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
  Purpose

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.


Condition Intervention Phase
Glaucoma
Device: SENSIMED Triggerfish
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effects of the Water Drinking Test on Intraocular Pressure of Glaucoma Patients Undergoing 24 Hour Continuous Monitoring With the SENSIMED Triggerfish

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • ocular adverse events [ Time Frame: 24-hours ] [ Designated as safety issue: Yes ]
    appearance of any device- or non-device-related ocular adverse events


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prostaglandin Analogue Device: SENSIMED Triggerfish
Comparison of fluctuation of Intraocular pressures with different class of drugs
Other Name: bimatoprost (Lumigan); brinzolamide (azopt)
Active Comparator: Carbonic Anhydrase Inhibitor Device: SENSIMED Triggerfish
Comparison of fluctuation of Intraocular pressures with different class of drugs
Other Name: bimatoprost (Lumigan); brinzolamide (azopt)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507584

Locations
United States, California
Hamilton Glaucoma Center, UCSD
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Kaweh Mansouri, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: Cheryl Goodness, Professor of Clinical Ophthalmology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01507584     History of Changes
Other Study ID Numbers: 110903
Study First Received: September 1, 2011
Last Updated: January 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Carbonic Anhydrase Inhibitors
Brinzolamide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014