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

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ClinicalTrials.gov Identifier: NCT02006693
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
AqueSys, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Open Angle Glaucoma
Interventions Device: XEN® Gel Stent
Procedure: Cataract Surgery
Enrollment 199
Recruitment Details  
Pre-assignment Details  
Arm/Group Title XEN® Gel Stent XEN® Gel Stent With Cataract Surgery
Hide Arm/Group Description The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Period Title: Overall Study
Number of participants Number of units (Eyes) Number of participants Number of units (Eyes)
Started 112 120 87 98
Completed 84 91 74 83
Not Completed 28 29 13 15
Reason Not Completed
No Reason Specified             6                         8            
Another Glaucoma-related Surgery             12                         1            
XEN Implant Explantation             0                         1            
Death             2                         2            
Lost to Follow-up             4                         1            
Patient Decision             4                         0            
Arm/Group Title XEN® Gel Stent XEN® Gel Stent With Cataract Surgery Total
Hide Arm/Group Description The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. Total of all reporting groups
Overall Number of Baseline Participants 106 79 185
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
114 88 202
Hide Baseline Analysis Population Description
Modified Intent-to-Treat (mITT) Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 79 participants 185 participants
68.3  (11.7) 76.5  (6.1) 71.8  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 79 participants 185 participants
Female
55
  51.9%
40
  50.6%
95
  51.4%
Male
51
  48.1%
39
  49.4%
90
  48.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 79 participants 185 participants
White
103
  97.2%
75
  94.9%
178
  96.2%
Black or African American
2
   1.9%
1
   1.3%
3
   1.6%
Asian
1
   0.9%
3
   3.8%
4
   2.2%
1.Primary Outcome
Title Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12
Hide Description 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.
Time Frame Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title XEN® Gel Stent XEN® Gel Stent With Cataract Surgery
Hide Arm/Group Description:
The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Overall Number of Participants Analyzed 106 79
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
114 88
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (preoperation) Number Analyzed 114 eyes 88 eyes
21.7  (3.76) 21.0  (3.39)
Change from Baseline to Month 12 Number Analyzed 97 eyes 81 eyes
-6.6  (5.64) -6.4  (4.96)
2.Primary Outcome
Title Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
Hide Description 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.
Time Frame Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title XEN® Gel Stent XEN® Gel Stent With Cataract Surgery
Hide Arm/Group Description:
The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Overall Number of Participants Analyzed 106 79
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
114 88
Mean (Standard Deviation)
Unit of Measure: medications
Baseline (preoperation) Number Analyzed 114 eyes 88 eyes
2.7  (0.93) 2.5  (0.88)
Change from Baseline to Month 12 Number Analyzed 97 eyes 81 eyes
-1.8  (1.31) -1.6  (1.17)
3.Primary Outcome
Title Mean Change From Baseline in IOP in the Study Eyes to Month 24
Hide Description 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.
Time Frame Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title XEN® Gel Stent XEN® Gel Stent With Cataract Surgery
Hide Arm/Group Description:
The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Overall Number of Participants Analyzed 106 79
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
114 88
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (preoperation) Number Analyzed 114 eyes 88 eyes
21.7  (3.76) 21.0  (3.39)
Change from Baseline to Month 24 Number Analyzed 86 eyes 75 eyes
-6.4  (5.18) -5.9  (4.60)
4.Primary Outcome
Title Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
Hide Description 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.
Time Frame Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title XEN® Gel Stent XEN® Gel Stent With Cataract Surgery
Hide Arm/Group Description:
The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Overall Number of Participants Analyzed 106 79
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
114 88
Mean (Standard Deviation)
Unit of Measure: medications
Baseline (preoperation) Number Analyzed 114 eyes 88 eyes
2.7  (0.93) 2.5  (0.88)
Change from Baseline to Month 24 Number Analyzed 86 eyes 75 eyes
-1.5  (1.54) -1.5  (1.22)
Time Frame Up to 26 Months
Adverse Event Reporting Description 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.
 
Arm/Group Title XEN® Gel Stent XEN® Gel Stent With Cataract Surgery
Hide Arm/Group Description The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
All-Cause Mortality
XEN® Gel Stent XEN® Gel Stent With Cataract Surgery
Affected / at Risk (%) Affected / at Risk (%)
Total   2/112 (1.79%)   2/87 (2.30%) 
Hide Serious Adverse Events
XEN® Gel Stent XEN® Gel Stent With Cataract Surgery
Affected / at Risk (%) Affected / at Risk (%)
Total   12/120 (10.00%)   6/98 (6.12%) 
Cardiac disorders     
Cardiac arrest  1  1/120 (0.83%)  0/98 (0.00%) 
Heart attack  1  1/120 (0.83%)  0/98 (0.00%) 
Eye disorders     
Cataract aggravated  1  1/120 (0.83%)  0/98 (0.00%) 
Retinal disorder  1  1/120 (0.83%)  0/98 (0.00%) 
General disorders     
Implant site dehiscence  1  0/120 (0.00%)  1/98 (1.02%) 
Hepatobiliary disorders     
Decompensated cirrhosis  1  1/120 (0.83%)  0/98 (0.00%) 
Infections and infestations     
Endophthalmitis  1  1/120 (0.83%)  0/98 (0.00%) 
Injury, poisoning and procedural complications     
Broken hip  1  0/120 (0.00%)  2/98 (2.04%) 
Investigations     
Intraocular pressure high  1  1/120 (0.83%)  0/98 (0.00%) 
Intraocular pressure high - fellow eye  1  0/120 (0.00%)  1/98 (1.02%) 
Metabolism and nutrition disorders     
Hyponatremia  1  1/120 (0.83%)  0/98 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatocellular carcinoma  1  0/120 (0.00%)  2/98 (2.04%) 
Kidney tumor  1  2/120 (1.67%)  0/98 (0.00%) 
Oral cancer stage unspecified  1  1/120 (0.83%)  0/98 (0.00%) 
Stomach cancer  1  1/120 (0.83%)  0/98 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  1/120 (0.83%)  0/98 (0.00%) 
Surgical and medical procedures     
Trabeculectomy  1  1/120 (0.83%)  0/98 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
XEN® Gel Stent XEN® Gel Stent With Cataract Surgery
Affected / at Risk (%) Affected / at Risk (%)
Total   14/120 (11.67%)   8/98 (8.16%) 
Injury, poisoning and procedural complications     
Hyphema  1  8/120 (6.67%)  2/98 (2.04%) 
Surgical and medical procedures     
Trabeculectomy  1  7/120 (5.83%)  1/98 (1.02%) 
YAG (yttrium-aluminum-garnet) laser surgery  1  0/120 (0.00%)  5/98 (5.10%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: AqueSys, Inc.
ClinicalTrials.gov Identifier: NCT02006693    
Other Study ID Numbers: MS-001
First Submitted: December 2, 2013
First Posted: December 10, 2013
Results First Submitted: June 29, 2018
Results First Posted: April 22, 2019
Last Update Posted: April 22, 2019