A Phase 4 interventional study of XEN-45 Gel Stent and Trabeculectomy in Glaucoma, sponsored by Allergan. Completed at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Allergan · Phase 4, Interventional, and Treatment
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.
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 158 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).
Device: XEN-45 Gel Stent
Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Procedure: Trabeculectomy
XEN-45 gel stent device implant
Trabeculectomy surgery
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Mean Surgically Induced Astigmatism - Autorefractor Reading
Time frame: Month 12
Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading
Time frame: Baseline (Preoperative) and Month 12
Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites
Time frame: Baseline (Preoperative), Week 1, and Months 1 and 12
Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth
Time frame: Baseline, Day 1 and Week 2
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
Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites
Time frame: Up to Month 12
Bleb Morphology - Slit Lamp Photography at Selected Sites
Time frame: Up to Month 12
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Started | 107 | 51 |
| Intent-to-treat (itt) population | 95 | 44 |
| Safety population | 95 | 44 |
| Completed | 77 | 38 |
| Not completed | 30 | 13 |
| Withdrew: Randomized, not treated: consent withdrawn | 5 | 3 |
| Withdrew: Randomized, not treated: investigators decision (unrelated to adverse event [ae]) | 0 | 3 |
| Withdrew: Randomized, not treated: study on-hold due to device recall | 7 | 1 |
| Withdrew: Additional glaucoma surgery (secondary surgical intervention [ssi]) | 7 | 1 |
| Withdrew: Additional ophthalmic surgery (not for intraocular pressure [iop] control) | 1 | 0 |
| Withdrew: Adverse event in study eye | 3 | 0 |
| Withdrew: Consent withdrawn | 1 | 0 |
| Withdrew: Death | 3 | 1 |
| Withdrew: Did not meet inclusion criteria (ic) diagnosis of ocular hypertension (dx oht) | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 3 |
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.
| percentage of participants | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats | 62.1 | 68.2 |
IOP is a measurement of the fluid pressure inside the eye.
| mm Hg | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Day 1 | 9.25 ± 4.710 | 15.00 ± 13.025 |
| Week 1 | 11.27 ± 6.864 | 11.48 ± 7.323 |
| Week 2 | 13.64 ± 8.363 | 11.53 ± 5.503 |
| Month 1 | 13.72 ± 6.315 | 11.45 ± 5.645 |
| Month 3 | 16.46 ± 7.407 | 11.59 ± 4.672 |
| Month 6 | 14.86 ± 4.228 | 11.72 ± 5.242 |
| Month 9 | 14.57 ± 4.221 | 11.02 ± 3.535 |
| Month 12 | 14.43 ± 4.060 | 11.83 ± 3.525 |
IOP is a measurement of the fluid pressure inside the eye.
| mm Hg | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change From Baseline at Day 1 | -13.63 ± 0.645 | -7.82 ± 0.958 |
| Change From Baseline at Week 1 | -11.56 ± 0.660 | -11.34 ± 0.958 |
| Change From Baseline at Week 2 | -9.26 ± 0.657 | -11.29 ± 0.958 |
| Change From Baseline at Month 1 | -9.15 ± 0.648 | -11.37 ± 0.958 |
| Change From Baseline at Month 3 | -6.35 ± 0.663 | -11.09 ± 0.977 |
| Change From Baseline at Month 6 | -7.94 ± 0.690 | -10.95 ± 0.978 |
| Change From Baseline at Month 9 | -8.19 ± 0.690 | -11.72 ± 0.978 |
| Change From Baseline at Month 12 | -8.25 ± 0.701 | -11.02 ± 1.009 |
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.
| medications | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Day 1 | 0.2 ± 0.51 | 0.3 ± 0.53 |
| Week 1 | 0.3 ± 0.77 | 0.3 ± 0.73 |
| Week 2 | 0.3 ± 0.64 | 0.2 ± 0.53 |
| Month 1 | 0.3 ± 0.75 | 0.1 ± 0.52 |
| Month 3 | 0.5 ± 0.89 | 0.1 ± 0.26 |
| Month 6 | 0.6 ± 0.96 | 0.2 ± 0.58 |
| Month 9 | 0.6 ± 1.09 | 0.2 ± 0.49 |
| Month 12 | 0.6 ± 0.95 | 0.3 ± 0.50 |
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.
| medications | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change From Baseline at Day 1 | -2.1 ± 0.08 | -2.0 ± 0.11 |
| Change From Baseline at Week 1 | -2.0 ± 0.08 | -2.0 ± 0.11 |
| Change From Baseline at Week 2 | -2.0 ± 0.08 | -2.1 ± 0.11 |
| Change From Baseline at Month 1 | -2.0 ± 0.08 | -2.1 ± 0.11 |
| Change From Baseline at Month 3 | -1.8 ± 0.08 | -2.2 ± 0.11 |
| Change From Baseline at Month 6 | -1.7 ± 0.08 | -2.0 ± 0.11 |
| Change From Baseline at Month 9 | -1.7 ± 0.08 | -2.0 ± 0.11 |
| Change From Baseline at Month 12 | -1.7 ± 0.08 | -2.0 ± 0.11 |
IOP is a measurement of the fluid pressure inside the eye.
| mm Hg | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change From Baseline in Mean IOP at Month 12 | -8.25 ± 0.701 | -11.02 ± 1.009 |
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.
| medications | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12 | -1.7 ± 0.08 | -2.0 ± 0.11 |
IOP is a measurement of the fluid pressure inside the eye.
| mm Hg | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg | -2.83 ± 1.281 | -4.61 ± 1.801 |
Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
| medications | XEN-45 Gel Stent | 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 | -1.8 ± 0.15 | -2.1 ± 0.20 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| IOP Value of ≤18 mm Hg | 68.4 | 84.1 |
| IOP Value of ≤17 mm Hg | 64.2 | 79.5 |
| IOP Value of ≤16 mm Hg | 62.1 | 79.5 |
| IOP Value of ≤15 mm Hg | 55.8 | 72.7 |
| IOP Value of ≤14 mm Hg | 50.5 | 63.6 |
| IOP Value of ≤13 mm Hg | 36.8 | 56.8 |
| IOP Value of ≤12 mm Hg | 30.5 | 43.2 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| ≥25% IOP Reduction | 60.0 | 63.6 |
| ≥30% IOP Reduction | 48.4 | 61.4 |
| ≥35% IOP Reduction | 41.1 | 61.4 |
| ≥40% IOP Reduction | 35.8 | 54.5 |
| ≥45% IOP Reduction | 25.3 | 43.2 |
| ≥50% IOP Reduction | 22.1 | 43.2 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| IOP Target ≤18 mm Hg | 61.1 | 72.7 |
| IOP Target ≤17 mm Hg | 58.9 | 70.5 |
| IOP Target ≤16 mm Hg | 56.8 | 70.5 |
| IOP Target ≤15 mm Hg | 55.8 | 70.5 |
| IOP Target ≤14 mm Hg | 50.5 | 61.4 |
| IOP Target ≤13 mm Hg | 36.8 | 54.5 |
| IOP Target ≤12 mm Hg | 30.5 | 43.2 |
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 participants | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Participants With Needlings Performed | 23.2 | 18.2 |
Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye.
| needlings | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Mean Number of Needlings Per Eye | 1.7 ± 1.03 | 1.4 ± 0.74 |
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 | XEN-45 Gel Stent | 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 | 87.5 | 85.7 |
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 eyes | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings | 42.9 | 75.0 |
Antifibrotic use included mitomycin-C (MMC) which was standardized for both groups and administered according to physician training and practice.
| percentage of participants | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Participants With Antifibrotic Use During Needling | 16.8 | 15.9 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Participants Achieving Complete Success at Month 12 | 44.2 | 59.1 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Participants Achieving Qualified Success at Month 12 | 62.1 | 72.7 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| IOP Target ≤18 mm Hg | 79.7 | 87.1 |
| IOP Target ≤17 mm Hg | 74.6 | 87.1 |
| IOP Target ≤16 mm Hg | 71.2 | 87.1 |
| IOP Target ≤15 mm Hg | 64.4 | 83.9 |
| IOP Target ≤14 mm Hg | 59.3 | 80.6 |
| IOP Target ≤13 mm Hg | 47.5 | 71.0 |
| IOP Target ≤12 mm Hg | 37.3 | 58.1 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| ≥25% IOP Reduction | 67.8 | 77.4 |
| ≥30% IOP Reduction | 57.6 | 77.4 |
| ≥35% IOP Reduction | 50.8 | 77.4 |
| ≥40% IOP Reduction | 44.1 | 67.7 |
| ≥45% IOP Reduction | 30.5 | 58.1 |
| ≥50% IOP Reduction | 27.1 | 58.1 |
Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice.
| percentage of participants | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use | 98.9 | 97.7 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Before Procedure | 37.9 | 56.8 |
| After Procedure | 61.1 | 40.9 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Injection | 98.9 | 84.1 |
| Other | 0 | 13.6 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| 0.1 | 50.5 | 34.1 |
| 0.2 | 47.4 | 56.8 |
| Other | 1.1 | 2.3 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| 0.2 | 34.7 | 36.4 |
| 0.4 | 64.2 | 56.8 |
| Other | 0 | 0 |
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.
| percentage of participants | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| 40 | 97.9 | 93.2 |
| Other | 1.1 | 0 |
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.
| Log10 (Lines) | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change From Baseline at Day 1 | -1.4 ± 0.20 | -2.5 ± 0.29 |
| Change From Baseline at Week 1 | -1.2 ± 0.20 | -2.4 ± 0.29 |
| Change From Baseline at Week 2 | -1.1 ± 0.20 | -1.6 ± 0.29 |
| Change From Baseline at Month 1 | -0.6 ± 0.20 | -1.1 ± 0.30 |
| Change From Baseline at Month 3 | -0.4 ± 0.20 | -0.5 ± 0.30 |
| Change From Baseline at Month 6 | -0.4 ± 0.21 | -0.4 ± 0.30 |
| Change From Baseline at Month 9 | -0.4 ± 0.21 | -1.0 ± 0.30 |
| Change From Baseline at Month 12 | -0.1 ± 0.21 | -0.8 ± 0.31 |
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.
| logMAR | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change From Baseline at Month 1 | 0.05 ± 0.015 | 0.10 ± 0.022 |
| Change From Baseline at Month 3 | 0.04 ± 0.016 | 0.05 ± 0.022 |
| Change From Baseline at Month 6 | 0.04 ± 0.016 | 0.04 ± 0.022 |
| Change From Baseline at Month 12 | 0.01 ± 0.016 | 0.07 ± 0.022 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
| diopters | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change From Baseline at Week 1 | 0.057 ± 0.1861 | 0.619 ± 0.2639 |
| Change From Baseline at Month 1 | 0.187 ± 0.1931 | 0.326 ± 0.2741 |
| Change From Baseline at Month 12 | 0.106 ± 0.1976 | 0.558 ± 0.2860 |
| millimeter | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change from Baseline at Day 1 | -0.183 ± 0.1295 | -0.182 ± 0.1553 |
| Change from Baseline at Week 2 | -0.206 ± 0.1195 | -0.427 ± 0.1732 |
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.
| diopter | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| K1, Change from Baseline at Day 1 | -0.103 ± 0.2195 | -0.446 ± 0.2512 |
| K1, Change from Baseline at Week 2 | 0.156 ± 0.1973 | -0.105 ± 0.2618 |
| K2, Change from Baseline at Day 1 | 0.373 ± 0.2947 | 0.783 ± 0.3342 |
| K2, Change from Baseline at Week 2 | 0.152 ± 0.2626 | 0.640 ± 0.3499 |
| Delta D, Change from Baseline at Day 1 | 0.514 ± 0.2967 | 1.279 ± 0.3372 |
| Delta D, Change from Baseline at Week 2 | 0.087 ± 0.2636 | 0.664 ± 0.3527 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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 participants | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Participants With Clinical Hypotony | 23.2 | 50.0 |
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 eyes | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment | 13.7 | 29.5 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Anterior Chamber Bleeding | 1.1 | 4.5 |
| Other | 1.1 | 2.3 |
| Conjunctival Buttonhole | 0.0 | 2.3 |
| Iris Damage | 0.0 | 2.3 |
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 | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs) | 66.3 | 86.4 |
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.
| percentage of participants | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Worsening | 36.84 | 56.82 |
| No Change | 63.16 | 40.91 |
| Missing | 0.0 | 2.27 |
Pachymetry was measured as average central corneal thickness (microns/micrometer) change from Baseline.
| micrometer (µm) | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Pachymetry Based on Change From Baseline In Average Central Corneal Thickness | -2.0 ± 21.41 | 6.4 ± 12.44 |
All visual field examination data were collected and reported as mean deviation by Humphrey machine.
| decibel (dB) | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Change From Baseline in Visual Field Examinations Analyzed by Machine Type | -0.051 ± 4.5578 | -0.356 ± 3.0171 |
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
| percentage of participants | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| TEAEs | 74.7 | 93.2 |
| TESAEs | 9.5 | 4.5 |
| TEADEs | 0.0 | 0.0 |
| TESADEs | 0.0 | 0.0 |
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.
| score on a scale | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Local Eye Symptoms Score | -3.328 ± 2.5560 | -0.297 ± 3.4928 |
| Vision Function Problem Score | -3.064 ± 2.6759 | 7.443 ± 3.6965 |
| Total Bothersome Score | -3.160 ± 2.3564 | 4.368 ± 3.2737 |
| Local Eye Symptoms Frequency Score | -0.6 ± 0.25 | -0.1 ± 0.34 |
| Vision Function Problem Frequency Score | -0.7 ± 0.37 | 1.0 ± 0.51 |
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.
| percentage of participants | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| Not at all | 1.1 | 2.3 |
| Somewhat | 4.2 | 9.1 |
| Moderately so | 4.2 | 4.5 |
| Mostly | 6.3 | 20.5 |
| Completely | 41.1 | 31.8 |
| Missing | 43.2 | 31.8 |
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.
| percent change | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health | -0.994 ± 12.4333 | 7.309 ± 10.3287 |
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.
| percent change | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health | -3.1 ± 5.18 | 10.8 ± 6.53 |
Collected over Median follow-up of 366.0 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| XEN-45 Gel Stent | 3/107 (2.8%) | 9/95 (9.5%) | 59/95 (62.1%) |
| Trabeculectomy | 1/51 (2%) | 2/44 (4.5%) | 38/44 (86.4%) |
| Event | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| FALLInjury, poisoning and procedural complications | 0/95 | 1/44 |
| ACUTE RESPIRATORY DISTRESS SYNDROMERespiratory, thoracic and mediastinal disorders | 0/95 | 1/44 |
| CORONA VIRUS INFECTIONInfections and infestations | 2/95 | 0/44 |
| CARDIAC ARRESTCardiac disorders | 1/95 | 0/44 |
| VISUAL ACUITY REDUCEDEye disorders | 1/95 | 0/44 |
| ENDOPHTHALMITISInfections and infestations | 1/95 | 0/44 |
| PERIORBITAL CELLULITISInfections and infestations | 1/95 | 0/44 |
| PNEUMONIAInfections and infestations | 1/95 | 0/44 |
| SEPSISInfections and infestations | 1/95 | 0/44 |
| INTRAOCULAR PRESSURE INCREASEDInvestigations | 1/95 | 0/44 |
| Event | XEN-45 Gel Stent | Trabeculectomy |
|---|---|---|
| VISUAL ACUITY REDUCEDEye disorders | 36/95 | 24/44 |
| HYPOTONY OF EYEEye disorders | 22/95 | 22/44 |
| INTRAOCULAR PRESSURE INCREASEDInvestigations | 19/95 | 5/44 |
| CONJUNCTIVAL FILTERING BLEB LEAKInjury, poisoning and procedural complications | 0/95 | 7/44 |
| CHOROIDAL EFFUSIONEye disorders | 2/95 | 4/44 |
| DRY EYEEye disorders | 3/95 | 3/44 |
| GLAUCOMAEye disorders | 0/95 | 3/44 |
| PUNCTATE KERATITISEye disorders | 2/95 | 3/44 |
| HYPHAEMAInjury, poisoning and procedural complications | 6/95 | 3/44 |
Intent-to-treat (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.
| Age, Continuous(years) | XEN-45 Gel Stent | Trabeculectomy | Total |
|---|---|---|---|
| Mean | 69.5 ± 9.64 | 69.4 ± 9.72 | 69.5 ± 9.63 |
| Sex: Female, Male(Participants) | XEN-45 Gel Stent | Trabeculectomy | Total |
|---|---|---|---|
| Female | 41 | 19 | 60 |
| Male | 54 | 25 | 79 |
| Race/Ethnicity, Customized(Participants) | XEN-45 Gel Stent | Trabeculectomy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 18 | 10 | 28 |
| Asian | 2 | 0 | 2 |
| Black or African American | 14 | 8 | 22 |
| White or Caucasian | 61 | 26 | 87 |
| Race/Ethnicity, Customized(Participants) | XEN-45 Gel Stent | Trabeculectomy | Total |
|---|---|---|---|
| Ethnicity | — | — | 0 |
| Study Eye Intraocular Pressure (IOP)(millimetre of mercury (mm Hg)) | XEN-45 Gel Stent | Trabeculectomy | Total |
|---|---|---|---|
| Mean | 23.13 ± 5.817 | 22.56 ± 5.653 | 22.95 ± 5.751 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Allergan