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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01539239
Other study ID # CP-11-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date June 2020

Study information

Verified date February 2021
Source Ivantis, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.


Recruitment information / eligibility

Status Completed
Enrollment 1143
Est. completion date June 2020
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: - An operable age-related cataract - A diagnosis of POAG treated with 1 to 4 hypotensive medications - Medicated IOP = 31 mmHg - Diurnal IOP = 22 mmHg and = 34 mmHg Exclusion Criteria: - Congenital or developmental glaucoma - Previous argon laser trabeculoplasty - Ab-interno or ab-externo device implanted in or through Schlemm's Canal - Use of oral hypotensive medication for glaucoma for treatment of fellow eye

Study Design


Intervention

Device:
Hydrus Aqueous Implant
The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
Procedure:
Cataract surgery
A monofocal intraocular lens (IOL) placed during the cataract surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ivantis, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Mexico,  Philippines,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications. Baseline and 24 months
Secondary Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications. Baseline and 24 months
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