Status:
COMPLETED
The Effects of the Water Drinking Test on Intraocular Pressure
Lead Sponsor:
University of California, San Diego
Conditions:
Glaucoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 mon...
Detailed Description
The investigation will recruit male and female patients 18-80 years old and diagnosed with glaucoma or ocular hypertension requiring hypotensive ocular treatment. Up to 100 subjects will be enrolled i...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01507584
Start Date
August 1 2011
End Date
April 30 2013
Last Update
September 11 2019
Active Locations (1)
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1
Hamilton Glaucoma Center, UCSD
La Jolla, California, United States, 92093