Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Ocular Hypertension
Brinzolamide
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014