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The Effects of the Water Drinking Test on Intraocular Pressure

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Cheryl Goodness, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01507584
First received: September 1, 2011
Last updated: January 6, 2012
Last verified: January 2012
History of Changes

September 1, 2011
January 6, 2012
August 2011
June 2012   (final data collection date for primary outcome measure)
  • 24-hour IOP patterns [ Time Frame: 24-hour ] [ Designated as safety issue: No ]
    Assess IOP patterns between day and night time and changes after the WDT.
  • Intraocular pressure [ Time Frame: 24-hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01507584 on ClinicalTrials.gov Archive Site
ocular adverse events [ Time Frame: 24-hours ] [ Designated as safety issue: Yes ]
appearance of any device- or non-device-related ocular adverse events
Same as current
Not Provided
Not Provided
 
The Effects of the Water Drinking Test on Intraocular Pressure
The Effects of the Water Drinking Test on Intraocular Pressure of Glaucoma Patients Undergoing 24 Hour Continuous Monitoring With the SENSIMED Triggerfish

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Glaucoma
Device: SENSIMED Triggerfish
Comparison of fluctuation of Intraocular pressures with different class of drugs
Other Name: bimatoprost (Lumigan); brinzolamide (azopt)
  • Active Comparator: Prostaglandin Analogue
    Intervention: Device: SENSIMED Triggerfish
  • Active Comparator: Carbonic Anhydrase Inhibitor
    Intervention: Device: SENSIMED Triggerfish
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
September 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01507584
110903
No
Cheryl Goodness, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Kaweh Mansouri, MD University of California, San Diego
University of California, San Diego
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP