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The Effects of the Water Drinking Test on Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT01507584
Recruitment Status : Unknown
Verified January 2012 by Cheryl Goodness, University of California, San Diego.
Recruitment status was:  Enrolling by invitation
First Posted : January 11, 2012
Last Update Posted : January 11, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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 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 or disease Intervention/treatment Phase
Glaucoma Device: SENSIMED Triggerfish Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. 24-hour IOP patterns [ Time Frame: 24-hour ]
    Assess IOP patterns between day and night time and changes after the WDT.

  2. Intraocular pressure [ Time Frame: 24-hours ]

Secondary Outcome Measures :
  1. ocular adverse events [ Time Frame: 24-hours ]
    appearance of any device- or non-device-related ocular adverse events


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

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