18 and older, any sex, with Glaucoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified CaveatsPrimary· 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.
Group
Value
95% CI
XEN-45 Gel Stent
62.1
Trabeculectomy
68.2
Mean IOP Over TimeSecondary· 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.
Day 1
Group
Value
95% CI
XEN-45 Gel Stent
9.25
± 4.710
Trabeculectomy
15.00
± 13.025
Week 1
Group
Value
95% CI
XEN-45 Gel Stent
11.27
± 6.864
Trabeculectomy
11.48
± 7.323
Week 2
Group
Value
95% CI
XEN-45 Gel Stent
13.64
± 8.363
Trabeculectomy
11.53
± 5.503
Month 1
Group
Value
95% CI
XEN-45 Gel Stent
13.72
± 6.315
Trabeculectomy
11.45
± 5.645
Month 3
Group
Value
95% CI
XEN-45 Gel Stent
16.46
± 7.407
Trabeculectomy
11.59
± 4.672
Month 6
Group
Value
95% CI
XEN-45 Gel Stent
14.86
± 4.228
Trabeculectomy
11.72
± 5.242
Month 9
Group
Value
95% CI
XEN-45 Gel Stent
14.57
± 4.221
Trabeculectomy
11.02
± 3.535
Month 12
Group
Value
95% CI
XEN-45 Gel Stent
14.43
± 4.060
Trabeculectomy
11.83
± 3.525
Change From Baseline in Mean IOP Over TimeSecondary· 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 at Day 1
Group
Value
95% CI
XEN-45 Gel Stent
-13.63
± 0.645
Trabeculectomy
-7.82
± 0.958
Change From Baseline at Week 1
Group
Value
95% CI
XEN-45 Gel Stent
-11.56
± 0.660
Trabeculectomy
-11.34
± 0.958
Change From Baseline at Week 2
Group
Value
95% CI
XEN-45 Gel Stent
-9.26
± 0.657
Trabeculectomy
-11.29
± 0.958
Change From Baseline at Month 1
Group
Value
95% CI
XEN-45 Gel Stent
-9.15
± 0.648
Trabeculectomy
-11.37
± 0.958
Change From Baseline at Month 3
Group
Value
95% CI
XEN-45 Gel Stent
-6.35
± 0.663
Trabeculectomy
-11.09
± 0.977
Change From Baseline at Month 6
Group
Value
95% CI
XEN-45 Gel Stent
-7.94
± 0.690
Trabeculectomy
-10.95
± 0.978
Change From Baseline at Month 9
Group
Value
95% CI
XEN-45 Gel Stent
-8.19
± 0.690
Trabeculectomy
-11.72
± 0.978
Change From Baseline at Month 12
Group
Value
95% CI
XEN-45 Gel Stent
-8.25
± 0.701
Trabeculectomy
-11.02
± 1.009
Mean Number of Topical IOP-Lowering Medications Over TimeSecondary· 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.
Day 1
Group
Value
95% CI
XEN-45 Gel Stent
0.2
± 0.51
Trabeculectomy
0.3
± 0.53
Week 1
Group
Value
95% CI
XEN-45 Gel Stent
0.3
± 0.77
Trabeculectomy
0.3
± 0.73
Week 2
Group
Value
95% CI
XEN-45 Gel Stent
0.3
± 0.64
Trabeculectomy
0.2
± 0.53
Month 1
Group
Value
95% CI
XEN-45 Gel Stent
0.3
± 0.75
Trabeculectomy
0.1
± 0.52
Month 3
Group
Value
95% CI
XEN-45 Gel Stent
0.5
± 0.89
Trabeculectomy
0.1
± 0.26
Month 6
Group
Value
95% CI
XEN-45 Gel Stent
0.6
± 0.96
Trabeculectomy
0.2
± 0.58
Month 9
Group
Value
95% CI
XEN-45 Gel Stent
0.6
± 1.09
Trabeculectomy
0.2
± 0.49
Month 12
Group
Value
95% CI
XEN-45 Gel Stent
0.6
± 0.95
Trabeculectomy
0.3
± 0.50
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over TimeSecondary· 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 at Day 1
Group
Value
95% CI
XEN-45 Gel Stent
-2.1
± 0.08
Trabeculectomy
-2.0
± 0.11
Change From Baseline at Week 1
Group
Value
95% CI
XEN-45 Gel Stent
-2.0
± 0.08
Trabeculectomy
-2.0
± 0.11
Change From Baseline at Week 2
Group
Value
95% CI
XEN-45 Gel Stent
-2.0
± 0.08
Trabeculectomy
-2.1
± 0.11
Change From Baseline at Month 1
Group
Value
95% CI
XEN-45 Gel Stent
-2.0
± 0.08
Trabeculectomy
-2.1
± 0.11
Change From Baseline at Month 3
Group
Value
95% CI
XEN-45 Gel Stent
-1.8
± 0.08
Trabeculectomy
-2.2
± 0.11
Change From Baseline at Month 6
Group
Value
95% CI
XEN-45 Gel Stent
-1.7
± 0.08
Trabeculectomy
-2.0
± 0.11
Change From Baseline at Month 9
Group
Value
95% CI
XEN-45 Gel Stent
-1.7
± 0.08
Trabeculectomy
-2.0
± 0.11
Change From Baseline at Month 12
Group
Value
95% CI
XEN-45 Gel Stent
-1.7
± 0.08
Trabeculectomy
-2.0
± 0.11
Change From Baseline in Mean IOP at Month 12Secondary· Baseline (Preoperative) and Month 12
IOP is a measurement of the fluid pressure inside the eye.
Group
Value
95% CI
XEN-45 Gel Stent
-8.25
± 0.701
Trabeculectomy
-11.02
± 1.009
Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12Secondary· 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.
Group
Value
95% CI
XEN-45 Gel Stent
-1.7
± 0.08
Trabeculectomy
-2.0
± 0.11
Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm HgSecondary· Baseline (Preoperative) and Month 12
IOP is a measurement of the fluid pressure inside the eye.
Group
Value
95% CI
XEN-45 Gel Stent
-2.83
± 1.281
Trabeculectomy
-4.61
± 1.801
Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm HgSecondary· 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.
Group
Value
95% CI
XEN-45 Gel Stent
-1.8
± 0.15
Trabeculectomy
-2.1
± 0.20
Percentage of Participants Achieving Specific IOP Targets at Month 12Secondary· 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.
IOP Value of ≤18 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
68.4
Trabeculectomy
84.1
IOP Value of ≤17 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
64.2
Trabeculectomy
79.5
IOP Value of ≤16 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
62.1
Trabeculectomy
79.5
IOP Value of ≤15 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
55.8
Trabeculectomy
72.7
IOP Value of ≤14 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
50.5
Trabeculectomy
63.6
IOP Value of ≤13 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
36.8
Trabeculectomy
56.8
IOP Value of ≤12 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
30.5
Trabeculectomy
43.2
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12Secondary· 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.
≥25% IOP Reduction
Group
Value
95% CI
XEN-45 Gel Stent
60.0
Trabeculectomy
63.6
≥30% IOP Reduction
Group
Value
95% CI
XEN-45 Gel Stent
48.4
Trabeculectomy
61.4
≥35% IOP Reduction
Group
Value
95% CI
XEN-45 Gel Stent
41.1
Trabeculectomy
61.4
≥40% IOP Reduction
Group
Value
95% CI
XEN-45 Gel Stent
35.8
Trabeculectomy
54.5
≥45% IOP Reduction
Group
Value
95% CI
XEN-45 Gel Stent
25.3
Trabeculectomy
43.2
≥50% IOP Reduction
Group
Value
95% CI
XEN-45 Gel Stent
22.1
Trabeculectomy
43.2
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 12Secondary· 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.
IOP Target ≤18 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
61.1
Trabeculectomy
72.7
IOP Target ≤17 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
58.9
Trabeculectomy
70.5
IOP Target ≤16 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
56.8
Trabeculectomy
70.5
IOP Target ≤15 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
55.8
Trabeculectomy
70.5
IOP Target ≤14 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
50.5
Trabeculectomy
61.4
IOP Target ≤13 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
36.8
Trabeculectomy
54.5
IOP Target ≤12 mm Hg
Group
Value
95% CI
XEN-45 Gel Stent
30.5
Trabeculectomy
43.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Median follow-up of 366.0 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 21 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03654885.