The Effects of the Water Drinking Test on Intraocular Pressure

Completed · Not applicable

Conditions studied: Glaucoma

In brief

This clinical trial is designed to investigate the efficacy profile of the SENSIMED Triggerfish® during 24-hour IOP monitoring in patients with glaucoma or ocular hypertension, done three times at monthly intervals under different therapeutic regimen. This trial will also evaluate the efficacy of SENSIMED Triggerfish® to detect changes in intraocular pressure (IOP) after the water drinking test (WDT) will be investigated.

Key facts

Study ID

NCT01507584

Run by

University of California, San Diego

People needed

23

Starts

2011-08-01

Expected to finish

2013-04-30

Last updated by the study team

2019-09-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able to comply with the study procedures
• 18-80 years old
• Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of > 22 mmHg at the screening visit and under ocular hypotensive treatment.
• Subject has consented to be in the trial
• Visual acuity of 20/80 or better
• Ability to understand the character and individual consequences of the study
• For women of childbearing potential, adequate contraception
• Stable anti-hypertensive treatment regimen 4 weeks prior to the screening visit and throughout the study.

You may not qualify if…

• Subjects with chronic kidney failure and chronic hear disease
• Subjects with contraindications for wearing contact lenses
• Severe dry eye syndrome
• Keratoconus or other corneal abnormality
• Conjunctival or intraocular inflammation
• Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery and laser a minimum of 3 months prior to the screening visit.
• Full frame metal glasses during SENSIMED Triggerfish® monitoring
• Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
• Pregnancy and lactation
• Simultaneous participation in other clinical studies
• No patient will be allowed to participate in this trial more than once

Where it is running

• Hamilton Glaucoma Center, UCSD — La Jolla, California, United States

Full record on ClinicalTrials.gov

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