N/A
N=23
The Effects of the Water Drinking Test on Intraocular Pressure
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01507584 ↗Enrolled (actual)
23
Serious AEs
—
Results posted
Sep 2019
Primary outcome: Primary: 24-hour IOP Patterns
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SENSIMED Triggerfish (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24-hour IOP Patterns |
— | — |
| PRIMARY Intraocular Pressure |
— | — |
| SECONDARY Ocular Adverse Events |
— | — |
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 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01507584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.