lowering intraocular pressure
Conditions
Interventions
Not applicable.
Sponsors
Ivantis, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male and female patients, from 21 to 80 years of age. • A diagnosis of primary open angle glaucoma (POAG) or pseudoexfoliative glaucoma. • At the Screening Visit, a mean (or median) IOP of = 21 mmHg and = 21 mmHg and = 3 months prior to enrollment, optical scanning lasers and optic disc photography confirming disc morphology may be used to establish the diagnosis of glaucoma. Acceptable optical scanning laser diagnostics include: 1. Heidelberg Retina Tomography (HRT) abnormal nerve fiber layer (NFL) findings indicated by a yellow exclamation mark and/or a red x. 2. Zeiss/Humphrey Glaucoma Diagnostic unit - GDx abnormal NFL findings with a Nerve Fiber Index (NFI) reading of > 31 and/or = III. • Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits.
Exclusion criteria
Exclusion criteria: • Closed angle forms of glaucoma. • Secondary glaucoma (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venuous pressure; congenital or developmental glaucoma. • Significant risk due to washout of medication. • Previous argon laser trabeculoplasty (ALT), cyclodestructive procedure, trabeculectomy, tube shunts, or any incisional glaucoma surgical procedure. • Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at screening (fixation losses, false positive errors and false negative errors shoud not be greater than 33%). • Use of more than 4 ocular hypotensive medications. (Note: Combination medications count as 2 medications.) • Central corneal thickness > 620 or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint for this study is IOP at 12 months following the terminal wash-out of all glaucoma medications. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary effectiveness endpoints include: • The proportion of eyes with reduction in IOP of at least 20% following wash-out, as compared to the washed-out baseline in each study group. • Change in best corrected visual acuity (BCVA) as measured by EDTRS, in the study eye from baseline to 12 months. • The proportion of eyes with IOP > 5 mmHg to £ 19 mmHg at 12 months post washout. • Diurnal IOP at 24 months following the wash-out of all glaucoma medications. • Diurnal IOP at 36 months following the wash-out of all glaucoma medications. | — |
Countries
Netherlands
Outcome results
None listed