A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial (COMPASS-XT)

Alcon

Status: Completed

Conditions: Primary Open Angle Glaucoma (POAG)

Treatments: Procedure: Cataract Surgery; Device: CyPass Micro-Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02700984

TMI-09-01-E

GLD122b-C001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.

Full description

The COMPASS Trial (TMI-09-01) was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the CyPass Micro-Stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. In the study, 505 subjects were randomized to either the CyPass group, who underwent cataract surgery and received the CyPass Micro-Stent, or the Control group, who underwent cataract surgery alone. All subjects randomized were to be followed for 2 years postoperatively. Four hundred eighty (480) subjects completed this study.

The COMPASS-XT (TMI-09-01-E) Trial is designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data will be collected at 36 months, 48 months, and 60 months postoperatively for a total of 5 year follow-up across the 2 studies.

Enrollment: 282 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Completed the COMPASS Trial
2. Understands study requirements and is willing to follow study instructions and return for study visits

Exclusion criteria

1. Systemic disease that would put subject health at risk and/or prevent completion of required study visits.
2. Early termination from the COMPASS Trial.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

Cataract Surgery + CyPass

Experimental group

Description:

CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)

Treatment:

Device: CyPass Micro-Stent

Procedure: Cataract Surgery

Cataract Surgery Only

Active Comparator group

Description:

Cataract Surgery (COMPASS trial) with no CyPass Micro-Stent implantation

Treatment:

Procedure: Cataract Surgery