Trial Outcomes & Findings for Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants (NCT NCT02006693)

NCT ID: NCT02006693

Last Updated: 2019-04-22

Results Overview

IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

199 participants

Primary outcome timeframe

Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)

Results posted on

2019-04-22

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	XEN® Gel Stent The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.	XEN® Gel Stent With Cataract Surgery The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Overall Study STARTED	112 120	87 98
Overall Study COMPLETED	84 91	74 83
Overall Study NOT COMPLETED	28 29	13 15

Reasons for withdrawal

Reasons for withdrawal
Measure	XEN® Gel Stent The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.	XEN® Gel Stent With Cataract Surgery The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Overall Study No Reason Specified	6	8
Overall Study Another Glaucoma-related Surgery	12	1
Overall Study XEN Implant Explantation	0	1
Overall Study Death	2	2
Overall Study Lost to Follow-up	4	1
Overall Study Patient Decision	4	0

Baseline Characteristics

Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XEN® Gel Stent n=114 Eyes The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.	XEN® Gel Stent With Cataract Surgery n=88 Eyes The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.	Total n=202 Eyes Total of all reporting groups
Age, Continuous	68.3 years STANDARD_DEVIATION 11.7 • n=5 Participants	76.5 years STANDARD_DEVIATION 6.1 • n=7 Participants	71.8 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	40 Participants n=7 Participants	95 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	39 Participants n=7 Participants	90 Participants n=5 Participants
Race/Ethnicity, Customized White	103 Participants n=5 Participants	75 Participants n=7 Participants	178 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)

Population: mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.

Outcome measures

Outcome measures
Measure	XEN® Gel Stent n=114 eyes The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.	XEN® Gel Stent With Cataract Surgery n=88 eyes The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 Baseline (preoperation)	21.7 mmHg Standard Deviation 3.76	21.0 mmHg Standard Deviation 3.39
Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 Change from Baseline to Month 12	-6.6 mmHg Standard Deviation 5.64	-6.4 mmHg Standard Deviation 4.96

PRIMARY outcome

Timeframe: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)

The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	XEN® Gel Stent n=114 eyes The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.	XEN® Gel Stent With Cataract Surgery n=88 eyes The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12 Baseline (preoperation)	2.7 medications Standard Deviation 0.93	2.5 medications Standard Deviation 0.88
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12 Change from Baseline to Month 12	-1.8 medications Standard Deviation 1.31	-1.6 medications Standard Deviation 1.17

PRIMARY outcome

Timeframe: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)

Outcome measures

Outcome measures
Measure	XEN® Gel Stent n=114 eyes The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.	XEN® Gel Stent With Cataract Surgery n=88 eyes The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Mean Change From Baseline in IOP in the Study Eyes to Month 24 Baseline (preoperation)	21.7 mmHg Standard Deviation 3.76	21.0 mmHg Standard Deviation 3.39
Mean Change From Baseline in IOP in the Study Eyes to Month 24 Change from Baseline to Month 24	-6.4 mmHg Standard Deviation 5.18	-5.9 mmHg Standard Deviation 4.60

PRIMARY outcome

Timeframe: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)

The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	XEN® Gel Stent n=114 eyes The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.	XEN® Gel Stent With Cataract Surgery n=88 eyes The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24 Baseline (preoperation)	2.7 medications Standard Deviation 0.93	2.5 medications Standard Deviation 0.88
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24 Change from Baseline to Month 24	-1.5 medications Standard Deviation 1.54	-1.5 medications Standard Deviation 1.22

Adverse Events

XEN® Gel Stent

Serious events: 12 serious events

Other events: 14 other events

Deaths: 2 deaths

XEN® Gel Stent With Cataract Surgery

Serious events: 6 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	XEN® Gel Stent n=120 participants at risk The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.	XEN® Gel Stent With Cataract Surgery n=98 participants at risk The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Injury, poisoning and procedural complications Hyphema	6.7% 8/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	2.0% 2/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Surgical and medical procedures Trabeculectomy	5.8% 7/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	1.0% 1/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Surgical and medical procedures YAG (yttrium-aluminum-garnet) laser surgery	0.00% 0/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	5.1% 5/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER

Measure	XEN® Gel Stent n=120 participants at risk The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.	XEN® Gel Stent With Cataract Surgery n=98 participants at risk The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Cardiac disorders Cardiac arrest	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Cardiac disorders Heart attack	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Eye disorders Cataract aggravated	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Eye disorders Retinal disorder	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
General disorders Implant site dehiscence	0.00% 0/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	1.0% 1/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Hepatobiliary disorders Decompensated cirrhosis	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Infections and infestations Endophthalmitis	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Injury, poisoning and procedural complications Broken hip	0.00% 0/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	2.0% 2/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Investigations Intraocular pressure high	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Investigations Intraocular pressure high - fellow eye	0.00% 0/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	1.0% 1/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Metabolism and nutrition disorders Hyponatremia	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	2.0% 2/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kidney tumor	1.7% 2/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral cancer stage unspecified	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Stomach cancer	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Surgical and medical procedures Trabeculectomy	0.83% 1/120 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.	0.00% 0/98 • Up to 26 Months The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.