0.2, 0.4, and Other. Other includes all other concentrations apart from 0.2 and 0.4. |
| Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy | Month 12 | Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The absolute dose of administration measured in microgram per milliliter (µg/mL) was classified into two categories as: 40, and Other. Other includes all other concentrations apart from 40. |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Baseline and Day 1, Weeks 1 and 2, and Months 1, 3, 6, 9, and 12 | BCVA was performed using a Snellen eye chart with glasses, and the BCVA data collected in the visual acuity electronic case report form (eCRF) page was analyzed. The number of lines read correctly was assessed as the line change from baseline at each follow-up evaluation and were log transformed. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower and negative logMAR value indicating better visual acuity. |
| Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale | Baseline (Preoperative) and postoperative Months 1, 3, 6, and 12 | Manifest Refraction - Mean Visual Acuity was performed using a Snellen eye chart with glasses. The line change from baseline at each follow-up evaluation in logarithm of the minimum angle of resolution (logMAR) was calculated. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. |
| Mean Surgically Induced Astigmatism - Autorefractor Reading | Month 12 | — |
| Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading | Baseline (Preoperative) and Month 12 | — |
| Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites | Baseline (Preoperative), Week 1, and Months 1 and 12 | — |
| Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth | Baseline, Day 1 and Week 2 | — |
| Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | Baseline, Day 1 and Week 2 | The keratometric values for keratometry (K) measured in 2 meridians (i.e., flat keratometry \[K1\] and steep keratometry \[K2\]) along with Delta (D) were determined. |
| Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites | Up to Month 12 | — |
| Bleb Morphology - Slit Lamp Photography at Selected Sites | Up to Month 12 | — |
| Percentage of Participants With Clinical Hypotony | Month 12 | Clinical hypotony was defined as vision reduction (2 lines or more) related to macular changes consistent with hypotony maculopathy (macular folds), optic disc edema, and/or serous choroidal detachments because of low IOP. |
| Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment | Up to Month 12 | Eyes with IOP 6 mm Hg or less at any time point and relevant clinical assessment (vision reduction \[2 lines or more\] related to macular changes consistent with hypotony maculopathy \[macular folds\], optic disc edema, anterior chamber status, and/or serous choroidal detachments because of low IOP) of these eyes at those time points were assessed. Only data from study eyes are included. The worse eye was selected as the study eye if both eyes met the inclusion criteria. The worse eye was defined using the visual field MD at Baseline, with the worse eye having the most negative MD. In cases where the MD was the same in both eyes to two decimal places, the worse eye was defined as the eye with the higher IOP. |
| Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) | Median follow-up of 366.0 days | An adverse event(AE)is any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. Intraoperative AESIs included- Detached Descemet's membrane,iris damage,lens contact,vitreous bulge or loss,anterior chamber bleeding,retrobulbar hemorrhage,conjunctival perforation,conjunctival or scleral flap tearing,shallow anterior chamber with peripheral iridocorneal touch,flat anterior chamber with iridocorneal touch extending to the pupil,device malfunction identified prior to implantation,and choroidal hemorrhage of effusion. Only categories with at least one participant with event in the study eye are reported. The worse eye was selected as the study eye if both eyes met inclusion criteria. The worse eye was defined using visual field MD at Baseline, with the worse eye having the most negative MD. If MD was same in both eyes to two decimal places, the worse eye=eye with higher IOP. |
| Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs) | Median follow-up of 366.0 days | AE=any untoward medical occurrence in a clinical investigation participant administered drug;it does not necessarily have to have a causal relationship with the treatment. TEAE is an AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Postoperative AEs included but were not limited to: angle recession, anterior chamber changes, BCVA loss,bleb leak, blebitis, cataract, choroidal effusion, chronic pain, corneal edema, cyclodialysis, Dellen, device malfunction, endophthalmitis, fixed dilated pupil, hyphema, hypotony, implant issues, increase in corneal thickness/IOP, explant, iridodialysis, iritis, loss of eye, etc.Worse eye=eye if both eyes met inclusion criteria. Worse eye was defined using visual field MD at Baseline, with worse eye having the most negative MD. In cases where MD was the same in both eyes to two decimal places, worse eye was defined as eye with higher IOP. |
| Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up | Baseline up to Month 12 | The categories = Worsening (\<-2), No Change (≥-2 and ≥2), Improving (\>2) and Missing were used for determining BCVA worst line change from Baseline. Only categories with at least one participant with event are reported. |
| Pachymetry Based on Change From Baseline In Average Central Corneal Thickness | Baseline (Preoperative) and Month 12 | Pachymetry was measured as average central corneal thickness (microns/micrometer) change from Baseline. |
| Change From Baseline in Visual Field Examinations Analyzed by Machine Type | Baseline and Month 12 | All visual field examination data were collected and reported as mean deviation by Humphrey machine. |
| Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) | Median follow-up of 366.0 days | AE=any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. An SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. ADEs and SADEs are AEs and SAEs that are caused by the device |
| Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Baseline (Preoperative) to Month 6 | The SHPC-18 is an 18-item questionnaire that asks participants being treated for glaucoma questions about eye symptoms or problems they may experience. There are two domains: Local Eye Symptoms (7 items) subscale score 0 to 700 divided by 7 and Visual Function Problem (11 items) subscale score 0 to 1100 divided by 11. The scores of each subscale ranges from from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A frequency score was calculated by summing the individual response scores of each item, and ranges from 0 to 7 for Local Eye Symptom and from 0 to 11 for Visual Function. A total bothersome score for the SHPC-18 is calculated by summing all 18 items scores, resulting in a range from 0 to 1800, then dividing the sum by 18, to create a total bothersome score ranging from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A negative change from Baseline for all scales and subscales indicates improvement. |
| PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Month 3 | Participants answered the question, Since your glaucoma surgery, would you consider that you have resumed your usual activities and daily routine? using the following categories: Not at all, Somewhat, Moderately so, Mostly, Completely. |
| PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health | Baseline (Preoperative) and Month 12 | WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement. |
| PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health | Baseline (Preoperative) and Month 12 | WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 95 |
| 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). | 44 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Additional Glaucoma Surgery (Secondary Surgical Intervention [SSI]) | 7 | 1 |
| Overall Study | Additional Ophthalmic Surgery (Not for Intraocular pressure [IOP] Control) | 1 | 0 |
| Overall Study | Adverse Event in Study Eye | 3 | 0 |
| Overall Study | Consent Withdrawn | 1 | 0 |
| Overall Study | Death | 3 | 1 |
| Overall Study | Did Not Meet Inclusion Criteria (IC) Diagnosis of Ocular Hypertension (Dx OHT) | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Randomized, Not Treated: Consent Withdrawn | 5 | 3 |
| Overall Study | Randomized, Not Treated: Investigators Decision (Unrelated to Adverse Event [AE]) | 0 | 3 |
| Overall Study | Randomized, Not Treated: Study on-hold due to Device Recall | 7 | 1 |
Baseline characteristics
| Characteristic | XEN-45 Gel Stent | Trabeculectomy | Total |
|---|---|---|---|
| Age, Continuous | 69.5 years STANDARD_DEVIATION 9.64 | 69.4 years STANDARD_DEVIATION 9.72 | 69.5 years STANDARD_DEVIATION 9.63 |
| Race/Ethnicity, Customized Ethnicity | — | — | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 18 Participants | 10 Participants | 28 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 14 Participants | 8 Participants | 22 Participants |
| Race/Ethnicity, Customized White or Caucasian | 61 Participants | 26 Participants | 87 Participants |
| Sex: Female, Male Female | 41 Participants | 19 Participants | 60 Participants |
| Sex: Female, Male Male | 54 Participants | 25 Participants | 79 Participants |
| Study Eye Intraocular Pressure (IOP) | 23.13 millimetre of mercury (mm Hg) STANDARD_DEVIATION 5.817 | 22.56 millimetre of mercury (mm Hg) STANDARD_DEVIATION 5.653 | 22.95 millimetre of mercury (mm Hg) STANDARD_DEVIATION 5.751 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 107 | 1 / 51 |
| other Total, other adverse events | 59 / 95 | 38 / 44 |
| serious Total, serious adverse events | 9 / 95 | 2 / 44 |
Outcome results
Primary
Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats | 62.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats | 68.2 percentage of participants |
p-value: 0.48795% CI: [-22.9, 10.8]Chi-squared
Secondary
Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites
Time frame: Up to Month 12
Population: No tabular data was collected. Photographs were taken at select sites to be used for publication purposes.
Secondary
Bleb Morphology - Slit Lamp Photography at Selected Sites
Time frame: Up to Month 12
Population: No tabular data was collected. Photographs were taken at select sites to be used for publication purposes.
Secondary
Change From Baseline in Mean IOP at Month 12
IOP is a measurement of the fluid pressure inside the eye.
Time frame: Baseline (Preoperative) and Month 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XEN-45 Gel Stent | Change From Baseline in Mean IOP at Month 12 | -8.25 mm Hg | Standard Error 0.701 |
| Trabeculectomy | Change From Baseline in Mean IOP at Month 12 | -11.02 mm Hg | Standard Error 1.009 |
p-value: 0.02495% CI: [0.358, 5.183]Mixed Model for Repeated Measures
Secondary
Change From Baseline in Mean IOP Over Time
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Change From Baseline in Mean IOP Over Time | Change From Baseline at Day 1 | -13.63 mm Hg | Standard Error 0.645 |
| XEN-45 Gel Stent | Change From Baseline in Mean IOP Over Time | Change From Baseline at Week 1 | -11.56 mm Hg | Standard Error 0.66 |
| XEN-45 Gel Stent | Change From Baseline in Mean IOP Over Time | Change From Baseline at Week 2 | -9.26 mm Hg | Standard Error 0.657 |
| XEN-45 Gel Stent | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 1 | -9.15 mm Hg | Standard Error 0.648 |
| XEN-45 Gel Stent | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 3 | -6.35 mm Hg | Standard Error 0.663 |
| XEN-45 Gel Stent | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 6 | -7.94 mm Hg | Standard Error 0.69 |
| XEN-45 Gel Stent | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 9 | -8.19 mm Hg | Standard Error 0.69 |
| XEN-45 Gel Stent | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 12 | -8.25 mm Hg | Standard Error 0.701 |
| Trabeculectomy | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 12 | -11.02 mm Hg | Standard Error 1.009 |
| Trabeculectomy | Change From Baseline in Mean IOP Over Time | Change From Baseline at Day 1 | -7.82 mm Hg | Standard Error 0.958 |
| Trabeculectomy | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 3 | -11.09 mm Hg | Standard Error 0.977 |
| Trabeculectomy | Change From Baseline in Mean IOP Over Time | Change From Baseline at Week 1 | -11.34 mm Hg | Standard Error 0.958 |
| Trabeculectomy | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 9 | -11.72 mm Hg | Standard Error 0.978 |
| Trabeculectomy | Change From Baseline in Mean IOP Over Time | Change From Baseline at Week 2 | -11.29 mm Hg | Standard Error 0.958 |
| Trabeculectomy | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 6 | -10.95 mm Hg | Standard Error 0.978 |
| Trabeculectomy | Change From Baseline in Mean IOP Over Time | Change From Baseline at Month 1 | -11.37 mm Hg | Standard Error 0.958 |
Comparison: Change From Baseline in Mean IOP Over Time: Day 1p-value: <0.00195% CI: [-8.074, -3.538]Mixed Model for Repeated Measures
Comparison: Change From Baseline in Mean IOP Over Time: Week 1p-value: 0.85195% CI: [-2.503, 2.066]Mixed Model for Repeated Measures
Comparison: Change From Baseline in Mean IOP Over Time: Week 2p-value: 0.08195% CI: [-0.253, 4.309]Mixed Model for Repeated Measures
Comparison: Change From Baseline in Mean IOP Over Time: Month 1p-value: 0.05695% CI: [-0.059, 4.484]Mixed Model for Repeated Measures
Comparison: Change From Baseline in Mean IOP Over Time: Month 3p-value: <0.00195% CI: [2.416, 7.054]Mixed Model for Repeated Measures
Comparison: Change From Baseline in Mean IOP Over Time: Month 6p-value: 0.01295% CI: [0.657, 5.358]Mixed Model for Repeated Measures
Comparison: Change From Baseline in Mean IOP Over Time: Month 9p-value: 0.00395% CI: [1.182, 5.883]Mixed Model for Repeated Measures
Comparison: Change From Baseline in Mean IOP Over Time: Month 12p-value: 0.02495% CI: [0.358, 5.183]Mixed Model for Repeated Measures
Secondary
Change From Baseline in Mean Number of Topical IOP-Lowering Medications at 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.
Time frame: Baseline (Preoperative) and Month 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XEN-45 Gel Stent | Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12 | -1.7 medications | Standard Error 0.08 |
| Trabeculectomy | Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12 | -2.0 medications | Standard Error 0.11 |
p-value: 0.05295% CI: [0, 0.54]Mixed Model for Repeated Measures
Secondary
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Day 1 | -2.1 medications | Standard Error 0.08 |
| XEN-45 Gel Stent | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Week 1 | -2.0 medications | Standard Error 0.08 |
| XEN-45 Gel Stent | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Week 2 | -2.0 medications | Standard Error 0.08 |
| XEN-45 Gel Stent | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 1 | -2.0 medications | Standard Error 0.08 |
| XEN-45 Gel Stent | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 3 | -1.8 medications | Standard Error 0.08 |
| XEN-45 Gel Stent | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 6 | -1.7 medications | Standard Error 0.08 |
| XEN-45 Gel Stent | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 9 | -1.7 medications | Standard Error 0.08 |
| XEN-45 Gel Stent | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 12 | -1.7 medications | Standard Error 0.08 |
| Trabeculectomy | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 12 | -2.0 medications | Standard Error 0.11 |
| Trabeculectomy | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Day 1 | -2.0 medications | Standard Error 0.11 |
| Trabeculectomy | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 3 | -2.2 medications | Standard Error 0.11 |
| Trabeculectomy | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Week 1 | -2.0 medications | Standard Error 0.11 |
| Trabeculectomy | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 9 | -2.0 medications | Standard Error 0.11 |
| Trabeculectomy | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Week 2 | -2.1 medications | Standard Error 0.11 |
| Trabeculectomy | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 6 | -2.0 medications | Standard Error 0.11 |
| Trabeculectomy | Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time | Change From Baseline at Month 1 | -2.1 medications | Standard Error 0.11 |
Comparison: Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Day 1p-value: 0.50595% CI: [-0.36, 0.18]Mixed Model for Repeated Measures
Comparison: Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 1p-value: 0.94995% CI: [-0.28, 0.26]Mixed Model for Repeated Measures
Comparison: Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 2p-value: 0.58195% CI: [-0.19, 0.34]Mixed Model for Repeated Measures
Comparison: Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 1p-value: 0.30295% CI: [-0.13, 0.41]Mixed Model for Repeated Measures
Comparison: Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 3p-value: 0.00595% CI: [0.12, 0.66]Mixed Model for Repeated Measures
Comparison: Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 6p-value: 0.02695% CI: [0.04, 0.59]Mixed Model for Repeated Measures
Comparison: Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 9p-value: 0.0195% CI: [0.09, 0.64]Mixed Model for Repeated Measures
Comparison: Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 12p-value: 0.05295% CI: [0, 0.54]Mixed Model for Repeated Measures
Secondary
Change From Baseline in Visual Field Examinations Analyzed by Machine Type
All visual field examination data were collected and reported as mean deviation by Humphrey machine.
Time frame: Baseline and Month 12
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XEN-45 Gel Stent | Change From Baseline in Visual Field Examinations Analyzed by Machine Type | -0.051 decibel (dB) | Standard Deviation 4.5578 |
| Trabeculectomy | Change From Baseline in Visual Field Examinations Analyzed by Machine Type | -0.356 decibel (dB) | Standard Deviation 3.0171 |
Secondary
Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg
IOP is a measurement of the fluid pressure inside the eye.
Time frame: Baseline (Preoperative) and Month 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XEN-45 Gel Stent | Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg | -2.83 mm Hg | Standard Error 1.281 |
| Trabeculectomy | Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg | -4.61 mm Hg | Standard Error 1.801 |
p-value: 0.42195% CI: [-2.579, 6.151]Mixed model repeated measures
Secondary
Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XEN-45 Gel Stent | Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg | -1.8 medications | Standard Error 0.15 |
| Trabeculectomy | Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg | -2.1 medications | Standard Error 0.2 |
p-value: 0.1895% CI: [-0.16, 0.84]Mixed Model for Repeated Measures
Secondary
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Day 1 | -1.4 Log10 (Lines) | Standard Error 0.2 |
| XEN-45 Gel Stent | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Week 1 | -1.2 Log10 (Lines) | Standard Error 0.2 |
| XEN-45 Gel Stent | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Week 2 | -1.1 Log10 (Lines) | Standard Error 0.2 |
| XEN-45 Gel Stent | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 1 | -0.6 Log10 (Lines) | Standard Error 0.2 |
| XEN-45 Gel Stent | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 3 | -0.4 Log10 (Lines) | Standard Error 0.2 |
| XEN-45 Gel Stent | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 6 | -0.4 Log10 (Lines) | Standard Error 0.21 |
| XEN-45 Gel Stent | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 9 | -0.4 Log10 (Lines) | Standard Error 0.21 |
| XEN-45 Gel Stent | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 12 | -0.1 Log10 (Lines) | Standard Error 0.21 |
| Trabeculectomy | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 12 | -0.8 Log10 (Lines) | Standard Error 0.31 |
| Trabeculectomy | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Day 1 | -2.5 Log10 (Lines) | Standard Error 0.29 |
| Trabeculectomy | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 3 | -0.5 Log10 (Lines) | Standard Error 0.3 |
| Trabeculectomy | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Week 1 | -2.4 Log10 (Lines) | Standard Error 0.29 |
| Trabeculectomy | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 9 | -1.0 Log10 (Lines) | Standard Error 0.3 |
| Trabeculectomy | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Week 2 | -1.6 Log10 (Lines) | Standard Error 0.29 |
| Trabeculectomy | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 6 | -0.4 Log10 (Lines) | Standard Error 0.3 |
| Trabeculectomy | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses | Change From Baseline at Month 1 | -1.1 Log10 (Lines) | Standard Error 0.3 |
Comparison: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses: Day 1p-value: 0.00495% CI: [0.33, 1.72]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 1p-value: 0.00195% CI: [0.47, 1.88]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 2p-value: 0.16295% CI: [-0.2, 1.2]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 1p-value: 0.18595% CI: [-0.23, 1.19]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 3p-value: 0.84695% CI: [-0.64, 0.79]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 6p-value: 0.96595% CI: [-0.73, 0.7]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 9p-value: 0.09695% CI: [-0.11, 1.33]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 12p-value: 0.06395% CI: [-0.04, 1.43]Mixed Model for Repeated Measures
Secondary
Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale | Change From Baseline at Month 1 | 0.05 logMAR | Standard Error 0.015 |
| XEN-45 Gel Stent | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale | Change From Baseline at Month 3 | 0.04 logMAR | Standard Error 0.016 |
| XEN-45 Gel Stent | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale | Change From Baseline at Month 6 | 0.04 logMAR | Standard Error 0.016 |
| XEN-45 Gel Stent | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale | Change From Baseline at Month 12 | 0.01 logMAR | Standard Error 0.016 |
| Trabeculectomy | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale | Change From Baseline at Month 12 | 0.07 logMAR | Standard Error 0.022 |
| Trabeculectomy | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale | Change From Baseline at Month 1 | 0.10 logMAR | Standard Error 0.022 |
| Trabeculectomy | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale | Change From Baseline at Month 6 | 0.04 logMAR | Standard Error 0.022 |
| Trabeculectomy | Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale | Change From Baseline at Month 3 | 0.05 logMAR | Standard Error 0.022 |
Comparison: Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 1p-value: 0.04895% CI: [-0.105, 0]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 3p-value: 0.74295% CI: [-0.062, 0.045]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 6p-value: 0.92595% CI: [-0.056, 0.051]Mixed Model for Repeated Measures
Comparison: Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 12p-value: 0.02195% CI: [-0.118, -0.01]Mixed Model for Repeated Measures
Secondary
Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth
Time frame: Baseline, Day 1 and Week 2
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth | Change from Baseline at Day 1 | -0.183 millimeter | Standard Error 0.1295 |
| XEN-45 Gel Stent | Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth | Change from Baseline at Week 2 | -0.206 millimeter | Standard Error 0.1195 |
| Trabeculectomy | Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth | Change from Baseline at Day 1 | -0.182 millimeter | Standard Error 0.1553 |
| Trabeculectomy | Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth | Change from Baseline at Week 2 | -0.427 millimeter | Standard Error 0.1732 |
Comparison: Mean Change in Optical Biometry - Anterior Chamber Depth at Day 1p-value: 0.99795% CI: [-0.4103, 0.4086]Mixed Model for Repeated Measures
Comparison: Mean Change in Optical Biometry - Anterior Chamber Depth at Week 2p-value: 0.30295% CI: [-0.2068, 0.6506]Mixed Model for Repeated Measures
Secondary
Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading
Time frame: Baseline (Preoperative) and Month 12
Population: No data is reported due to inaccuracy of the results (autorefractor reading errors).
Secondary
Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites
Time frame: Baseline (Preoperative), Week 1, and Months 1 and 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites | Change From Baseline at Month 12 | 0.106 diopters | Standard Error 0.1976 |
| XEN-45 Gel Stent | Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites | Change From Baseline at Week 1 | 0.057 diopters | Standard Error 0.1861 |
| XEN-45 Gel Stent | Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites | Change From Baseline at Month 1 | 0.187 diopters | Standard Error 0.1931 |
| Trabeculectomy | Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites | Change From Baseline at Month 12 | 0.558 diopters | Standard Error 0.286 |
| Trabeculectomy | Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites | Change From Baseline at Week 1 | 0.619 diopters | Standard Error 0.2639 |
| Trabeculectomy | Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites | Change From Baseline at Month 1 | 0.326 diopters | Standard Error 0.2741 |
Comparison: Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Week 1p-value: 0.08795% CI: [-1.2082, 0.0851]Mixed Model for Repeated Measures
Comparison: Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 1p-value: 0.68295% CI: [-0.809, 0.5324]Mixed Model for Repeated Measures
Comparison: Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 12p-value: 0.19995% CI: [-1.1483, 0.2434]Mixed Model for Repeated Measures
Secondary
Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | K1, Change from Baseline at Day 1 | -0.103 diopter | Standard Error 0.2195 |
| XEN-45 Gel Stent | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | K1, Change from Baseline at Week 2 | 0.156 diopter | Standard Error 0.1973 |
| XEN-45 Gel Stent | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | K2, Change from Baseline at Day 1 | 0.373 diopter | Standard Error 0.2947 |
| XEN-45 Gel Stent | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | K2, Change from Baseline at Week 2 | 0.152 diopter | Standard Error 0.2626 |
| XEN-45 Gel Stent | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | Delta D, Change from Baseline at Day 1 | 0.514 diopter | Standard Error 0.2967 |
| XEN-45 Gel Stent | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | Delta D, Change from Baseline at Week 2 | 0.087 diopter | Standard Error 0.2636 |
| Trabeculectomy | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | Delta D, Change from Baseline at Day 1 | 1.279 diopter | Standard Error 0.3372 |
| Trabeculectomy | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | K1, Change from Baseline at Day 1 | -0.446 diopter | Standard Error 0.2512 |
| Trabeculectomy | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | K2, Change from Baseline at Week 2 | 0.640 diopter | Standard Error 0.3499 |
| Trabeculectomy | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | K1, Change from Baseline at Week 2 | -0.105 diopter | Standard Error 0.2618 |
| Trabeculectomy | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | Delta D, Change from Baseline at Week 2 | 0.664 diopter | Standard Error 0.3527 |
| Trabeculectomy | Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D | K2, Change from Baseline at Day 1 | 0.783 diopter | Standard Error 0.3342 |
Comparison: Mean Change in from Baseline Optical Biometry - K1 at Day 1p-value: 0.30995% CI: [-0.3289, 1.0154]Mixed Model for Repeated Measures
Comparison: Mean Change in from Baseline Optical Biometry - K1 at Week 2p-value: 0.4395% CI: [-0.3993, 0.922]Mixed Model for Repeated Measures
Comparison: Mean Change in from Baseline Optical Biometry - K2 at Day 1p-value: 0.36395% CI: [-1.3071, 0.4882]Mixed Model for Repeated Measures
Comparison: Mean Change in from Baseline Optical Biometry - K2 at Week 2p-value: 0.27295% CI: [-1.3709, 0.3954]Mixed Model for Repeated Measures
Comparison: Mean Change in from Baseline Optical Biometry - Delta D at Day 1p-value: 0.09695% CI: [-1.6722, 0.142]Mixed Model for Repeated Measures
Comparison: Mean Change in from Baseline Optical Biometry - Delta D at Week 2p-value: 0.19895% CI: [-1.4655, 0.3129]Mixed Model for Repeated Measures
Secondary
Mean IOP Over Time
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Mean IOP Over Time | Day 1 | 9.25 mm Hg | Standard Deviation 4.71 |
| XEN-45 Gel Stent | Mean IOP Over Time | Month 3 | 16.46 mm Hg | Standard Deviation 7.407 |
| XEN-45 Gel Stent | Mean IOP Over Time | Week 2 | 13.64 mm Hg | Standard Deviation 8.363 |
| XEN-45 Gel Stent | Mean IOP Over Time | Week 1 | 11.27 mm Hg | Standard Deviation 6.864 |
| XEN-45 Gel Stent | Mean IOP Over Time | Month 9 | 14.57 mm Hg | Standard Deviation 4.221 |
| XEN-45 Gel Stent | Mean IOP Over Time | Month 1 | 13.72 mm Hg | Standard Deviation 6.315 |
| XEN-45 Gel Stent | Mean IOP Over Time | Month 12 | 14.43 mm Hg | Standard Deviation 4.06 |
| XEN-45 Gel Stent | Mean IOP Over Time | Month 6 | 14.86 mm Hg | Standard Deviation 4.228 |
| Trabeculectomy | Mean IOP Over Time | Month 12 | 11.83 mm Hg | Standard Deviation 3.525 |
| Trabeculectomy | Mean IOP Over Time | Day 1 | 15.00 mm Hg | Standard Deviation 13.025 |
| Trabeculectomy | Mean IOP Over Time | Week 1 | 11.48 mm Hg | Standard Deviation 7.323 |
| Trabeculectomy | Mean IOP Over Time | Week 2 | 11.53 mm Hg | Standard Deviation 5.503 |
| Trabeculectomy | Mean IOP Over Time | Month 1 | 11.45 mm Hg | Standard Deviation 5.645 |
| Trabeculectomy | Mean IOP Over Time | Month 3 | 11.59 mm Hg | Standard Deviation 4.672 |
| Trabeculectomy | Mean IOP Over Time | Month 6 | 11.72 mm Hg | Standard Deviation 5.242 |
| Trabeculectomy | Mean IOP Over Time | Month 9 | 11.02 mm Hg | Standard Deviation 3.535 |
Secondary
Mean Number of Needlings Per Eye
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XEN-45 Gel Stent | Mean Number of Needlings Per Eye | 1.7 needlings | Standard Deviation 1.03 |
| Trabeculectomy | Mean Number of Needlings Per Eye | 1.4 needlings | Standard Deviation 0.74 |
Secondary
Mean Number of Topical IOP-Lowering Medications Over Time
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Mean Number of Topical IOP-Lowering Medications Over Time | Day 1 | 0.2 medications | Standard Deviation 0.51 |
| XEN-45 Gel Stent | Mean Number of Topical IOP-Lowering Medications Over Time | Week 1 | 0.3 medications | Standard Deviation 0.77 |
| XEN-45 Gel Stent | Mean Number of Topical IOP-Lowering Medications Over Time | Week 2 | 0.3 medications | Standard Deviation 0.64 |
| XEN-45 Gel Stent | Mean Number of Topical IOP-Lowering Medications Over Time | Month 1 | 0.3 medications | Standard Deviation 0.75 |
| XEN-45 Gel Stent | Mean Number of Topical IOP-Lowering Medications Over Time | Month 3 | 0.5 medications | Standard Deviation 0.89 |
| XEN-45 Gel Stent | Mean Number of Topical IOP-Lowering Medications Over Time | Month 6 | 0.6 medications | Standard Deviation 0.96 |
| XEN-45 Gel Stent | Mean Number of Topical IOP-Lowering Medications Over Time | Month 9 | 0.6 medications | Standard Deviation 1.09 |
| XEN-45 Gel Stent | Mean Number of Topical IOP-Lowering Medications Over Time | Month 12 | 0.6 medications | Standard Deviation 0.95 |
| Trabeculectomy | Mean Number of Topical IOP-Lowering Medications Over Time | Month 12 | 0.3 medications | Standard Deviation 0.5 |
| Trabeculectomy | Mean Number of Topical IOP-Lowering Medications Over Time | Day 1 | 0.3 medications | Standard Deviation 0.53 |
| Trabeculectomy | Mean Number of Topical IOP-Lowering Medications Over Time | Month 3 | 0.1 medications | Standard Deviation 0.26 |
| Trabeculectomy | Mean Number of Topical IOP-Lowering Medications Over Time | Week 1 | 0.3 medications | Standard Deviation 0.73 |
| Trabeculectomy | Mean Number of Topical IOP-Lowering Medications Over Time | Month 9 | 0.2 medications | Standard Deviation 0.49 |
| Trabeculectomy | Mean Number of Topical IOP-Lowering Medications Over Time | Week 2 | 0.2 medications | Standard Deviation 0.53 |
| Trabeculectomy | Mean Number of Topical IOP-Lowering Medications Over Time | Month 6 | 0.2 medications | Standard Deviation 0.58 |
| Trabeculectomy | Mean Number of Topical IOP-Lowering Medications Over Time | Month 1 | 0.1 medications | Standard Deviation 0.52 |
Secondary
Mean Surgically Induced Astigmatism - Autorefractor Reading
Time frame: Month 12
Population: No data is reported due to inaccuracy of the results (autorefractor reading errors).
Secondary
Pachymetry Based on Change From Baseline In Average Central Corneal Thickness
Pachymetry was measured as average central corneal thickness (microns/micrometer) change from Baseline.
Time frame: Baseline (Preoperative) and Month 12
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XEN-45 Gel Stent | Pachymetry Based on Change From Baseline In Average Central Corneal Thickness | -2.0 micrometer (µm) | Standard Deviation 21.41 |
| Trabeculectomy | Pachymetry Based on Change From Baseline In Average Central Corneal Thickness | 6.4 micrometer (µm) | Standard Deviation 12.44 |
Secondary
Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| XEN-45 Gel Stent | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Vision Function Problem Score | -3.064 score on a scale | Standard Error 2.6759 |
| XEN-45 Gel Stent | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Local Eye Symptoms Frequency Score | -0.6 score on a scale | Standard Error 0.25 |
| XEN-45 Gel Stent | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Total Bothersome Score | -3.160 score on a scale | Standard Error 2.3564 |
| XEN-45 Gel Stent | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Vision Function Problem Frequency Score | -0.7 score on a scale | Standard Error 0.37 |
| XEN-45 Gel Stent | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Local Eye Symptoms Score | -3.328 score on a scale | Standard Error 2.556 |
| Trabeculectomy | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Vision Function Problem Frequency Score | 1.0 score on a scale | Standard Error 0.51 |
| Trabeculectomy | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Local Eye Symptoms Score | -0.297 score on a scale | Standard Error 3.4928 |
| Trabeculectomy | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Vision Function Problem Score | 7.443 score on a scale | Standard Error 3.6965 |
| Trabeculectomy | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Total Bothersome Score | 4.368 score on a scale | Standard Error 3.2737 |
| Trabeculectomy | Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores | Local Eye Symptoms Frequency Score | -0.1 score on a scale | Standard Error 0.34 |
Comparison: PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Scorep-value: 0.48595% CI: [-11.5597, 5.4973]Mixed Model for Repeated Measures
Comparison: PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Scorep-value: 0.02295% CI: [-19.5, -1.5144]Mixed Model for Repeated Measures
Comparison: PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Total Bothersome Scorep-value: 0.06495% CI: [-15.4841, 0.4275]Mixed Model for Repeated Measures
Comparison: PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Frequency Scorep-value: 0.27895% CI: [-1.28, 0.37]Mixed Model for Repeated Measures
Comparison: PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Frequency Scorep-value: 0.00795% CI: [-2.96, -0.47]Mixed Model for Repeated Measures
Secondary
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
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | 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 | 87.5 percentage of eyes |
| Trabeculectomy | 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 | 85.7 percentage of eyes |
p-value: 195% CI: [-41.6, 44.1]Fisher Exact
Secondary
Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings | 42.9 percentage of eyes |
| Trabeculectomy | Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings | 75.0 percentage of eyes |
p-value: 0.21595% CI: [-66.8, 10]Fisher Exact
Secondary
Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment
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
Population: Safety Population included all enrolled participants/eyes that have undergone study glaucoma surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment | 13.7 percentage of eyes |
| Trabeculectomy | Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment | 29.5 percentage of eyes |
Secondary
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | 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 | IOP Target ≤16 mm Hg | 56.8 percentage of participants |
| XEN-45 Gel Stent | 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 | IOP Target ≤14 mm Hg | 50.5 percentage of participants |
| XEN-45 Gel Stent | 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 | IOP Target ≤17 mm Hg | 58.9 percentage of participants |
| XEN-45 Gel Stent | 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 | IOP Target ≤13 mm Hg | 36.8 percentage of participants |
| XEN-45 Gel Stent | 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 | IOP Target ≤15 mm Hg | 55.8 percentage of participants |
| XEN-45 Gel Stent | 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 | IOP Target ≤12 mm Hg | 30.5 percentage of participants |
| XEN-45 Gel Stent | 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 | IOP Target ≤18 mm Hg | 61.1 percentage of participants |
| Trabeculectomy | 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 | IOP Target ≤12 mm Hg | 43.2 percentage of participants |
| Trabeculectomy | 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 | IOP Target ≤18 mm Hg | 72.7 percentage of participants |
| Trabeculectomy | 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 | IOP Target ≤17 mm Hg | 70.5 percentage of participants |
| Trabeculectomy | 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 | IOP Target ≤16 mm Hg | 70.5 percentage of participants |
| Trabeculectomy | 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 | IOP Target ≤15 mm Hg | 70.5 percentage of participants |
| Trabeculectomy | 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 | IOP Target ≤14 mm Hg | 61.4 percentage of participants |
| Trabeculectomy | 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 | IOP Target ≤13 mm Hg | 54.5 percentage of participants |
Comparison: 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 Hgp-value: 0.25295% CI: [-29, 6.3]Fisher Exact
Comparison: 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 mmHgp-value: 0.25895% CI: [-28.9, 6.5]Fisher Exact
Comparison: 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 Hgp-value: 0.13995% CI: [-30.9, 4.4]Fisher Exact
Comparison: 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 Hgp-value: 0.13695% CI: [-32, 3.3]Fisher Exact
Comparison: 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 Hgp-value: 0.27495% CI: [-28.2, 7.1]Fisher Exact
Comparison: 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 Hgp-value: 0.06595% CI: [-35, 0.3]Fisher Exact
Comparison: 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 mmHgp-value: 0.1895% CI: [-30.1, 5.2]Fisher Exact
Secondary
Percentage of Participants Achieving Complete Success at 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.
Time frame: Month 12
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants Achieving Complete Success at Month 12 | 44.2 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Complete Success at Month 12 | 59.1 percentage of participants |
p-value: 0.14495% CI: [-32.2, 3.1]Fisher Exact
Secondary
Percentage of Participants Achieving Qualified Success at Month 12
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants Achieving Qualified Success at Month 12 | 62.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Qualified Success at Month 12 | 72.7 percentage of participants |
p-value: 0.25495% CI: [-28, 7.3]Fisher Exact
Secondary
Percentage of Participants Achieving Specific IOP Targets at 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.
Time frame: Month 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤16 mm Hg | 62.1 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤14 mm Hg | 50.5 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤17 mm Hg | 64.2 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤13 mm Hg | 36.8 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤15 mm Hg | 55.8 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤12 mm Hg | 30.5 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤18 mm Hg | 68.4 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤12 mm Hg | 43.2 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤18 mm Hg | 84.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤17 mm Hg | 79.5 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤16 mm Hg | 79.5 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤15 mm Hg | 72.7 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤14 mm Hg | 63.6 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 | IOP Value of ≤13 mm Hg | 56.8 percentage of participants |
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤18 mmHgp-value: 0.06495% CI: [-33, 2.3]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤17 mmHgp-value: 0.07895% CI: [-32.7, 2.5]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤16 mmHgp-value: 0.05195% CI: [-34.7, 0.4]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤15 mmHgp-value: 0.06495% CI: [-34.1, 1]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤14 mm Hgp-value: 0.295% CI: [-30.5, 4.8]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤13 mm Hgp-value: 0.04295% CI: [-37.1, -2]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤12 mm Hgp-value: 0.1895% CI: [-30.1, 5.2]Fisher Exact
Secondary
Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤16 mm Hg | 71.2 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤14 mm Hg | 59.3 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤17 mm Hg | 74.6 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤13 mm Hg | 47.5 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤15 mm Hg | 64.4 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤12 mm Hg | 37.3 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤18 mm Hg | 79.7 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤12 mm Hg | 58.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤18 mm Hg | 87.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤17 mm Hg | 87.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤16 mm Hg | 87.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤15 mm Hg | 83.9 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤14 mm Hg | 80.6 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye | IOP Target ≤13 mm Hg | 71.0 percentage of participants |
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤18 mm Hgp-value: 0.56395% CI: [-28.6, 14.2]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤17 mm Hgp-value: 0.18895% CI: [-33.5, 9.1]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤16 mmHgp-value: 0.11895% CI: [-36.7, 5.6]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤15 mm Hgp-value: 0.08595% CI: [-40.2, 2.1]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤14 mm Hgp-value: 0.05995% CI: [-42, 0.4]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤13 mm Hgp-value: 0.04595% CI: [-43.9, -1.4]Fisher Exact
Comparison: Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤12 mm Hgp-value: 0.07695% CI: [-41.3, 1.1]Fisher Exact
Secondary
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at 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.
Time frame: Baseline (Preoperative) to Month 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥25% IOP Reduction | 60.0 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥30% IOP Reduction | 48.4 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥35% IOP Reduction | 41.1 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥40% IOP Reduction | 35.8 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥45% IOP Reduction | 25.3 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥50% IOP Reduction | 22.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥45% IOP Reduction | 43.2 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥25% IOP Reduction | 63.6 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥40% IOP Reduction | 54.5 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥30% IOP Reduction | 61.4 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥50% IOP Reduction | 43.2 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 | ≥35% IOP Reduction | 61.4 percentage of participants |
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥30% IOP Reductionp-value: 0.20195% CI: [-30.3, 5]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥35% IOP Reductionp-value: 0.0395% CI: [-37.3, -2.3]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥25% IOP Reductionp-value: 0.71295% CI: [-21.3, 14.2]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥40% IOP Reductionp-value: 0.04395% CI: [-36, -0.8]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥45% IOP Reductionp-value: 0.04895% CI: [-35.1, 0]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥50% IOP Reductionp-value: 0.01595% CI: [-38.1, -3.2]Fisher Exact
Secondary
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥25% IOP Reduction | 67.8 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥30% IOP Reduction | 57.6 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥35% IOP Reduction | 50.8 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥40% IOP Reduction | 44.1 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥45% IOP Reduction | 30.5 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥50% IOP Reduction | 27.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥45% IOP Reduction | 58.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥25% IOP Reduction | 77.4 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥40% IOP Reduction | 67.7 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥30% IOP Reduction | 77.4 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥50% IOP Reduction | 58.1 percentage of participants |
| Trabeculectomy | Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes | ≥35% IOP Reduction | 77.4 percentage of participants |
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥ 25% IOP Reductionp-value: 0.46495% CI: [-31, 12.1]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥30% IOP Reductionp-value: 0.06995% CI: [-40.6, 2.1]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥35% IOP Reductionp-value: 0.02395% CI: [-46.9, -4.7]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥40% IOP Reductionp-value: 0.04695% CI: [-43.9, -1.6]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥45% IOP Reductionp-value: 0.01495% CI: [-47.6, -5.9]Fisher Exact
Comparison: Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥50% IOP Reductionp-value: 0.00695% CI: [-50.8, -9.5]Fisher Exact
Secondary
Percentage of Participants With Antifibrotic Use During Needling
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Antifibrotic Use During Needling | 16.8 percentage of participants |
| Trabeculectomy | Percentage of Participants With Antifibrotic Use During Needling | 15.9 percentage of participants |
Secondary
Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs)
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
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) | TEAEs | 74.7 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) | TESAEs | 9.5 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) | TEADEs | 0.0 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) | TESADEs | 0.0 percentage of participants |
| Trabeculectomy | Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) | TESADEs | 0.0 percentage of participants |
| Trabeculectomy | Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) | TEAEs | 93.2 percentage of participants |
| Trabeculectomy | Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) | TEADEs | 0.0 percentage of participants |
| Trabeculectomy | Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) | TESAEs | 4.5 percentage of participants |
Secondary
Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up | Worsening | 36.84 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up | No Change | 63.16 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up | Missing | 0.0 percentage of participants |
| Trabeculectomy | Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up | Worsening | 56.82 percentage of participants |
| Trabeculectomy | Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up | No Change | 40.91 percentage of participants |
| Trabeculectomy | Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up | Missing | 2.27 percentage of participants |
Secondary
Percentage of Participants With Clinical Hypotony
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
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Clinical Hypotony | 23.2 percentage of participants |
| Trabeculectomy | Percentage of Participants With Clinical Hypotony | 50.0 percentage of participants |
Secondary
Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy
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
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy | 40 | 97.9 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy | Other | 1.1 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy | Other | 0 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy | 40 | 93.2 percentage of participants |
Secondary
Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy
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
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy | 0.2 | 34.7 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy | 0.4 | 64.2 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy | Other | 0 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy | 0.2 | 36.4 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy | 0.4 | 56.8 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy | Other | 0 percentage of participants |
Secondary
Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy
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
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy | Injection | 98.9 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy | Other | 0 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy | Injection | 84.1 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy | Other | 13.6 percentage of participants |
Secondary
Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy
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
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy | 0.1 | 50.5 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy | 0.2 | 47.4 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy | Other | 1.1 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy | 0.1 | 34.1 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy | 0.2 | 56.8 percentage of participants |
| Trabeculectomy | Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy | Other | 2.3 percentage of participants |
Secondary
Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration
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
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration | Before Procedure | 37.9 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration | After Procedure | 61.1 percentage of participants |
| Trabeculectomy | Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration | Before Procedure | 56.8 percentage of participants |
| Trabeculectomy | Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration | After Procedure | 40.9 percentage of participants |
Secondary
Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use
Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice.
Time frame: Month 12
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use | 98.9 percentage of participants |
| Trabeculectomy | Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use | 97.7 percentage of participants |
Secondary
Percentage of Participants With Needlings Performed
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Needlings Performed | 23.2 percentage of participants |
| Trabeculectomy | Percentage of Participants With Needlings Performed | 18.2 percentage of participants |
Secondary
Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs)
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
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs) | 66.3 percentage of participants |
| Trabeculectomy | Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs) | 86.4 percentage of participants |
Secondary
Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs)
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
Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) | Anterior Chamber Bleeding | 1.1 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) | Other | 1.1 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) | Conjunctival Buttonhole | 0.0 percentage of participants |
| XEN-45 Gel Stent | Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) | Iris Damage | 0.0 percentage of participants |
| Trabeculectomy | Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) | Iris Damage | 2.3 percentage of participants |
| Trabeculectomy | Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) | Anterior Chamber Bleeding | 4.5 percentage of participants |
| Trabeculectomy | Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) | Conjunctival Buttonhole | 2.3 percentage of participants |
| Trabeculectomy | Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) | Other | 2.3 percentage of participants |
Secondary
PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XEN-45 Gel Stent | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Not at all | 1.1 percentage of participants |
| XEN-45 Gel Stent | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Somewhat | 4.2 percentage of participants |
| XEN-45 Gel Stent | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Moderately so | 4.2 percentage of participants |
| XEN-45 Gel Stent | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Mostly | 6.3 percentage of participants |
| XEN-45 Gel Stent | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Completely | 41.1 percentage of participants |
| XEN-45 Gel Stent | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Missing | 43.2 percentage of participants |
| Trabeculectomy | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Completely | 31.8 percentage of participants |
| Trabeculectomy | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Not at all | 2.3 percentage of participants |
| Trabeculectomy | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Mostly | 20.5 percentage of participants |
| Trabeculectomy | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Somewhat | 9.1 percentage of participants |
| Trabeculectomy | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Missing | 31.8 percentage of participants |
| Trabeculectomy | PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine | Moderately so | 4.5 percentage of participants |
Comparison: PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Not at allp-value: 0.534Fisher Exact
Comparison: PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Somewhatp-value: 0.263Fisher Exact
Comparison: PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Moderately sop-value: 1Fisher Exact
Comparison: PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Mostlyp-value: 0.018Fisher Exact
Comparison: PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Completelyp-value: 0.35Fisher Exact
Comparison: PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Missingp-value: 0.264Fisher Exact
Secondary
PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XEN-45 Gel Stent | PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health | -0.994 percent change | Standard Error 12.4333 |
| Trabeculectomy | PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health | 7.309 percent change | Standard Error 10.3287 |
Comparison: PRO: Percent Change From Baseline in Work Productivity and Activity Impairment- Percent Overall Work Impairment Due to Healthp-value: 0.6195% CI: [-40.8681, 24.2624]Mixed Model for Repeated Measures
Secondary
PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XEN-45 Gel Stent | PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health | -3.1 percent change | Standard Error 5.18 |
| Trabeculectomy | PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health | 10.8 percent change | Standard Error 6.53 |
Comparison: PRO: Percent Change From Baseline in Work Productivity and Activity Impairment-Percent Activity Impairment Due to Healthp-value: 0.09795% CI: [-30.32, 2.52]Mixed Model for Repeated Measures