Clinical trial NCT02700984: A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial
Official title: An Observational Multicenter Clinical Study to Assess the Long-Term Safety of the CyPass Micro-Stent in Patients With Primary Open Angle Glaucoma Who Have Completed Participation in the COMPASS Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma (POAG)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Transcend Medical, Inc.
First posted: 2016-03-07
Enrollment: 282
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group
timeFrame: Up to Month 60 postoperative
Secondary outcomes:
measure: Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
timeFrame: Baseline, Month 12, 24, 36, 48, 60 postoperative
measure: Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye
timeFrame: Up to Month 60 postoperative
measure: Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema
timeFrame: Month 36, 48, 60 postoperative
measure: Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
timeFrame: Month 36, 48, 60 postoperative
measure: Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells
timeFrame: Month 36, 48, 60 postoperative
measure: Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare
timeFrame: Month 36, 48, 60 postoperative
measure: Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion
timeFrame: Month 36, 48, 60 postoperative
measure: Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking
timeFrame: Month 36, 48, 60 postoperative
measure: Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis
timeFrame: Month 36, 48, 60 postoperative
measure: Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity
timeFrame: Month 36, 48, 60 postoperative
measure: Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only
timeFrame: Month 36, 48, 60 postoperative
measure: Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations
timeFrame: Month 36, 48, 60 postoperative
measure: Change From Month 24 in Visual Field Mean Deviation
timeFrame: Month 24, 36, 48, 60 postoperative
measure: Change From Month 24 in Central Corneal Thickness
timeFrame: Month 24, 36, 48, 60 postoperative
measure: Central Corneal Endothelial Cell Density (ECD) by Visit
timeFrame: Baseline, Month 3, 6, 12, 24, 36, 48, 60 postoperative
measure: Number of Subjects With CyPass Device Malposition, Dislodgement or Movement
timeFrame: Up to 60 months postoperatively
measure: Mean Reduction From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, Month 36, 48, 60 postoperative
measure: Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications
timeFrame: Baseline, Month 36, 48, 60 postoperative
measure: Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg
timeFrame: Month 36, 48, 60 postoperative
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Alcon Investigative Site
state: Arizona
city: Fayetteville
country: United States
facility: Alcon Investigative Site
state: Arkansas
city: La Jolla
country: United States
facility: Alcon Investigative Site
state: California
city: Orange
country: United States
facility: Alcon Investigative Site
state: California
city: Fort Collins
country: United States
facility: Alcon Investigative Site
state: Colorado
city: Parker
country: United States
facility: Alcon Investigative Site
state: Colorado
city: Boynton Beach
country: United States
facility: Alcon Investigative Site
state: Florida
city: Cape Coral
country: United States
facility: Alcon Investigative Site
state: Florida
city: Sioux City
country: United States
facility: Alcon Investigative Site
state: Iowa
city: Garden City
country: United States
facility: Alcon Investigative Site
state: Kansas
city: Boston
country: United States
facility: Alcon Investigative Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Alcon Investigative Site
state: Missouri
city: Vineland
country: United States
facility: Alcon Investigative Site
state: New Jersey
city: Cincinnati
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Alcon Investigative Site
state: Oklahoma
city: Kingston
country: United States
facility: Alcon Investigative Site
state: Pennsylvania
city: West Mifflin
country: United States
facility: Alcon Investigative Site
state: Pennsylvania
city: Maryville
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Alcon Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Alcon Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Alcon Investigative Site
state: Texas
Study officials:
affiliation: Alcon Research
name: Alcon, Research
role: STUDY_DIRECTOR
References: