Trial Outcomes & Findings for Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy (NCT NCT01166659)

NCT ID: NCT01166659

Last Updated: 2017-05-15

Results Overview

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: Baseline; Month 12 postoperative
• Results posted on: 2017-05-15

Participant Flow

Participants were enrolled at 7 investigational sites in Germany, Bulgaria, Spain and Austria.

This reporting group includes all treated participants.

Participant milestones

Measure	CyPass Micro-Stent Subjects received the CyPass Micro-Stent
Overall Study STARTED	48
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	CyPass Micro-Stent Subjects received the CyPass Micro-Stent
Overall Study Subject Decision	8
Overall Study Investigator Decision	2
Overall Study Death	1
Overall Study Lost to Follow-up	1
Overall Study Study Closed at Site	1

Baseline Characteristics

Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy

Baseline characteristics by cohort

Measure	CyPass Micro-Stent n=48 Participants Subjects received the CyPass Micro-Stent
Age, Continuous	68 years STANDARD_DEVIATION 10.96 • n=93 Participants
Sex: Female, Male Female	32 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants
Region of Enrollment Austria	4 participants n=93 Participants
Region of Enrollment Bulgaria	8 participants n=93 Participants
Region of Enrollment Germany	33 participants n=93 Participants
Region of Enrollment Spain	3 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline; Month 12 postoperative

Population: Eyes implanted with the CyPass 2FX device with data available.

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.

Outcome measures

Measure	CyPass Micro-Stent n=42 Participants Subjects received the CyPass Micro-Stent
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline	60.4 percentage of eyes

SECONDARY outcome

Timeframe: Month 12 postoperative

Population: Eyes implanted with the CyPass 2FX device with data available.

Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.

Outcome measures

Measure	CyPass Micro-Stent n=43 eyes Subjects received the CyPass Micro-Stent
Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication	81.4 percentage of eyes

SECONDARY outcome

Timeframe: Baseline, Month 12 postoperative

Population: Eyes implanted with the CyPass 2FX device with data available.

The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.

Outcome measures

Measure	CyPass Micro-Stent n=43 eyes Subjects received the CyPass Micro-Stent
Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline Baseline	2.1 medications Standard Deviation 0.99
Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline Month 12	1.4 medications Standard Deviation 1.3

Adverse Events

Non-Ocular Adverse Events

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Ocular Adverse Events

Serious events: 8 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Non-Ocular Adverse Events n=48 participants at risk At risk population for non-ocular adverse events is included with unit of subjects	Ocular Adverse Events n=50 participants at risk At risk population for ocular adverse events is included with unit of eyes.
Injury, poisoning and procedural complications Secondary surgical intervention	0.00% 0/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	6.0% 3/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Investigations IOP above target	0.00% 0/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	10.0% 5/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
General disorders Death	2.1% 1/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	0.00% 0/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	2.1% 1/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	0.00% 0/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.

Other adverse events

Measure	Non-Ocular Adverse Events n=48 participants at risk At risk population for non-ocular adverse events is included with unit of subjects	Ocular Adverse Events n=50 participants at risk At risk population for ocular adverse events is included with unit of eyes.
Eye disorders Hyphema	0.00% 0/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	6.0% 3/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Eye disorders BCVA loss ≥ 2 lines at/after 3 months postoperatively	0.00% 0/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	24.0% 12/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Injury, poisoning and procedural complications Secondary surgical intervention: IOP management	0.00% 0/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	26.0% 13/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Investigations IOP ≥ 10 mmHg over baseline or > 30 mmHg at/after 1 month postoperatively	0.00% 0/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	20.0% 10/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Investigations CyPass device obstruction	0.00% 0/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	12.0% 6/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Injury, poisoning and procedural complications Secondary surgical intervention: Cataract removal	0.00% 0/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	22.0% 11/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Injury, poisoning and procedural complications Secondary surgical intervention: CyPass obstruction lysis	0.00% 0/48 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.	10.0% 5/50 • An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative). Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.

Additional Information

Vice President of Medical Affairs

Transcend Medical, Inc.

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER