Trial Outcomes & Findings for Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes (NCT NCT02023242)

NCT ID: NCT02023242

Last Updated: 2019-12-10

Results Overview

Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 12 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 152 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-12-10

Participant Flow

Patients were screened and enrolled at 12 investigational sites located outside of the United States

152 patients were randomized

Participant milestones

Measure	Hydrus Microstent Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass Subjects underwent 2 iStents implantation
Overall Study STARTED	75	77
Overall Study COMPLETED	72	75
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Hydrus Microstent Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass Subjects underwent 2 iStents implantation
Overall Study Lost to Follow-up	3	1
Overall Study Death	0	1

Baseline Characteristics

Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes

Baseline characteristics by cohort

Measure	Hydrus Microstent n=75 Participants Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass n=77 Participants Subjects underwent 2 iStents implantation	Total n=152 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 10.3 • n=93 Participants	66.5 years STANDARD_DEVIATION 9.5 • n=4 Participants	67.0 years STANDARD_DEVIATION 9.9 • n=27 Participants
Sex: Female, Male Female	41 Participants n=93 Participants	45 Participants n=4 Participants	86 Participants n=27 Participants
Sex: Female, Male Male	34 Participants n=93 Participants	32 Participants n=4 Participants	66 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian/White European	49 Participants n=93 Participants	49 Participants n=4 Participants	98 Participants n=27 Participants
Race/Ethnicity, Customized Black or African Descent	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Asian	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Race/Ethnicity, Customized Native North American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic/Latino/Central & So American Origin	14 Participants n=93 Participants	13 Participants n=4 Participants	27 Participants n=27 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Intent-to-Treat (ITT)

Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 12 months

Outcome measures

Measure	Hydrus Microstent n=73 Participants Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass n=75 Participants Subjects underwent 2 iStents implantation
Unmedicated IOP </= 19 mmHg at 12 Months	34.2 percentage of participants	13.3 percentage of participants

SECONDARY outcome

Timeframe: 12 & 24 Months

Population: Intent-to-Treat (ITT). Number of Participants Analyzed at 24 Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up

The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months

Outcome measures

Measure	Hydrus Microstent n=73 Participants Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass n=75 Participants Subjects underwent 2 iStents implantation
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months 12 Months	46.6 percentage of participants	24.0 percentage of participants
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months 24 Months	38.0 percentage of participants	18.7 percentage of participants

SECONDARY outcome

Timeframe: 12 & 24 Months

Population: Intent-to-Treat (ITT). Number of Participants Analyzed at 24 Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up

The mean medication use at 12 and 24 months

Outcome measures

Measure	Hydrus Microstent n=73 Participants Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass n=75 Participants Subjects underwent 2 iStents implantation
Mean Medication Use at 12 and 24 Months 12 Months	0.99 number of medications Standard Deviation 1.07	1.69 number of medications Standard Deviation 1.37
Mean Medication Use at 12 and 24 Months 24 Months	1.23 number of medications Standard Deviation 1.15	1.91 number of medications Standard Deviation 1.36

SECONDARY outcome

Timeframe: 24 Months

Population: Intent-to-Treat (ITT). Number of Participants Analyzed at 24Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up

Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 24 months

Outcome measures

Measure	Hydrus Microstent n=71 Participants Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass n=75 Participants Subjects underwent 2 iStents implantation
Unmedicated IOP </= 19 mmHg at 24 Months	23.9 percentage of participants	13.3 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-Treat (ITT)

Percentage of subjects with IOP </= 18 mmHg and without the use of ocular hypotensive medications at 12 months

Outcome measures

Measure	Hydrus Microstent n=73 Participants Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass n=75 Participants Subjects underwent 2 iStents implantation
Unmedicated IOP </= 18 mmHg at 12 Months	30.1 percentage of participants	9.3 percentage of participants

Adverse Events

Hydrus Microstent

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

iStent Trabecular Micro Bypass

Serious events: 14 serious events

Other events: 23 other events

Deaths: 1 deaths

Serious adverse events

Measure	Hydrus Microstent n=75 participants at risk Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass n=77 participants at risk Subjects underwent 2 iStents implantation
Eye disorders BCVA loss >/= 2 lines ETDRS >/= 3 months	0.00% 0/75 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	2.6% 2/77 • Number of events 2 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders Cataract	4.0% 3/75 • Number of events 3 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	2.6% 2/77 • Number of events 2 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders IOP Increase	0.00% 0/75 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	1.3% 1/77 • Number of events 1 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders IOP increase (>=10 mmHg than BL >= 1M)	0.00% 0/75 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	1.3% 1/77 • Number of events 1 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders Inflammation lasting >1M	0.00% 0/75 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	1.3% 1/77 • Number of events 1 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders Proliferative Diabetic Retinopathy	1.3% 1/75 • Number of events 1 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	0.00% 0/77 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders Uncontrolled Glaucoma	0.00% 0/75 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	9.1% 7/77 • Number of events 8 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders Wet Age Related Macular Degeneration	4.0% 3/75 • Number of events 3 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	0.00% 0/77 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.

Other adverse events

Measure	Hydrus Microstent n=75 participants at risk Subjects underwent 1 Hydrus implantation	iStent Trabecular Micro Bypass n=77 participants at risk Subjects underwent 2 iStents implantation
Eye disorders BCVA loss >= 2 lines ETDRS >= 3M (Post-Operative)	6.7% 5/75 • Number of events 5 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	11.7% 9/77 • Number of events 9 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders Device Obstruction (Post-Operative)	8.0% 6/75 • Number of events 6 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	13.0% 10/77 • Number of events 10 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders PAS with Device Obstruction (Post-Operative)	6.7% 5/75 • Number of events 5 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	1.3% 1/77 • Number of events 1 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders PAS without Device Obstruction (Post-Operative)	10.7% 8/75 • Number of events 8 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	3.9% 3/77 • Number of events 3 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
Eye disorders Device Malposition (Intraoperative)	2.7% 2/75 • Number of events 2 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.	6.5% 5/77 • Number of events 5 • 24 Months An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.

Additional Information

Richard Hope

Ivantis, Inc.

Phone: 949-333-1310

Email: rhope@ivantisinc.com

Results disclosure agreements

• Principal investigator is a sponsor employee "If the Clinical Investigation is multi-centered, any publication based on the results obtained at the Investigation Site (or a group of sites) shall not be made before the first multi-center publication."
• Publication restrictions are in place

Restriction type: OTHER